InflaRx's Vilobelimab Shows Encouraging Signs Of Drug Activity In Mid-Stage Study With Dermatological Ulcer Patients

InflaRx N.V. IFRX has announced data from the first 10 evaluable patients in the ongoing Phase 2a open-label study with vilobelimab in Pyoderma Gangraenosum (PG).
PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin, most often on the legs.
Over a treatment period of 26 weeks (until day 189), patients were treated biweekly with vilobelimab 800mg, 1600mg, or 2400mg, after an initial run-in phase with three doses of 800mg on days 1, 4, and 8.
Out of the 10 patients evaluated for efficacy at day 99, four patients met the response criteria, with three achieving complete closure of the target ulcer.
The third patient demonstrating complete target ulcer closure had been increased from the 1600mg dose group to the highest dose of 2400mg on day 57 of the study and closed the ulcer after the dose escalation.
According to the PGA definition, the other six patients all showed a slight improvement in their condition (PGA score = 4).
Overall, vilobelimab was well-tolerated, and no new safety findings emerged. One patient experienced a delayed hypersensitivity in the form of a skin rash which resolved upon discontinuation of vilobelimab.
Vilobelimab is a first-in-class monoclonal anti-human complement factor C5a antibody.
Price Action: IFRX shares are up 2.27% at $2.70 during the premarket session on the last check Tuesday.