InflaRx Announces Outcome of Interim Analysis for Vilobelimab Phase 3 Trial in Pyoderma Gangrenosum

Core Viewpoint - InflaRx N.V. announced the discontinuation of the Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility, based on an interim analysis of the first 30 patients, with no unexpected adverse events reported [1][2] Company Overview - InflaRx N.V. is a biopharmaceutical company focused on developing anti-inflammatory therapeutics targeting the complement system, specifically through its proprietary anti-C5a and anti-C5aR technologies [5] - The lead product candidate, vilobelimab, is a first-in-class anti-C5a monoclonal antibody that has shown clinical activity in various studies [5][17] - The company was founded in 2007 and has offices in Jena and Munich, Germany, as well as Ann Arbor, MI, USA [5] Product Development - Following the trial's discontinuation, InflaRx will prioritize resources on INF904, an oral inhibitor of C5aR, with Phase 2a data readouts expected in chronic spontaneous urticaria and hidradenitis suppurativa this summer [2] - The company is also considering cost-saving measures to extend its cash runway [2] Regulatory Status of Vilobelimab - Vilobelimab (GOHIBIC) has received Emergency Use Authorization from the FDA for treating COVID-19 in hospitalized adults when initiated within 48 hours of invasive mechanical ventilation or ECMO [3][7] - In the EU, vilobelimab has been granted marketing authorization under exceptional circumstances for treating adult patients with SARS-CoV-2-induced acute respiratory distress syndrome who are receiving systemic corticosteroids and invasive mechanical ventilation [4][9] Clinical Trial Results - The EU approval of vilobelimab is supported by results from the Phase 3 PANAMO trial, which demonstrated a 23.9% relative reduction in 28-day all-cause mortality compared to placebo in invasively mechanically ventilated COVID-19 patients [9][10]