Hidradenitis Suppurativa Associated With Increased Stroke Risk


The following article is part of our coverage of the American Academy of Dermatology’s annual meeting (AAD 2021) that is being held virtually from April 23-25, 2021. Dermatology Advisor‘s staff will report on the top research in dermatologic advances and clinical care. Check back for the latest news from AAD 2021.

 

The risk for stroke in patients with hidradenitis suppurativa (HS) are significantly increased when compared with control patients, according to the pooled findings of a systematic review and meta-analysis presented at the American Academy of Dermatology’s Virtual Meeting Experience (AAD VMX) 2021, held online from April 23 to April 25, 2021.


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Researchers performed the analyses via preferred reporting items for systematic reviews and meta-analyses (PRISMA) guidelines, using electronic searches of EMBASE, PubMed, and Ovid MEDLINE, and included all eligible case-control studies that compared patients with HS and patients without HS.

Eligible studies identified patients with strokes by ICD-9 or -10 codes and included either the percentage of patients in each group or the summary effect size for association of HS and strokes. For the effect size, odds ratio (OR) with 95% CI was used. Key search terms included HS, acne inversa, Down syndrome, velpeau, and verneuil. Investigators conducted a manual review to identify additional articles. For meta-analysis, the logit proportion was used as a summary statistic and random-effects model, and heterogeneity was tested with χ2 and I2 tests.

In total, 47 studies were identified, and 6 case-controlled studies were included. After analyzing pooled data, researchers found there was a significantly higher percentage of strokes among HS patients compared with control patients (OR 1.51; 95% CI, 1.16-1.96; P <.00001), with moderate heterogeneity present (I2=70%). The meta-analysis and systematic review showed HS to be associated with a significant 1.74-fold increased risk for stroke.

Studies have identified increased expression of tumor necrosis factor (TNF)-alpha and pro-inflammatory cytokines, such as interleukin 1β (IL-β), IL-12, IL-17, in the skin of patients with HS. These cytokines have been associated with atherosclerosis. Furthermore, according to the researchers, HS is associated with other cardiovascular risk factors such as smoking, hypertriglyceridemia, obesity, and diabetes mellitus.

Study limitations included the following: the reviewed studies were observational, which makes them inherently susceptible to bias and a lack of randomization and heterogeneity. Other demographic factors could impact results for this same reason, it was noted. The studies also failed to differentiate between the different stroke subtypes, which resulted in theories explaining the relationship between HS and ischemic stroke, and a distinct lack of information concerning hemorrhagic stroke.

Researchers indicated that dermatologists and other clinicians treating this patient group should be made aware of this association, which they believe is not currently well known. The study investigators concluded, “Our pooled findings demonstrate that the odds of stroke are increased in patients with HS when compared with [control patients]. Dermatologists and other clinicians should be vigilant of cerebrovascular risk assessment and risk mitigation in patients with HS.”

Reference

Phan K, Ng W, Lai B, Garg A, Smith SD. Hidradenitis suppurativa and association with stroke: systematic review and meta-analysis. Presented at: AAD VMX 2021; April 23-25, 2021. Abstract/Poster 28464.

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Effectiveness of interdisciplinary combined dermatology-gastroenterology-rheumatology clinical care compared to usual care in patients with immune-mediated inflammatory diseases: a parallel group, non-blinded, pragmatic randomised trial

This article was originally published here

BMJ Open. 2021 Apr 28;11(4):e041871. doi: 10.1136/bmjopen-2020-041871.

ABSTRACT

INTRODUCTION: Immune-mediated inflammatory diseases (IMIDs) are associated with reduced health-related quality of life (HRQol), increased risk of somatic and psychiatric comorbidities and reduced socioeconomic status. Individuals with one IMID have an increased risk for developing other IMIDs. The unmet needs in the care of patients with IMIDs may result from a lack of patient-centricity in the usual monodisciplinary siloed approach to these diseases. The advantages of novel interdisciplinary clinics towards the traditional therapeutic approach have not been investigated. The overall aim of this study is to determine the effectiveness of an interdisciplinary combined clinic intervention compared with usual care in a population of patients with the IMIDs: psoriasis, hidradenitis suppurativa, psoriatic arthritis, axial spondyloarthritis and inflammatory bowel disease. Our hypothesis is that an interdisciplinary combined clinic intervention will be more effective than usual care in improving clinical and patient-reported outcomes, and that a more effective screening and management of other IMIDs and comorbidities can be performed.

METHODS AND ANALYSIS: This is a randomised, usual care controlled, parallel-group pragmatic clinical trial. 300 consecutively enrolled participants with co-occurrence of at least two IMIDs are randomly assigned in a 2:1 ratio to either treatment in the interdisciplinary combined clinic or usual care. The study will consist of a 6-month active intervention period and a 6-month follow-up period where no intervention or incentives will be provided by the trial. The primary outcome is the change from baseline to 24 weeks on the Short-Form Health Survey (SF-36) Physical Component Summary. Additional patient-reported outcome measures and clinical measures are assessed as secondary outcomes.

ETHICS AND DISSEMINATION: Ethical approval of this study protocol was established by the institutional review board of the study site. The findings from this trial will be disseminated via conference presentations and publications in peer-reviewed journals, and by engagement with patient organisations.

TRIAL REGISTRATION NUMBER: NCT04200690.

PMID:33910945 | DOI:10.1136/bmjopen-2020-041871

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Hidradenitis Suppurativa Treatment Market 2021 Industry Size, Share, Growth and Top Companies Analysis- GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer, AbbVie, etc.

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Competitors Landscape

Key players in the market include

GlaxoSmithKline
Johnson & Johnson
Merck
Pfizer
AbbVie
Allergan
AstraZeneca

This report offers a comprehensive view regarding the competitive landscape of the Hidradenitis Suppurativa Treatment market and includes a broad description of performance by some of the key global players completing in the market. It offers a list of latest updates of several business strategies including mergers, acquisitions, partnerships, product launch, expansion of production units, and collaborations adopted by these major global players. The report provides a clear picture regarding R&D investment from key players and adoption of innovative technologies to widen their consumer base and expand the existing competitive position. Moreover, the report offers a detailed information about the position, scope of growth, and opportunities of new entrants or players in the market.

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Keeping a view to grasp the overall prospect of the market, the report explains key drivers, opportunities, restraints, and challenges focusing on the current market trend and evaluates the prospects of the future market. The report offers an extensive study of the market segments and sub-segments with a clear explanation of which segment is expected to dominate the market during the forecast period.

