FDA Issues Corrected Advice To InflaRx's Vilobelimab Study In Skin Disease

InflaRx N.V. IFRX has received a corrected advice letter from the FDA regarding its Phase 3 vilobelimab program for hidradenitis suppurativa (HS). 

• In this corrected letter, FDA no longer recommends that the Company use the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint.
• But gives recommendations related to implementing the modified HiSCR (m-HiSCR). 
• In February, the written advice letter stated that the Agency recommended using the HiSCR as the primary endpoint in the Phase III trial, which was inconsistent with the minutes from a Type A advice meeting held between InflaRx the FDA.
• After the corrected advice, InflaRx believes that further development in HS is feasible. 
• InflaRx is currently evaluating its strategic options on developing vilobelimab in this disease space most efficiently.
• The Company plans to update on its pipeline development strategy in Q2 of 2022.
• Price Action: IFRX shares are up 9.17% at $2.38 during the market session on the last check Thursday.