- InflaRx N.V. (NASDAQ:IFRX) has received an advice letter from the FDA about the vilobelimab Phase 3 program for hidradenitis suppurativa (HS), a condition that causes small, painful lumps to form under the skin.
- The feedback recommends using the Hidradenitis Suppurativa Clinical Response Score (HiSCR) as the primary endpoint in the Phase 3 trial, which contrasts the advice provided in a Type A meeting held in Q3 2021.
- The agency provided advice on the modified HiSCR, a new primary endpoint suggested by the Company, that would measure the reduction of all three types of inflammatory lesions in HS – inflammatory nodules, abscesses, and draining tunnels.
- The HiSCR does not capture a reduction in draining tunnels. The FDA did not recommend the traditional HiSCR as the primary endpoint measure within the Type A written response.
- Related: InflaRx's Vilobelimab Shows Encouraging Action Against Rare Autoimmune Disorder.
- Following the advice, InflaRx initiated a Phase III trial designed to study patients with moderate to severe HS disease suffering from actively draining tunnels.
- Given the unexpected details of the feedback from the FDA, InflaRx will pause activities related to the Phase 3 trial. The Company will seek to clarify the advice received and determine the next steps.
- Price Action: IFRX shares are down 14.30% at $2.58 during the market session on the last check Monday.