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The global Hidradenitis Suppurativa Treatment market is divided into

Medications
Surgery
Others

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Applications

The global Hidradenitis Suppurativa Treatment market is categorized into

Hospitals
Clinics
Others

The report lists a wide range of applications of Hidradenitis Suppurativa Treatment and covers the major industries that extensively use the product for their various applications. A detailed explanation is provided in the report about the areas of applications describing where the product is adopted by key industries to leverage their business portfolio. It also provides information about factors that help expand market scope of some of the key applications, their revenue share of each application, and their segment parameters to grasp a complete sense of the segment.

Regional Analysis

The global Hidradenitis Suppurativa Treatment market is classified as

Asia Pacific

Europe

North America

Latin America

Middle East & Africa

This research report widely covers the revenue share, potential growth opportunities, and projected growth rate focusing on five major regions namely Asia Pacific, Europe, North America, Latin America, and Middle East & Africa. Additionally, the report includes a broad analysis of which sub-regions and countries within a region, which are expected to dominate the regional market during the forecast period. The report provides vital information regarding socio-economic and political factors that can influence the overall performance and growth rate of the respective regional markets. A special chapter is reserved in the report for the COVID-19 pandemic and its impacts on the regional market and further explains how this pandemic is projected to influence consumers’ behavior of the Hidradenitis Suppurativa Treatment market in the coming years. The report also focuses on elaborating the roles and impacts of the existing regional trade regulations and government policies & regulations that can either boost or hinder the regional market expansion.

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Some Major TOC Points:

Chapter 1. Report Overview

Chapter 2. Global Growth Trends

Chapter 3. Market Share by Key Players

Chapter 4. Breakdown Data by Type and Application

Chapter 5. Market by End Users/Application

Chapter 6. COVID-19 Outbreak: Hidradenitis Suppurativa Treatment Industry Impact

Chapter 7. Opportunity Analysis in Covid-19 Crisis

Chapter 8. Market Driving Force

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What Happened at AAD VMX 2021?

This past weekend, the staff at Dermatology Times covered the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX 2021). Below you can find a variety of conference-related articles we published, ranging from psoriasis to skin cancer. Click the links to read full-length stories on all of the latest news coming out of AAD VMX 2021.

AAD Finds One Third of American’s Fail Quiz on Skin Cancer

A survey from the American Academy of Dermatology found that younger generations lack skin cancer knowledge.

Deucravacitinib Safe, Effective for Psoriasis

In recent phase 3 trials, deucravacitinib demonstrated progress toward becoming a potential new treatment in moderate to severe plaque psoriasis.

Revance Presents Study Data on DAXI and HA Filler at AAD VMX

Revance presents 4 AAD VMX ePoster abstracts examining phase 3 study data for DAXI, and the impact of HA filler manufacturing technologies on HA chain degradation.

Step up Surveillance Strategies for Skin Cancer

More detailed tumor classifications, patient data advance surveillance strategies for the high-risk patient population.

Tips to Improve High-Risk Skin Cancer Management

In part 2 of this skin cancer report from the American Academy of Dermatology Virtual Meeting Experience 2021 (AAD VMX), an expert shares pearls on regular medication reviews.

Voltaire-X Phase 3 Data for Chronic Plaque Psoriasis Support Interchangeability Application

Voltaire-X study data shows that switching several times between Cyltezo and Humira results in similar pharmacokinetics, efficacy, immunogenicity, and safety in people with moderate to severe chronic plaque psoriasis.

‘Zoom Dysmorphia’ Becoming Rising Issue Among Patients

A survey found a large proportion of dermatologists surveyed said their patients referenced video conferencing as the reason for seeking cosmetic consultation since the start of the pandemic.

Bimekizumab Beats Secukinumab in Skin Clearance for Psoriasis

In phase 3b data presented at the American Academy of Dermatology (AAD) Virtual Meeting Experience (VMX) 2021 showed bimekizumab achieved superior levels of complete skin clearance compared to secukinumab for psoriasis.

Otezla Phase 3 ADVANCE Trial Reports Improvement in Plaque Psoriasis Severity

Phase 3 trial of Otezla shows improved measures of disease severity in adults with mild to moderate plaque psoriasis regardless of their Body Surface Area affected by the disease.

Phase 2 Study of Ruxolitinib Cream for Vitiligo Announces New Findings

Incyte’s Phase 2 study evaluating ruxolitinib cream for vitiligo meets primary endpoint, shows improvement in body and facial repigmentation compared to placebo.

Game Changers in Dermatology

Experts in core dermatological specialties share their insights on the game-changing research and innovation that advancing skin disease management and patient care.

Tremfya Phase 3 Data Show Continued Clearance After 5 Years

Tremfya phase 3 data shows skin clearance rates were maintained at 5 years with 55.5% of patients achieving an IGA score of 0% and 53% achieving PASI 100 response in VOYAGE 2 trial.

New Officers, Board Members Elected to AAD

The American Academy of Dermatology Announced the results from its annual election, with 2 officers and 4 board members assuming their new positions in March 2022.

Clearing the Confusion Around Specific Dermatoses of Pregnancy

In a presentation at the American Academy of Dermatology Virtual Meeting, Marcia S. Driscoll, MD, PharmD, gave guidelines for diagnosing and treating four dermatoses of pregnancy.

Medical, Surgical Tactics Help Manage HS

Thanks to new drug approvals, medical management is replacing surgery as the first-line treatment for inflammation caused by hidradenitis suppurativa. However, surgery is often necessary to relieve pain related to tunnels.

Aesthetic Device Considerations for Skin of Color

Patients of color make up a growing market for aesthetic dermatology. Physicians must learn how to tailor treatments and assess skin of color risk to best serve this emerging patient population. Doing so will deliver positive outcomes and drive patient satisfaction.

Can Telemedicine Survive Beyond COVID-19?

Telemedicine flourished among dermatology practices in the wake of COVID-19. But as the world tentatively reopens, questions about connectivity, regulations, and payment will have to be addressed before physicians decide what role virtual visits will play in their practices.

Hair Restoration Goes High-Tech

Futuristic tools including robotics and new types of lasers are just some of the therapeutic innovations aimed at slowing hair loss and increasing hair growth.

Study: Roflumilast Foam Safe, Effective for Scalp and Body Psoriasis

New data on the safety and efficacy of roflumilast foam (ARQ-154, Arcutis Biotherapeutics) for scalp and body psoriasis was presented at the American Academy of Dermatology Virtual Meeting Experience (AAD VMX) 2021.

