- InflaRx N.V. (NASDAQ:IFRX) provided a development update for its monoclonal anti-C5a antibody, vilobelimab, in pyoderma gangrenosum (PG) and severe COVID-19.
- The FDA and the European Medicines Agency (EMA) have granted orphan drug designation to vilobelimab for PG.
- PG is a rare condition that causes large, painful sores (ulcers) to develop on the skin.
- In addition, the company had a productive FDA end-of-phase II meeting to its plans for a Phase 3 development program in PG.
- The FDA indicated its support for a randomized, controlled Phase 3 study and offered to review the study protocol.
- Based on the agency's feedback and recommendations, InflaRx is now finalizing the design for a Phase 3 trial.
- InflaRx requested a meeting with the FDA to obtain guidance for a potential emergency use authorization submission of vilobelimab in COVID-19 patients.
- Related: InflaRx Shares Plunge After Disappointing Results On Vilobelimab In Critically Ill COVID-19 Patients.
- This has been scheduled as a Type B meeting for early Q3. In addition, the company is in ongoing dialogue with the EMA about the next steps in developing vilobelimab in mechanically ventilated severe COVID-19 patients.
- Price Action: IFRX shares were down 6.91% at $1.42 during the market session on the last check Wednesday.
