InflaRx Announces First Patient Dosed in Phase III Trial with Vilobelimab in Pyoderma Gangrenosum

• Multi-national, randomized, controlled adaptive Phase III study in ulcerative pyoderma gangrenosum (PG) initiated and first patient dosed in the U.S.
• PG is a rare and debilitating autoimmune skin disease characterized by painful ulcers that can rapidly progress

JENA, Germany, Nov. 06, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today that the first patient has been dosed in its Phase III study investigating the efficacy and safety of vilobelimab in ulcerative PG, a rare neutrophilic and inflammatory skin disease characterized by destructive, painful cutaneous ulcers.

“We are pleased that the first patient has been dosed in the U.S. in our pivotal Phase III study with vilobelimab for the treatment of ulcerative pyoderma gangrenosum. There are currently no approved treatments for this debilitating disease in either the U.S. or Europe, and therefore, there remains a high unmet medical need for these patients,” said Dr. Camilla Chong, MD, Chief Medical Officer of InflaRx. “The Phase III study builds on our promising Phase II clinical results, and we look forward to the continual collaboration with external experts with the ultimate goal of helping patients that are suffering from this devastating condition.”

The Phase III clinical study is designed to enroll patients worldwide, including countries such as the U.S., countries in Europe, and Australia. The multi-national, randomized, double-blind, placebo-controlled trial has two arms: one arm receiving vilobelimab (2400mg every other week) plus a low dose of corticosteroids and another arm receiving placebo plus the same low dose of corticosteroids. In both arms, corticosteroid treatment will be initiated on day 1 and will be tapered off within the first 8 weeks of the trial. The primary endpoint of the study is complete closure of the target ulcer at any time up to 26 weeks after initiation of treatment.

The study has an adaptive trial design with an interim analysis blinded for the sponsor and investigators (but unblinded for the independent data safety monitoring committee), which is planned upon enrollment of approximately 30 patients, divided equally between the two aforementioned arms of the study. The interim analysis with a set of predefined rules will take into account the then-observed difference in complete target ulcer closure between the two arms and will then determine whether the trial sample size will be adapted or whether the trial should be stopped due to futility. The enrollment period is projected to last at least two years, and its overall period will depend on the total trial size after sample size adaptation.