Pediatric Atopic Dermatitis Linked to Learning Disabilities

According to objective and subjective measures, children with more severe atopic dermatitis were more likely to report a learning disability.

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ChemoCentryx Reports First Quarter 2021 Financial Results and Recent Highlights Nasdaq:CCXI

— Applications for regulatory approval of avacopan in ANCA-associated vasculitis under review in the United States, Europe and Japan; PDUFA goal date of July 7, 2021, with Advisory Committee scheduled for May 6 —

— Novel orally administered checkpoint inhibitor CCX559 featured at American Association for Cancer Research Annual Meeting, expected to enter clinical development as a next generation cancer treatment in Q2 2021 —

— Other avacopan programs: severe Hidradenitis Suppurativa (HS) Phase III and Lupus Nephritis development initiation on track for 2H 2021 —

— $424 million in cash and investments at March 31, 2021 —

— Conference call today at 5:00 p.m. Eastern Time —

SAN CARLOS, Calif., April 29, 2021 (GLOBE NEWSWIRE) — ChemoCentryx, Inc., (Nasdaq: CCXI), today announced financial results for the first quarter ended March 31, 2021 and provided an overview of recent corporate highlights.

“Momentum builds with each passing quarter, bringing us closer to our goal of bringing novel, precisely targeted medicine to those that need it most,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer of ChemoCentryx. “At our R&D Day earlier this month, two world-renowned clinicians outlined the unmet needs in ANCA-associated vasculitis and the data driving their conviction that avacopan could become a landscape-changing therapy. We are well prepared and look forward to providing our views at the FDA Advisory Committee meeting on this topic in just a few days. During our R&D Day we also took the opportunity to establish how our novel small molecule PD-1/PD-L1 inhibitor CCX559 could transcend current limitations in the treatment of cancer. Meanwhile we are progressing toward our next cycle of clinical trials: a Phase III trial of avacopan in patients with severe HS; the initiation of clinical development of avacopan in lupus nephritis, and our first in human studies of the novel orally administered checkpoint inhibitor CCX559 in cancer patients. We look forward to an historic year of 2021 at ChemoCentryx, and we will devote all our energies to making the dream of breakthrough new therapies a reality for patients.”

Key First Quarter 2021 Highlights and Recent Developments

  • In April, the Company held an R&D Day which focused on avacopan in ANCA-associated vasculitis, with a patient describing his journey with the disease, and the Company’s novel checkpoint inhibitor CCX559.
    • Two leading clinical experts on ANCA-associated vasculitis, Dr. Peter Merkel from the University of Pennsylvania and Dr. David Jayne from the University of Cambridge, explained in detail the widespread effects of this devastating disease and the shortcomings of current therapy with glucocorticoids and other immunosuppressive drugs.  Drs. Merkel and Jayne expressed their belief that avacopan could transform the treatment landscape for ANCA-associated vasculitis.
    • The Company reported new data from the ADVOCATE trial, covering an 8 week period immediately following the 52-week endpoint. During this period from week 52 to week 60, there were 6 relapses out of 158 in the avacopan group and 7 relapses out of 157 in the prednisone group, suggesting a waning of efficacy after drug treatment is stopped. In addition, the estimated Glomerular Filtration Rate (eGFR), which had increased in the avacopan group through week 52, declined in the 8 weeks after patients stopped taking avacopan.
    • Tausif “Tosh” Butt, who joined the Company in February 2021 as Executive Vice President and Chief Operating Officer, summarized the Company’s preparations and readiness for the anticipated commercial launch of avacopan shortly after its PDUFA goal date. He reported on primary market research that a survey of 125 rheumatologists and nephrologists indicated that 97% would prescribe avacopan upon FDA approval. The Company plans to focus initially on the estimated eight thousand patients who are newly diagnosed or relapsing with organ or life-threatening disease, out of an estimated eligible patient population for avacopan of twenty thousand patients.
  • CCX559 was featured in an abstract at the 2021 Annual Meeting of the American Association for Cancer Research (AACR) in April. The abstract highlighted laboratory and in vivo data demonstrating potent PD-1/PD-L1 checkpoint inhibition. As a next generation therapy, small molecule inhibitors of PD-L1 may have advantageous properties compared to approved monoclonal antibodies, such as better penetration into solid tumors and reduced immunogenicity. The Company plans to initiate Phase I clinical development of CCX559 in Q2 2021.
  • In February, The New England Journal of Medicine (NEJM) published the results of the Company’s Phase III ADVOCATE trial of avacopan in ANCA-associated vasculitis, in which avacopan achieved statistical superiority in sustained remission at 52 weeks over prednisone containing standard of care. The same issue of NEJM featured an editorial entitled “Avacopan – Time to Replace Glucocorticoids?”.
  • In February the Japanese New Drug Application for avacopan in the treatment of ANCA-associated vasculitis was accepted for review by the Pharmaceuticals and Medical Devices Agency (PMDA), triggering a milestone payment of $10 million to ChemoCentryx from its partner Vifor Pharma.
  • The Company plans to advance avacopan into Phase III development in patients with Hurley Stage III (severe) HS in Q4 2021. In the Phase II AURORA trial, avacopan demonstrated a statistically significant higher response than placebo in Hurley Stage III patients.
  • The Company plans to initiate clinical development of avacopan in patients with lupus nephritis in Q4 2021.
  • The Company plans to schedule a meeting with the FDA to discuss evidence of clinical benefit from the ACCOLADE trial of avacopan in the very rare disorder C3 Glomerulopathy (C3G), for which there are no approved therapies. In the trial, avacopan demonstrated statistically significant improvement in renal function as measured by the pre-specified endpoint of eGFR and in the pre-specified secondary endpoint of C3G Histology Index (HI) Disease Chronicity score, compared to placebo over 26 weeks of blinded treatment, but did not achieve a statistically significant improvement in the primary endpoint of the C3G HI Disease Activity Score. Avacopan was safe and well tolerated in C3G patients.
  • The Company maintained a strong balance sheet, with reported cash, cash equivalents and investments of $424.2 million at March 31, 2021.

First Quarter 2021 Financial Results

Revenue was $10.4 million for the first quarter of 2021, compared to $6.0 million for the same period in 2020. The increase in revenue from 2020 to 2021 was principally attributable to the $10.0 million milestone from Vifor for the February 2021 acceptance of the Japanese NDA for avacopan in the treatment of ANCA vasculitis.

