InflaRx N.V.(US:IFRX) Globenewswire·2025-11-10 12:30Core Insights - InflaRx N.V. announced positive topline data from a Phase 2a basket study of INF904 for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU), indicating strong efficacy and safety profiles [1][2][19] - The company plans to advance INF904 into Phase 2b trials in HS and expand its clinical program in CSU, highlighting the drug's potential as a "pipeline-in-a-product" [2][11][20] Phase 2a Data in HS - The Phase 2a trial involved 31 HS patients, with efficacy data reported from 29 patients across three dosing cohorts: 60 mg BID, 90 mg BID, and 120 mg BID [3][12] - Key clinical endpoints included reductions in abscesses and nodules (AN), draining tunnels (dT), and improvements in pain and quality of life measures [4][5][10] - INF904 demonstrated rapid and consistent reductions in ANs and dTs, with the highest dosing cohort showing the strongest clinical activity [5][6][10] - Safety data indicated no serious adverse events, with only mild adverse events reported [9][10] Phase 2a Data in CSU - The Phase 2a trial for CSU included 31 patients, with efficacy data reported from 30 patients across 60 mg BID and 120 mg BID dosing cohorts [15][22] - Clinical endpoints included changes in the Urticaria Activity Score (UAS7) and Urticaria Control Test (UCT7), with significant reductions observed, particularly in patients with severe CSU [17][19][22] - Safety data showed no serious adverse events, reinforcing the drug's safety profile [19][22] Market Potential - InflaRx estimates the addressable market for INF904 could exceed $1 billion, emphasizing the need for novel therapies in HS and CSU [11][20] - The company is actively engaging with potential collaborators to expedite development goals for INF904 [6][20] Future Plans - InflaRx aims to complete the 4-week post-treatment observation period and present final results at major scientific meetings [1][22] - A Capital Markets Event is planned to showcase the potential of INF904 [1][2]