The company also completed a blinded interim analysis into the potential impact of COVID-19 on this European Union study, and concluded the trial could proceed as planned to its second phase, but with fewer enrolled patients.
However, findings in a separate COVID-19 analysis on a similar Phase 2 trial in AAV patients in the U.S., called IXPLORE (NCT03712345), led InflaRx to stop this study and analyze existing data earlier than anticipated.
The company will now “align and streamline” IFX-1’s development program for AAV in the U.S. and EU, it said in a press release.
IFX-1 is a first-in-class antibody designed to target and block the activity of the complement activation C5a protein. This protein is part of the complement system — a set of more than 20 blood proteins that form part of the body’s immune defenses — that is thought to be involved in the overactivation of the immune system in AAV patients.
The European two-part trial, called IXCHANGE (NCT03895801), is assessing the safety and efficacy of IFX-1, compared with a placebo, in adults with active granulomatosis with polyangiitis (GPA) or microscopic polyangiitis (MPA) receiving standard care immunosuppressive therapy, with either rituximab or cyclophosphamide.
During the first part of the study, participants will be randomized to either IFX-1 in combination with a small dose of glucocorticoids, or to a placebo plus a standard dose of glucocorticoids.
Its second part will investigate if the effects of treatment with IFX-1 alone are identical to those obtained when IFX-1 is used alongside glucocorticoids. Trial investigators may be recruiting at sites across Europe; information is available here.
Patient dosing started last year, with top-line findings expected by March 2021.
The company also noted important milestones in other development programs for IFX-1. In its financial report, InflaRx mentioned a meeting scheduled with the FDA for mid-2020 to discuss a concluding Phase 2 study of IFX-1 for hidradenitis suppurativa and its future development of IFX-1 for this skin disorder.
InflaRx also highlighted recently announced promising findings regarding the first five patients dosed in its Phase 2a trial (NCT03971643) of IFX-1 in pyoderma gangraenosum. Early study findings showed that two of the five patients saw their skin ulcers fully healed following treatment with IFX-1.
“InflaRx continues to make progress with its clinical development programs for IFX-1 and recently reported encouraging initial results in pyoderma gangraenosum,” Niels C. Riedemann, CEO and founder of InflaRx, said in the release.
“With the upcoming scheduled FDA End of Phase 2 meeting for development in hidradenitis suppurativa, the company is keeping a strong focus on potentially advancing into Phase 3 development in this disease,” Riedemann added.
More recently, the company launched a Phase 2 trial (NCT04333420) to explore the potential of IFX-1 at treating patients with severe pneumonia associated with COVID-19. Like previous studies, the trial will be divided into two parts, with an interim analysis to determine if it should proceed to a confirmatory phase.
Its first part met its targeted enrollment of 30 patients on April 24.