Research and development expenses were $23.4 million for the first quarter of 2021, compared to $19.3 million for the same period in 2020. The increase from 2020 to 2021 was primarily attributable to the manufacture of commercial drug supply in anticipation of the launch of avacopan for the treatment of ANCA vasculitis and costs associated with the advancement of CCX559, the Company’s orally-available small molecule checkpoint (PD-1/PD-L1) inhibitor.  These increases were partially offset by lower Phase II related expenses due to the completion of patient enrollment of the avacopan AURORA Phase IIb clinical trial in patients with HS and the discontinuation of further clinical development of CCX140 in FSGS in 2020.

General and administrative expenses were $16.3 million for the first quarter of 2021, compared to $8.8 million for the same period in 2020. The increase from 2020 to 2021 was primarily due to higher employee-related expenses, including those associated with the Company’s commercialization planning efforts, and higher professional fees.  

Net loss for the first quarter of 2021 was $29.7 million, compared to net loss of $21.7 million for the same period in 2020.

Total shares outstanding at March 31, 2021 were approximately 69.7 million shares.

Cash, cash equivalents and investments totaled $424.2 million at March 31, 2021. The Company expects to utilize cash, cash equivalents and investments in the range of $145 million to $155 million in 2021.

Conference Call and Webcast

The Company will host a conference call and webcast today, April 29, 2021 at 5:00 p.m. Eastern Time / 2:00 p.m. Pacific Time. To participate by telephone, please dial (877) 303-8028 (Domestic) or (760) 536-5167 (International). The conference ID number is 3963565. A live and archived audio webcast can be accessed through the Investors section of the Company’s website at www.ChemoCentryx.com. The archived webcast will remain available on the Company’s website for fourteen (14) days following the call.

About ChemoCentryx

ChemoCentryx is a biopharmaceutical company developing new medications for inflammatory and autoimmune diseases and cancer. ChemoCentryx targets the chemokine and chemoattractant systems to discover, develop and commercialize orally administered therapies. ChemoCentryx’s lead drug candidate, avacopan (CCX168), successfully completed a pivotal Phase III trial in ANCA-associated vasculitis and a New Drug Application is under review by the U.S. Food and Drug Administration. Avacopan is also in late stage clinical development for the treatment of severe Hidradenitis Suppurativa and C3 glomerulopathy (C3G).

ChemoCentryx also has early stage drug candidates that target chemoattractant receptors in other inflammatory and autoimmune diseases and in cancer.

Forward-Looking Statements
ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential,” “continue” or “project” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include the Company’s statements regarding the achievement of anticipated goals and milestones, whether avacopan will be approved by the FDA, EMA or PMDA for the treatment of ANCA-associated vasculitis, the timing of the FDA’s, EMA’s and PMDA’s decision on the NDA, MAA, and JNDA, respectively, the timing of the potential commercial launch of avacopan in ANCA-associated vasculitis, whether avacopan will be an effective treatment in other indications such as severe HS, C3G and lupus nephritis, whether a Phase III trial of avacopan in patients with severe HS will commence in Q4 2021, whether avacopan for lupus nephritis and CCX559 will enter clinical trials in 2021 in Q4 2021 and Q2 2021, respectively, whether actual cash utilization will fall within projections and whether the Company’s drug candidates will be shown to be effective in ongoing or future clinical trials. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s Annual Report on Form 10-K filed with the SEC on March 1, 2021 and its other reports which are available from the SEC’s website (www.sec.gov) and on ChemoCentryx’s website (www.chemocentryx.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Contacts:
Susan M. Kanaya
Executive Vice President,
Chief Financial and Administrative Officer
investor@chemocentryx.com 

Media:
Stephanie Tomei
408.234.1279
media@chemocentryx.com

Investors:
Burns McClellan
Lee Roth
212.213.0006
lroth@burnsmc.com

ChemoCentryx, Inc.          
Condensed Consolidated Financial Statements Data          
(in thousands, except per share data)          
    Three Months Ended  
    March 31,  
      2021       2020    
       
    (unaudited)  
Condensed Consolidated Statements of Operations Data:          
Revenue:          
Collaboration and license revenue from related party   $ 10,223     $ 5,855    
Grant revenue     130       153    
Total revenue     10,353       6,008    
           
Operating expenses:          
Research and development     23,418       19,311    
General and administrative     16,262       8,820    
Total operating expenses     39,680       28,131    
Loss from operations     (29,327 )     (22,123 )  
Other income (expense), net     (384 )     436    
Net loss   $ (29,711 )   $ (21,687 )  
           
Basic and diluted net loss per common share   $ (0.43 )   $ (0.35 )  
           
Shares used to compute basic and diluted net loss per common share     69,608       61,295    
           
           
    March 31,   December 31,  
    2021   2020  
    (unaudited)      
Condensed Consolidated Balance Sheets Data:          
Cash, cash equivalents and investments   $ 424,159     $ 460,370    
Working capital     335,911       390,012    
Total assets     499,112       518,899    
Long-term debt, net     24,475       24,401    
Accumulated deficit     (515,053 )     (485,342 )  
Total stockholders’ equity     361,004       385,613    
           

 

 

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Substantial improvements seen with tofacitinib in cutaneous sarcoidosis

April 29, 2021

1 min read

Source:

Damsky W, et al. Treatment of sarcoidosis with cutaneous involvement with tofacitinib: Results of an open-label clinical trial. Presented at: AAD VMX 2021; April 23-25, 2021 (virtual meeting).


Disclosures:
Damsky reports receiving research support from Pfizer, consulting fees from Eli Lilly, Pfizer and TWi Biotechnology and licensing fees from EMD/Millipore/Sigma.


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Tofacitinib treatment in patients with sarcoidosis with cutaneous involvement delivered significant improvements, according to a study presented at AAD VMX 2021.

“Some studies have estimated that up to one in 25 Black women in the U.S. may develop [sarcoidosis inflammatory disorder] during their lifetime. That’s a group where the highest incidence is seen,” William Damsky, MD, PhD, assistant professor in dermatology and dermatopathology at Yale School of Medicine, said during a presentation. “And it can be serious. As many as 4,000 deaths per year have also been estimated to be either directly or indirectly attributable to sarcoidosis.”

