- InflaRx N.V. (NASDAQ:IFRX) announced topline data from Phase 3 part of Phase 2/3 PANAMO study of vilobelimab in critically ill COVID-19 patients.
- Vilobelimab in mechanically ventilated COVID-19 patients showed a relative reduction in 28-day all-cause mortality of 23.9% (vilobelimab 31.7% versus placebo 41.6%), which was not statistically significant (p=0.094).
- At the recommendation of regulatory authorities, during the trial, the Company changed the statistical analysis method for the primary endpoint.
- The original protocol specified a non-stratified Cox regression analysis that would have resulted in a p-value of 0.027 (statistically significant), the Company said.
- Also Read: FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease.
- A pre-specified analysis of patients from Western European countries (n=209) showed a relative reduction in 28-day all-cause mortality of 43% (vilobelimab 21.2% versus placebo 37.2%).
- The Company plans to discuss the data with regulatory authorities to determine potential next steps in developing vilobelimab for this indication.
- Sixty-day all-cause mortality, a key secondary endpoint, showed a continued reduction of mortality in the vilobelimab arm (36.5% vilobelimab versus 47.2% placebo.
- In this study, vilobelimab appeared to be safe and well-tolerated.
- Price Action: IFRX shares are down 16.8% at $1.99 during the market session on the last check Thursday.
