AUSTIN, Texas, Jan. 28, 2019 (GLOBE NEWSWIRE) — XBiotech (NASDAQ: XBIT) announced today that Dr. Alice Gottlieb, M.D., Ph.D., will be giving the presentation “Bermekimab Shows Efficacy for Treating Hidradenitis Suppurativa (HS), Including Marked Reduction in Pain” during the afternoon session on March 2nd, 2019 at the AAD annual meeting being held at the Walter E. Washington Convention Center in Washington, D.C. The presentation, which was accepted as “late-breaking research: clinical trials,” will provide details of the Company’s recent Phase II clinical trial results in 42 HS patients that received 400mg subcutaneous weekly doses of bermekimab in a 12-week treatment regimen.
The study involved two treatment groups of subjects: those who had failed prior anti-TNF therapy (n=24); and those with no prior anti-TNF treatment history (n=18). The study was conducted at eleven different dermatology research centers across the U.S.
The study’s Chair, Dr. Alice Gottlieb, M.D., Ph.D., Clinical Professor of Dermatology, Department of Dermatology, Icahn School of Medicine at Mount Sinai, NY, NY, commented, “I am looking forward to presenting these very exciting results for a new drug that can help address a significant unmet need for patients suffering from hidradenitis suppurativa.”
A major finding in the study was a significant treatment-related reduction of pain in the HS patients. Pain is widely recognized among experts as a key objective for HS treatment, but this symptom has been largely unaddressed by available approved therapies. No approved monotherapy for HS has shown a significant effect on pain1.
Hidradenitis Suppurativa (HS) is a chronic, inflammatory skin disorder affecting areas rich in apocrine glands. Nodules appear in the affected areas and progressively become swollen with spontaneous rupture and release of pus. This process occurs repeatedly leading to formation of deep sinus tracts and painful dermal abscesses2,3. Pain is a paramount condition in patients suffering from HS, as this chronic inflammation and accompanying pain account for the fact that HS is ranked first among skin disorders in terms of adversely affecting quality of life4. The global prevalence for HS is estimated at up to 4% of the population3.
About True Human™ Therapeutic AntibodiesXBiotech’s True Human™ antibodies are derived without modification from individuals who possess natural immunity to certain diseases. With discovery and clinical programs across multiple disease areas, XBiotech’s True Human antibodies have the potential to harness the body’s natural immunity to fight disease with increased safety, efficacy and tolerability.
About XBiotech XBiotech is a fully integrated global biosciences company dedicated to pioneering the discovery, development and commercialization of therapeutic antibodies based on its True Human™ proprietary technology. XBiotech currently is advancing a robust pipeline of antibody therapies to redefine the standards of care in oncology, inflammatory conditions and infectious diseases. Headquartered in Austin, Texas, XBiotech also is leading the development of innovative biotech manufacturing technologies designed to more rapidly, cost-effectively and flexibly produce new therapies urgently needed by patients worldwide. For more information, visit www.xbiotech.com.
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1 Only 34 of 122 (28%) of patients treated weekly with adalimumab achieved this endpoint at week 12 in the PIONEER I monotherapy study.2 Revuz J. Hidradenitis suppurativa. J Eur Acad Dermatol Venereol 2009; 23: 985-998.3 Alikhan A, Lynch PJ, Eisen DB. Hidradenitis suppurativa: a comprehensive review. J Am Acad Dermatol. 2009 Apr;60(4):539-61; quiz 562-3. doi: 10.1016/j.jaad.2008.11.911.4 Canoui-Poitrine F, Revuz JE, Wolkenstein P, Viallette C, Gabison G, Pouget F, et al. Clinical characteristics of a series of 302 French patients with hidradenitis suppurativa, with an analysis of factors associated with disease severity. J Am Acad Dermatol 2009; 61: 51-57.