- InflaRx (IFRX, Financial) halts Phase 3 trial for vilobelimab in pyoderma gangrenosum due to futility.
- Focus shifts to INF904, with Phase 2a data expected this summer in chronic spontaneous urticaria and hidradenitis suppurativa.
- GOHIBIC (vilobelimab) retains Emergency Use Authorization in the US and EU for COVID-19 related indications.
InflaRx N.V. (IFRX), a German-based biopharmaceutical company, announced the discontinuation of its Phase 3 trial for vilobelimab in treating pyoderma gangrenosum due to futility, based on data from the first 30 patients. The Independent Data Monitoring Committee recommended the halt, citing no unexpected adverse events.
The company will discontinue vilobelimab development for pyoderma gangrenosum and redirect its efforts towards INF904, an oral C5aR inhibitor. Phase 2a data readouts for INF904 in chronic spontaneous urticaria and hidradenitis suppurativa are anticipated this summer. InflaRx is also exploring additional cost-saving measures to extend its financial runway.
Despite the setback, vilobelimab remains available under the name GOHIBIC in the United States, where it holds an Emergency Use Authorization by the FDA for the treatment of COVID-19 in hospitalized adults. It is similarly authorized in the European Union for SARS-CoV-2-induced acute respiratory distress syndrome (ARDS) under exceptional circumstances.
As InflaRx navigates this clinical challenge, its strategic shift towards INF904 seeks to leverage potentially more promising therapeutic targets while maintaining critical treatment options for COVID-19 patients through GOHIBIC. The company’s focus on optimizing resources underscores its commitment to developing therapies for chronic immune-dermatological conditions.
