See Why Did InflaRx Pause Late-Stage Vilobelimab Trial In Chronic Skin Condition

InflaRx N.V. 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.