After a poor showing of its COVID med vilobelimab in a rare skin disorder trial, German drugmaker InflaRx is going back to the drawing board.
The independent data monitoring committee assessing a phase 3 trial of vilobelimab in pyoderma gangrenosum (PG) has urged InflaRx to stop the study early for futility. The committee made the call after analyzing data on the first 30 patients enrolled in the study, InflaRx said in a Wednesday press release. InflaRx noted that it remains blinded to the study results.
Given the trial’s outcome, InflaRx plans to stop development of vilobelimab in PG, though the drug will remain available in the U.S. under emergency use authorization to treat critically ill COVID patients, the company clarified.
Vilobelimab—which goes by the commercial moniker Gohibic in its authorized COVID indication—is a monoclonal antibody designed to block the immune complement factor C5a, which has been implicated in many different inflammatory diseases.
PG is a rare skin condition that causes large, painful sores to form on the skin, most often on the legs. While the exact cause of PG remains elusive, it is believed to be an immune disorder, the Mayo Clinic notes.
“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,” Niels Riedemann, InflaRx’s chief executive, said in a statement.
The company now aims to focus its resources on its oral small molecule candidate INF904—also a C5a inhibitor—which is expected to deliver phase 2a readouts in chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) this summer, InflaRx said.
Meanwhile, the trial winddown may herald the start of a broader cost-saving effort at the company, InflaRx warned. The drugmaker said it is considering a potential “redirection of resources” to help extend its cash runway.
The FDA awarded emergency use authorization to vilobelimab, A.K.A. Gohibic, in April 2023, though the data that supported that sign-off were less-than-ideal.
In a randomized late-stage trial, Gohibic failed to deliver statistically significant results on the study’s primary endpoint of curbing the risk of death in the sickest COVID patients. That said, a separate predefined analysis and two post hoc analyses painted the drug in a better light, showing an improvement that was statistically significant.
In the U.S., the antibody is specifically cleared for use in hospitalized patients within 48 hours of receiving invasive mechanical ventilation (IMV) or extracorporeal membrane oxygenation (ECMO). InflaRx noted that it will carry on with a BARDA-funded phase 2 study of Gohibic as a potential treatment for acute respiratory distress syndrome (ARDS).
Gohibic has also won marketing authorization under exceptional circumstances in the European Union—a distinction not entirely dissimilar to an FDA emergency use nod—to treat adults with SARS-CoV-2-induced ARDS who are on systemic corticosteroids and receiving IMV with or without ECMO.
After the trial update, InflaRx’s share price was down more than 50% in Wednesday morning trading.