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 and chronic skin disease. The decision comes after an independent data monitoring committee recommended halting the study due to futility, dealing a significant blow to the company's development pipeline.

Vilobelimab Trial Halted After Disappointing Results

The late-stage trial for vilobelimab, a chimeric IgG4-kappa antibody targeting the C5a protein, was stopped following an analysis of data from the first 30 enrolled patients. InflaRx remains blinded to the study findings, but the independent committee found no new safety concerns associated with the treatment.

Niels Riedemann, InflaRx's chief executive, 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."

Pyoderma gangrenosum is characterized by painful ulcers, typically occurring on the legs but potentially spreading throughout the body. The exact cause of PG is unknown, though immune dysregulation is thought to play a significant role in its pathology.

Reprioritization of Research Pipeline and Financial Considerations

Following this setback, InflaRx is redirecting its resources towards the development of INF904, an oral C5aR1 blocker currently in Phase IIa trials for chronic spontaneous urticaria and hidradenitis suppurativa. The company anticipates data readouts from these studies this summer.

The discontinuation of the vilobelimab PG program may trigger a broader strategic reorientation for InflaRx. The company announced it is "considering additional cost savings and redirection of resources toward the goal of extending the Company's existing cash runway." As of March 31, 2025, InflaRx reported approximately €65.7 million ($74.4 million) in cash, cash equivalents, and marketable securities.

Vilobelimab's Future and Emergency Use Authorization

Despite the setback in PG treatment, vilobelimab, marketed as Gohibic, retains its emergency use authorization (EUA) from the FDA for the treatment of COVID-19 in critically ill patients. The antibody is specifically approved for use in hospitalized patients within 48 hours of receiving invasive mechanical ventilation or extracorporeal membrane oxygenation.

InflaRx emphasized that Gohibic "has not been approved by the FDA for any indication, including for the treatment of COVID-19," outside of its EUA status. The company will continue its BARDA-funded Phase II study of Gohibic as a potential treatment for acute respiratory distress syndrome (ARDS).

In the European Union, Gohibic 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.

The news of the trial discontinuation has had a significant impact on InflaRx's stock, with shares down more than 50% in trading following the announcement.