InflaRx’s vilobelimab met the bar for futility in a Phase III trial for the rare skin disease pyoderma gangrenosum.
InflaRx will no longer move forward with the Phase III trial of its investigational antibody vilobelimab for the treatment of pyoderma gangrenosum, the biotech announced on Wednesday.
The decision follows the recommendation of an independent data monitoring board, which reviewed early unblinded data from the late-stage trial and determined that moving forward would be futile. The data committee did not find any new safety signals of concern. InflaRx remains blinded to the study findings.
Pyoderma gangrenosum (PG) is a rare and chronic skin disease characterized by painful ulcers commonly occurring on the legs but that can also be spread throughout the body. It is not clear what causes PG, though it is thought that immune dysregulation plays a role in its pathology. Patients with PG also typically suffer from other immune-mediated conditions such as rheumatoid arthritis, ulcerative colitis and Crohn’s disease.
InflaRx’s proposed answer to PG was vilobelimab, a chimeric IgG4-kappa antibody that targets the C5a protein, a key player in the complement cascade. Through this mechanism, vilobelimab theoretically tamps down inflammation, including various associated processes such as coagulation and immune cell activation.
In April 2023, the FDA granted vilobelimab emergency use authorization for COVID-19 in hospitalized adults who are on invasive mechanical ventilation or artificial life support. Vilobelimab, carrying the brand name Gohibic for this indication, remains on the FDA’s list of biologics approved for emergency use in COVID-19, but otherwise remains “investigational,” as per InflaRx’s Wednesday release.
Gohibic “has not been approved by the FDA for any indication, including for the treatment of COVID-19,” the biotech added.
After discontinuing the PG program for vilobelimab, InflaRx will now focus its resources on its oral C5aR1 blocker INF904, which the company is testing for chronic spontaneous urticaria and hidradenitis suppurativa. Phase IIa data in these indications are anticipated this summer, according to Wednesday’s release, though the company did not specify which month.
The late-stage stumble could trigger a strategic reorientation for InflaRx, which on Wednesday said it is “considering additional cost savings and redirection of resources toward the goal of extending the Company’s existing cash runway.”
In its first-quarter 2025 earnings report earlier this month, InflaRx absorbed a net loss of €8.3 million, or around $9.4 million. As of March 31, the biotech had roughly €65.7 million ($74.4 million) in cash, cash equivalents and marketable securities.
