InflaRx Ends Lead Asset Development After Failed Study For Rare And Painful Skin Disease

Core Viewpoint - InflaRx N.V. announced the termination of the Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility as recommended by the Independent Data Monitoring Committee (IDMC) [1][2] Group 1: Trial and Development Updates - The IDMC's recommendation was based on an analysis of the first 30 patients, with no unexpected adverse events reported [2] - InflaRx will discontinue further development of vilobelimab for pyoderma gangrenosum and will focus on INF904, with Phase 2a data readouts expected in chronic spontaneous urticaria and hidradenitis suppurativa this summer [2] - The company is considering additional cost savings and resource redirection to extend its cash runway [3] Group 2: Regulatory and Market Status - GOHIBIC (vilobelimab) is still available in the U.S. under Emergency Use Authorization for COVID-19 in hospitalized adults [3] - In the EU, GOHIBIC has received marketing authorization under exceptional circumstances for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome [4] - InflaRx is exploring commercial partnerships and distribution options in the EU without expecting a negative impact on its cash burn rate [4] Group 3: Financial Position - In February, InflaRx completed a public offering of 8.25 million shares at $2.00 per share, raising approximately $30 million in gross proceeds [4] - As of March 31, 2025, the company reported cash, cash equivalents, and marketable securities totaling €65.7 million, indicating sufficient funds for planned operations into 2027 [7] Group 4: Stock Performance - Following the announcement, IFRX stock experienced a significant decline of 52.8%, trading at $0.86 during the premarket session [5]