The open-label prospective single-center study included 10 patients with sarcoidosis with cutaneous involvement for a minimum of 1 year; nine patients also reported active internal organ disease. Patients received twice-daily tofacitinib for 6 months. At baseline, all patients had a Cutaneous Sarcoidosis Activity and Morphology Instrument (CSAMI) score of 10 or greater.

After 6 months, all patients had improved CSAMI scores, with six reporting complete responses. CSAMI scores were reduced by an average of 82.7%. No serious adverse events occurred as a result of tofacitinib treatment.

“Not only did patients get better, but they were, in many cases, able to come off their baseline immunosuppressive regimen, including prednisone and methotrexate, and get off prednisone entirely, or in some cases just decrease it substantially. It’s really quite remarkable to see that,” Damsky said during the presentation.

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Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Opportunities, Demand and Forecasts Analysis 2021-2027 |Amgen Inc., Johnson & Johnson Services, Inc.

Los Angeles, United States,April 2021,- QY Research has recently published a new report, titled Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size, Status and Forecast 2020-2026. The report has been put together using primary and secondary research methodologies, which offer an accurate and precise understanding of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market. Analysts have used a top-down and bottom-up approach to evaluate the segments and provide a fair assessment of their impact on the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market. The report offers an overview of the market, which briefly describes the market condition and the leading segments. It also mentions the top players present in the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market.

The research report on the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market includes a SWOT analysis and Porter’s five forces analysis, which help in providing the precise trajectory of the market. These market measurement tools help in identifying drivers, restraints, weaknesses, Tumor Necrosis Factor (TNF) Inhibitor Drugs market opportunities, and threats. The research report offers global market figures as well as figures for regional markets and segments therein.

Get a PDF Sample Copy of the Report to understand the structure of the complete report: (Including Full TOC, List of Tables & Figures, Chart) :

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 The Tumor Necrosis Factor (TNF) Inhibitor Drugs research report opens with an executive summary that gives a brief overview of the market. It mentions the leading segments and the players that are expected to shape the market in the coming years. The executive summary offers a glance of the market without any bias. In the succeeding chapters, the research report on the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market focuses on the drivers. It explains the changing demographic that is expected to impact demand and supply in Tumor Necrosis Factor (TNF) Inhibitor Drugs market. It delves into the regulatory reforms that are projected to shift perspectives. Additionally, researchers have discussed the very source of the demand to analyze its nature.

The report also sheds light on the restraints present in the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market. Analysts have discussed the details highlighting the factors that are expected to hamper the growth of the market in the coming years. Evolving lifestyles, taxation policies, and purchasing powers of various economies have scrutinized in great detail. The report presents fair points about how these restraints can be turned into opportunities if assessed properly.

Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Competitive Landscape

The last chapter of the research report on the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market focuses on the key players and the competitive landscape present in the market. The report includes a list of strategic initiatives taken by the companies in recent years along with the ones that are expected to happen in the foreseeable future. Researchers have made a note of the financial outlook of these companies, their research and development activities, and their expansion plans for the near future. The research report on the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market is a sincere attempt at giving the readers a comprehensive view of the market to the interested readers.

Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Leading Players

AbbVie Inc., Amgen Inc., Johnson & Johnson Services, Inc., UCB S.A., Novartis International AG, Pfizer, Inc., Merck & co., Inc., … Tumor Necrosis Factor (TNF) Inhibitor Drugs

Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Segmentation

Through the next chapters, the research report reveals the development of the Tumor Necrosis Factor (TNF) Inhibitor Drugs market segments. Analysts have segmented the market on the basis of product, application, end-users, and geography. Each segment of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market has been studied with in-depth insight. Analysts have evaluated the changing nature of the market segments, growing investments in manufacturing activities, and product innovation that are likely to impact them. In terms of geography, the report studies the changing political environment, social upliftment, and other government initiatives that are expected to contribute to the regional markets.

Tumor Necrosis Factor (TNF) Inhibitor Drugs Segmentation by Product

, Rheumatoid Arthritis, Psoriasis, Psoriatic Arthritis, Crohn’s Disease, Ulcerative Colitis, Ankylosing Spondylitis, Juvenile Idiopathic Arthritis, Hidradenitis Suppurativa, Others

Tumor Necrosis Factor (TNF) Inhibitor Drugs Segmentation by Application

Tumor Necrosis Factor (TNF) Inhibitor Drugs

Questions answered in the report

  • Which are the five top players of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market?
  • How will the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market change in the next five years?
  • Which product and application will take a lion’s share of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market?
  • What are the drivers and restraints of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market?
  • Which regional market will show the highest growth?
  • What will be the CAGR and size of the global Tumor Necrosis Factor (TNF) Inhibitor Drugs market throughout the forecast period?

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Table of Contents

1 Report Overview
1.1 Study Scope
1.2 Key Market Segments
1.3 Players Covered: Ranking by Tumor Necrosis Factor (TNF) Inhibitor Drugs Revenue
1.4 Market Analysis by Type
1.4.1 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size Growth Rate by Type: 2020 VS 2026
1.4.2 Humira
1.4.3 Enbrel
1.4.4 Remicade
1.4.5 Simponi/Simponi Aria
1.4.6 Cimzia
1.4.7 Biosimilars
1.5 Market by Application
1.5.1 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Share by Application: 2020 VS 2026
1.5.2 Rheumatoid Arthritis
1.5.3 Psoriasis
1.5.4 Psoriatic Arthritis
1.5.5 Crohn’s Disease
1.5.6 Ulcerative Colitis
1.5.7 Ankylosing Spondylitis
1.5.8 Juvenile Idiopathic Arthritis
1.5.9 Hidradenitis Suppurativa
1.5.10 Others
1.6 Coronavirus Disease 2019 (Covid-19): Tumor Necrosis Factor (TNF) Inhibitor Drugs Industry Impact
1.6.1 How the Covid-19 is Affecting the Tumor Necrosis Factor (TNF) Inhibitor Drugs Industry

1.6.1.1 Tumor Necrosis Factor (TNF) Inhibitor Drugs Business Impact Assessment – Covid-19

1.6.1.2 Supply Chain Challenges

1.6.1.3 COVID-19’s Impact On Crude Oil and Refined Products
1.6.2 Market Trends and Tumor Necrosis Factor (TNF) Inhibitor Drugs Potential Opportunities in the COVID-19 Landscape
1.6.3 Measures / Proposal against Covid-19

