InflaRx Discontinues Vilobelimab Study for Rare Skin Disease, Shifts Focus to Oral C5aR1 Blocker

German biopharmaceutical company InflaRx has announced the discontinuation of its Phase III trial for vilobelimab in the treatment of pyoderma gangrenosum (PG), a rare inflammatory skin disorder. The decision comes after an independent data monitoring committee recommended halting the study due to futility, marking a significant setback for the company's rare disease program.

Vilobelimab's PG Trial Halted

InflaRx's vilobelimab, a chimeric IgG4-kappa antibody targeting the C5a protein, failed to demonstrate efficacy in the treatment of pyoderma gangrenosum. The Phase III trial was terminated following an analysis of data from the first 30 enrolled patients, which indicated that continuing the study would be futile. While InflaRx remains blinded to the specific study findings, the data committee reported no new safety concerns associated with the treatment.

Pyoderma gangrenosum, characterized by painful ulcers typically occurring on the legs, is a chronic skin condition often associated with other immune-mediated disorders such as rheumatoid arthritis, ulcerative colitis, and Crohn's disease. The exact cause of PG remains unclear, though immune dysregulation is believed to play a significant role in its pathology.

Strategic Shift and Resource Reallocation

In light of this setback, InflaRx is pivoting its focus to INF904, an oral C5aR1 blocker currently in development for chronic spontaneous urticaria and hidradenitis suppurativa. The company anticipates Phase IIa data for these indications to be available this summer, though specific timing details were not disclosed.

InflaRx CEO Niels Riedemann stated, "While the outcome is not what we had hoped it would be, InflaRx remains committed to its goal of developing new therapies for underserved patients with chronic immune-dermatological conditions."

The company is also considering additional cost-saving measures and resource redirection to extend its existing cash runway. As of March 31, 2025, InflaRx reported approximately €65.7 million ($74.4 million) in cash, cash equivalents, and marketable securities, with a net loss of €8.3 million ($9.4 million) in the first quarter of 2025.

Vilobelimab's Future and Emergency Use Authorization

Despite the disappointment in the PG trial, vilobelimab, marketed under the brand name Gohibic, retains its emergency use authorization (EUA) in the United States for the treatment of COVID-19 in critically ill patients. The antibody is specifically authorized for use in hospitalized adults who are on invasive mechanical ventilation or extracorporeal membrane oxygenation within 48 hours of initiation.

InflaRx emphasized that Gohibic has not received full FDA approval for any indication, including COVID-19 treatment. The company will continue its BARDA-funded Phase II study of Gohibic for acute respiratory distress syndrome (ARDS).

In the European Union, vilobelimab has also received marketing authorization under exceptional circumstances for treating adults with SARS-CoV-2-induced ARDS who are on systemic corticosteroids and receiving invasive mechanical ventilation with or without ECMO.