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JENA, Germany - InflaRx N.V. (NASDAQ:IFRX) announced Monday that its oral C5a receptor inhibitor INF904 demonstrated positive results in a Phase 2a study for hidradenitis suppurativa (HS) and chronic spontaneous urticaria (CSU). The clinical-stage biopharmaceutical company, currently trading at $1.23 with a market cap of $83.33 million, has seen its shares drop 10.87% over the past week despite these positive developments.
The study evaluated multiple dosing regimens of INF904 over a four-week treatment period with an additional four-week follow-up. Data were reported from 29 HS patients and 30 CSU patients who completed the treatment phase.
In HS patients, INF904 showed rapid and consistent reductions in abscesses, nodules, and draining tunnels across all dosing groups, with the strongest effects observed in the highest dosing cohort (120 mg twice daily). The HiSCR50 response rate, measuring at least 50% reduction in inflammatory lesions, was 28% at week 4 and increased to 44% at week 8, four weeks after treatment ended.
For CSU patients, the 60 mg twice daily dose reduced the 7-day Urticaria Activity Score (UAS7) by 13.7 points at week 4, with improvements continuing to 16.3 points four weeks after treatment cessation. Patients with severe CSU showed a 15.4-point reduction in UAS7.
No serious adverse events were reported in either patient group. The company reported only three mild adverse events possibly related to the drug in HS patients and one in CSU patients.
"These data represent a pivotal moment for the company, underscoring the therapeutic promise of INF904 as a pipeline-in-a-product," said Prof. Niels C. Riedemann, CEO and Founder of InflaRx, in a press release statement.
InflaRx plans to initiate a Phase 2b trial for INF904 in HS in 2026 and is exploring partnership opportunities to advance development in CSU and other inflammatory disorders.
The Phase 2a study continues with the completion of the post-treatment observation period, with final results expected to be presented at upcoming scientific meetings.
In other recent news, InflaRx N.V. is set to release its third-quarter 2025 financial results and topline data from its Phase 2a clinical trial of INF904 on November 10, 2025. The company will also host a webcast and conference call on the same day to discuss these clinical results. Additionally, InflaRx has regained compliance with Nasdaq's minimum bid price requirement, having maintained a closing bid price at or above $1.00 for ten consecutive business days. In a positive development for the company, H.C. Wainwright has assumed coverage on InflaRx with a Buy rating and set a price target of $6.00. The firm's analysis highlighted InflaRx's lead assets, vilobelimab and INF904, as key factors in their evaluation. These recent developments provide a comprehensive view of InflaRx's current activities and future prospects.
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