1.6.3.1 Government Measures to Combat Covid-19 Impact

1.6.3.2 Proposal for Tumor Necrosis Factor (TNF) Inhibitor Drugs Players to Combat Covid-19 Impact
1.7 Study Objectives
1.8 Years Considered 2 Global Growth Trends by Regions
2.1 Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Perspective (2015-2026)
2.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Growth Trends by Regions
2.2.1 Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Regions: 2015 VS 2020 VS 2026
2.2.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Historic Market Share by Regions (2015-2020)
2.2.3 Tumor Necrosis Factor (TNF) Inhibitor Drugs Forecasted Market Size by Regions (2021-2026)
2.3 Industry Trends and Growth Strategy
2.3.1 Market Top Trends
2.3.2 Market Drivers
2.3.3 Market Challenges
2.3.4 Porter’s Five Forces Analysis
2.3.5 Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Growth Strategy
2.3.6 Primary Interviews with Key Tumor Necrosis Factor (TNF) Inhibitor Drugs Players (Opinion Leaders) 3 Competition Landscape by Key Players
3.1 Global Top Tumor Necrosis Factor (TNF) Inhibitor Drugs Players by Market Size
3.1.1 Global Top Tumor Necrosis Factor (TNF) Inhibitor Drugs Players by Revenue (2015-2020)
3.1.2 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Revenue Market Share by Players (2015-2020)
3.1.3 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Share by Company Type (Tier 1, Tier 2 and Tier 3)
3.2 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Concentration Ratio
3.2.1 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Concentration Ratio (CR5 and HHI)
3.2.2 Global Top 10 and Top 5 Companies by Tumor Necrosis Factor (TNF) Inhibitor Drugs Revenue in 2019
3.3 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players Head office and Area Served
3.4 Key Players Tumor Necrosis Factor (TNF) Inhibitor Drugs Product Solution and Service
3.5 Date of Enter into Tumor Necrosis Factor (TNF) Inhibitor Drugs Market
3.6 Mergers & Acquisitions, Expansion Plans 4 Breakdown Data by Type (2015-2026)
4.1 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Historic Market Size by Type (2015-2020)
4.2 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Forecasted Market Size by Type (2021-2026) 5 Tumor Necrosis Factor (TNF) Inhibitor Drugs Breakdown Data by Application (2015-2026)
5.1 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020)
5.2 Global Tumor Necrosis Factor (TNF) Inhibitor Drugs Forecasted Market Size by Application (2021-2026) 6 North America
6.1 North America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
6.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in North America (2019-2020)
6.3 North America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
6.4 North America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 7 Europe
7.1 Europe Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
7.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in Europe (2019-2020)
7.3 Europe Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
7.4 Europe Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 8 China
8.1 China Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
8.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in China (2019-2020)
8.3 China Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
8.4 China Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 9 Japan
9.1 Japan Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
9.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in Japan (2019-2020)
9.3 Japan Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
9.4 Japan Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 10 Southeast Asia
10.1 Southeast Asia Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
10.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in Southeast Asia (2019-2020)
10.3 Southeast Asia Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
10.4 Southeast Asia Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 11 India
11.1 India Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
11.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in India (2019-2020)
11.3 India Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
11.4 India Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 12 Central & South America
12.1 Central & South America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size (2015-2020)
12.2 Tumor Necrosis Factor (TNF) Inhibitor Drugs Key Players in Central & South America (2019-2020)
12.3 Central & South America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Type (2015-2020)
12.4 Central & South America Tumor Necrosis Factor (TNF) Inhibitor Drugs Market Size by Application (2015-2020) 13 Key Players Profiles
13.1 AbbVie Inc.
13.1.1 AbbVie Inc. Company Details
13.1.2 AbbVie Inc. Business Overview and Its Total Revenue
13.1.3 AbbVie Inc. Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.1.4 AbbVie Inc. Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020))
13.1.5 AbbVie Inc. Recent Development
13.2 Amgen Inc.
13.2.1 Amgen Inc. Company Details
13.2.2 Amgen Inc. Business Overview and Its Total Revenue
13.2.3 Amgen Inc. Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.2.4 Amgen Inc. Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020)
13.2.5 Amgen Inc. Recent Development
13.3 Johnson & Johnson Services, Inc.
13.3.1 Johnson & Johnson Services, Inc. Company Details
13.3.2 Johnson & Johnson Services, Inc. Business Overview and Its Total Revenue
13.3.3 Johnson & Johnson Services, Inc. Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.3.4 Johnson & Johnson Services, Inc. Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020)
13.3.5 Johnson & Johnson Services, Inc. Recent Development
13.4 UCB S.A.
13.4.1 UCB S.A. Company Details
13.4.2 UCB S.A. Business Overview and Its Total Revenue
13.4.3 UCB S.A. Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.4.4 UCB S.A. Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020)
13.4.5 UCB S.A. Recent Development
13.5 Novartis International AG
13.5.1 Novartis International AG Company Details
13.5.2 Novartis International AG Business Overview and Its Total Revenue
13.5.3 Novartis International AG Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.5.4 Novartis International AG Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020)
13.5.5 Novartis International AG Recent Development
13.6 Pfizer, Inc.
13.6.1 Pfizer, Inc. Company Details
13.6.2 Pfizer, Inc. Business Overview and Its Total Revenue
13.6.3 Pfizer, Inc. Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.6.4 Pfizer, Inc. Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020)
13.6.5 Pfizer, Inc. Recent Development
13.7 Merck & co., Inc.
13.7.1 Merck & co., Inc. Company Details
13.7.2 Merck & co., Inc. Business Overview and Its Total Revenue
13.7.3 Merck & co., Inc. Tumor Necrosis Factor (TNF) Inhibitor Drugs Introduction
13.7.4 Merck & co., Inc. Revenue in Tumor Necrosis Factor (TNF) Inhibitor Drugs Business (2015-2020)
13.7.5 Merck & co., Inc. Recent Development 14 Analyst’s Viewpoints/Conclusions 15 Appendix
15.1 Research Methodology
15.1.1 Methodology/Research Approach
15.1.2 Data Source
15.2 Disclaimer
15.3 Author Details

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DermTech to Collaborate on Lon

DermTech, Inc. (NASDAQ: DMTK) (DermTech), a leader in precision dermatology enabled by a non-invasive skin genomics platform, announced today a collaboration with researchers from the Stanford University School of Medicine, led by principal investigator, Kavita Sarin, MD, PhD, on research titled, A Study of Longitudinal Non-Invasive Cytokine Monitoring in Patients with Hidradenitis Suppurativa. This collaboration highlights DermTechs commitment to using precision genomics and personalized dermatology approaches to improve the understanding of dermatological diseases.

