On Wednesday, InflaRx N.V. announced that the Independent Data Monitoring Committee (IDMC) recommended stopping the Phase 3 trial of vilobelimab in treating pyoderma gangrenosum (PG). This decision followed an unblinded interim analysis which found the trial unlikely to meet its goals, a conclusion known as futility.
Pyoderma gangrenosum is a rare, chronic skin disease that causes painful, necrotic ulcers, often on the legs. The IDMC reviewed data from the first 30 patients in the study and did not report any unexpected safety issues.
InflaRx, which sponsors the trial, remains blinded to the detailed results. The company plans to halt further development of vilobelimab for PG. Instead, it will focus its resources on INF904, a drug currently in Phase 2a trials for chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), with data expected this summer.
The company is also exploring additional cost-saving measures to extend its financial runway.
Vilobelimab, marketed as GOHIBIC in the U.S., remains available under Emergency Use Authorization (EUA) by the Food and Drug Administration (FDA). It is approved for treating COVID-19 in hospitalized adults requiring invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO) if given within 48 hours of treatment start.
InflaRx continues to support a BARDA-funded Phase 2 clinical study involving vilobelimab.
In Europe, GOHIBIC has marketing authorization under exceptional circumstances for treating adults with COVID-19-related acute respiratory distress syndrome (ARDS) who are on systemic corticosteroids and IMV with or without ECMO. The company is considering commercial partnerships and distribution options in the EU. It does not expect these moves to increase its cash burn rate.
In February 2025, InflaRx raised approximately $30 million in gross proceeds through a public offering of 8.25 million shares and pre-funded warrants to buy 6.75 million additional shares at $2.00 each.
As of March 31, 2025, InflaRx held 65.7 million euros in cash, equivalents, and marketable securities, including funds from the recent offering. The company expects its current cash to support operations through 2027.
Following the announcement, InflaRx stock fell 52.8% to $0.86 in premarket trading on Wednesday.
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