InflaRx announces first patient dosed in Phase III trial

InflaRx N.V. announced 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 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.