Hidradenitis suppurativa (HS), also known as acne inversa, is a chronic skin condition characterized by recurrent swollen and painful lesions in the armpit (axillae), groin, anal, and breast regions. The primary etiology of HS is not well defined, and consequently in many cases it can take more than seven years from disease onset to properly diagnose HS. The three-year study will utilize DermTechs non-invasive sample collection and precision genomics platform to identify and longitudinally evaluate biomarkers in patients with HS. Specifically, this study will use DermTechs proprietary technology to phenotypically characterize HS, identify potential subsets of HS, and aid in treatment decisions.

Hidradenitis suppurativa is a debilitating skin condition associated with a significant psycho-social burden and an unmet diagnostic and therapeutic need. We are excited to collaborate with the team at Stanford to longitudinally evaluate biomarkers that are associated with disease flares in HS and are committed to improving our understanding of HS as we strive to use precision and personalized dermatology approaches to positively impact those suffering from the disease, said Michael Howell, PhD, DermTechs chief scientific officer.

About DermTech:

DermTech is the leading genomics company in dermatology and is creating a new category of medicine, precision dermatology, enabled by our non-invasive skin genomics platform. DermTechs mission is to transform dermatology with our non-invasive skin genomics platform, to democratize access to high quality dermatology care, and to improve the lives of millions. DermTech provides genomic analysis of skin samples collected non-invasively using an adhesive patch rather than a scalpel. DermTech markets and develops products that facilitate the early detection of skin cancers, and is developing products that assess inflammatory diseases and customize drug treatments. For additional information on DermTech, please visit DermTechs investor relations site at: www.dermtech.com.

Forward-Looking Statements:

This press release includes forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The expectations, estimates, and projections of DermTech may differ from its actual results and consequently, you should not rely on these forward-looking statements as predictions of future events. Words such as expect, estimate, project, budget, forecast, anticipate, intend, plan, may, will, could, should, believes, predicts, potential, continue, and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, expectations with respect to: the performance, patient benefits, cost-effectiveness, commercialization and adoption of DermTechs products and the market opportunity therefor. These forward-looking statements involve significant risks and uncertainties that could cause the actual results to differ materially from the expected results. Most of these factors are outside of the control of DermTech and are difficult to predict. Factors that may cause such differences include, but are not limited to: (1) the outcome of any legal proceedings that may be instituted against DermTech; (2) DermTechs ability to obtain additional funding to develop and market its products; (3) the existence of favorable or unfavorable clinical guidelines for DermTechs tests; (4) the reimbursement of DermTechs tests by Medicare and private payors; (5) the ability of patients or healthcare providers to obtain coverage of or sufficient reimbursement for DermTechs products; (6) DermTechs ability to grow, manage growth and retain its key employees; (7) changes in applicable laws or regulations; (8) the market adoption and demand for DermTechs products and services together with the possibility that DermTech may be adversely affected by other economic, business, and/or competitive factors; and (9) other risks and uncertainties included in (x) the Risk Factors section of the most recent Annual Report on Form 10-K filed by DermTech with the Securities and Exchange Commission (the SEC), and (y) other documents filed or to be filed by DermTech with the SEC. DermTech cautions that the foregoing list of factors is not exclusive. You should not place undue reliance upon any forward-looking statements, which speak only as of the date made. DermTech does not undertake or accept any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements to reflect any change in its expectations or any change in events, conditions, or circumstances on which any such statement is based.

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Akari Therapeutcis (AKTX) Receives FDA Fast Track Designation for Nomacopan for the Treatment of Bullous Pemphigoid


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Akari Therapeutics, Plc (Nasdaq: AKTX), a biopharmaceutical company focused on innovative therapeutics to treat orphan autoimmune and inflammatory diseases where the complement and leukotriene systems are implicated, today announced that the FDA has granted Fast Track designation to nomacopan for the treatment of patients with moderate and severe BP. Nomacopan has also been granted orphan drug designation for nomacopan for the treatment of BP by the FDA and the European Medicines Agency (EMA).

Fast track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The purpose is to get important new drugs to the patient earlier. A drug that receives Fast Track designation benefits from more frequent communications and meetings with the FDA to review the drug’s development plan including the design of the proposed clinical trials, use of biomarkers and the extent of data needed for approval.

Success in BP could potentially open up a range of other severe dermatological conditions for treatment with nomacopan where C5 and LTB4 are implicated, including hidradenitis suppurativa, epidermolysis bullosa acquisita and mucous membrane pemphigoid.

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Other news to note for April 28, 2021 | 2021-04-28

The Allen Institute and Biomarin Pharmaceutical Inc., of San Rafael, Calif., said they formed a collaboration that will use technologies developed at Allen to create gene therapies to treat rare genetic diseases of the central nervous system. The licensed technology was developed by researchers at the Allen Institute for Brain Science with the goal of studying and classifying individual brain cell types by engineering AAVs to carry genes that switch on in specific types of neurons or other cells in the brain. A key component of the engineered AAVs is a molecular “Zip code,” or enhancer, that ensures gene expression is restricted to the correct cellular address. Biomarin will receive an exclusive license to each program for research, development and commercialization. Financial terms were not disclosed.

Cannabics Pharmaceuticals Inc., of Tel Aviv, Israel, disclosed plans to develop a melanoma treatment, which produced antitumor activity on melanoma cell lines. Cannabics plans to start in vivo studies in animal models of melanoma.

Dermtech Inc., of La Jolla, Calif., said it will collaborate with researchers from the Stanford University School of Medicine, led by principal investigator Kavita Sarin, on a study of longitudinal non-invasive cytokine monitoring in people with hidradenitis suppurativa, a chronic skin condition characterized by recurrent swollen and painful lesions in the armpit, groin, anal and breast regions. The three-year study will use Dermtech’s non-invasive sample collection and precision genomics platform to identify and evaluate biomarkers over time in people with the condition, potentially leading to improved decisions about treatment.

Eli Lilly and Co., of Indianapolis, said its development program for mirikizumab will focus exclusively on Crohn’s disease and the ulcerative colitis, an indication where the company reported in March 2021 that the phase III Lucent-1 study met its primary endpoint of clinical remission and all key secondary endpoints. Although the Oasis program in psoriasis generated positive results, with safety and efficacy similar to other IL-23p19 inhibitors, Lilly said in its quarterly earnings update that it does not plan to submit any applications for mirikizumab in the indication.

Essa Pharmaceuticals Inc., of Houston, said it formed a trial collaboration and supply agreement with Bayer AG, of Leverkusen, Germany, to evaluate Essa’s lead candidate, EPI-7386, an N-terminal domain androgen receptor inhibitor, in combination with Bayer’s androgen receptor inhibitor, darolutamide, in people with metastatic castration-resistant prostate cancer. The agreement allows Bayer to sponsor and conduct a phase I/II study, expected to begin in 2021, to evaluate the combination. Essa will supply EPI-7386 for the trial and retain rights to the agent.

Grifols SA, of Barcelona, said it signed an agreement with the government of Andorra to establish a global hub in the tiny country. The facility, the Pyrenees Immunology Research Center, will focus on developing treatments for immune system disorders that can result in diseases including autoimmunity disorders, cancer and emerging infectious diseases. It will also host and sponsor conferences, symposiums and educational programming to promote broader awareness of immunological pathologies. Completion is set for 2023.

Homology Medicines Inc., of Bedford, Mass., said preclinical data demonstrated that its AAVHSCs delivered vectors at a high efficiency to the liver and secreted antibodies throughout the body, resulting in sustained expression levels consistent with C5 antibody therapeutics in a humanized murine model. The proof of concept unlocks potential for a one-time treatment that leverages the liver to produce fully functional antibodies, the company said. The data also demonstrated that its AAVHSCs efficiently transduced the liver and reached relevant tissues, including crossing the blood-brain and peripheral-nerve barriers with one I.V. administration, the company added.

Preclinical data from Neuraly Inc., of Germantown, Md., showed that NLY-01, an engineered exendin-4, glucagon-like peptide-1 receptor (GLP-1R) agonist, can selectively block β-amyloid-induced activation of microglia through up-regulated GLP-1R, inhibit formation of reactive astrocytes and preserve neuronal viability, resulting in improved spatial learning and memory. NLY-01 is entering a phase IIb trial in Alzheimer’s disease while also being evaluated in a phase II Parkinson’s disease trial.

New results of a study of OK-201 from Okyo Pharma Ltd., of London and Boston, showed the non-opioid analgesic candidate, delivered topically in a mouse neuropathic corneal pain model, demonstrated potential to treat acute and chronic ocular pain. The reduced corneal pain response was similar to that of gabapentin, a commonly used oral drug for neuropathic pain, the company added. OK-201 is a lipidated cyclized bovine adrenal medulla analogue.

Pfizer Inc., of New York, said it acquired privately held San Diego-based Amplyx Pharmaceuticals Inc., whose lead compound fosmanogepix, APX-001, is being developed to treat invasive fungal infections. Financial terms were not disclosed. Fosmanogepix is in phase II trials evaluating the safety and efficacy of intravenous and oral formulations to treat life-threatening invasive fungal infections caused by molds, yeasts and rare molds such as Aspergillus spp, Candida spp including Candida auris, Fusarium spp and Scedosporium spp.

Point Biopharma Inc., of Indianapolis, said the U.S. Nuclear Regulatory Commission issued a materials license for a new production facility in Indianapolis. Point is renovating its 80,000-square-foot radiopharmaceutical manufacturing center which, when complete, will make it one of the largest, GMP radioligand manufacturing facilities in the world, the company said. The materials license authorizes handling of nuclear material in chemical and/or physical form, enabling Point to work with a variety of radioisotopes on site plus complete testing and qualification of its operations. The company said it expects the facility will begin to provide supply for its phase III trial targeting metastatic castration-resistant prostate cancer later in 2021.

Silence Therapeutics plc, of London, achieved a research milestone as part of its ongoing RNAi collaboration with Mallinckrodt plc, of Dublin, for complement-mediated diseases, triggering a further $2 million payment to Silence. The milestone relates to preclinical development work on the SLN-500 C3 targeting program, highlighting the successful ongoing collaboration between the two companies. Silence continues to work with Mallinckrodt to progress IND-enabling studies for SLN-501, the first nominated product candidate.

Soligenix Inc., of Princeton, N.J., said preclinical data presented at the annual Conference on Vaccinology Research demonstrated the potency of the Civax COVID-19 vaccine development program in mice and nonhuman primates. Utilizing its heat-stabilization technology, in conjunction with a clinically tested adjuvant (Covaccine HT), Soligenix and its collaborators at the University of Hawaii at Manoa are developing a heat-stable subunit vaccine, targeted to enable ambient shipping and storage.

Triplet Therapeutics Inc., of Cambridge, Mass., disclosed preclinical data in Huntington’s disease (HD) for its first clinical candidate, TTX-3360, including the therapeutic target and route of administration, in a virtual presentation at the CHDI Foundation’s 16th annual HD Therapeutics Conference. TTX-3360, an antisense oligonucleotide, is the first therapeutic candidate with the potential to modify the course of HD and other repeat expansion disorders by targeting the DNA damage response pathway.

Twist Bioscience Corp., of South San Francisco, and Vivlion GmbH, of Frankfurt, Germany, disclosed a collaboration for the generation of gRNA libraries for CRISPR applications. Vivlion will purchase Twist Oligo Pools to generate and sell precision CRISPR libraries for functional genomics research. Vivlion’s 3Cs technology bypasses standard cloning methods such as PCR amplification, allowing direct conversion of Twist’s Oligo Pools into gRNA libraries that maintain Twist’s uniformity.

VBI Vaccines Inc., of Cambridge, Mass., said preclinical data of its enveloped virus-like particle vaccine candidate, VBI-2902, has been submitted for peer-review to a scientific journal and will be available on the online preprint server bioRxiv. The data demonstrate that the candidate expressing a modified, prefusion form of the SARS-CoV-2 spike protein elicited a highly potent and focused neutralizing antibody response, and conferred protective benefit in Syrian golden hamsters challenged with COVID-19, assessed in terms of clinical disease (loss of body weight) and lung inflammation.

Vifor Pharma Group, of St. Gallen, Switzerland, said the first patient has been enrolled in the large scale registry CARE-HK in HF (cardiovascular and renal treatment in heart failure [HF] patients with or at high risk for hyperkalemia [HK]). The non-interventional clinical study aims to better understand renin-angiotensin-aldosterone system inhibitors treatment decisions in clinical practice, potential barriers to achieving optimal guideline-directed care in HF patients with or at high risk for HK, and to assess how Vifor’s Veltassa (patiromer) may be used in the management of this patient population.

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