お知らせ • Nov 11
InflaRx N.V. Reports Positive Phase 2a Data for INF904 in Hidradenitis Suppurative (HS) and Chronic Spontaneous Urticaria (CSU)
InflaRx N.V. announced positive topline data from a Phase 2a basket study exploring INF904 in HS and CSU. Efficacy data were reported from 29 of 31 HS patients and from 30 of 31 CSU patients. The study is evaluating the safety and pharmacokinetics /pharmacodynamics profile of INF904, with efficacy measures evaluated as exploratory endpoints. InflaRx believes these data provide strong rationale for further development in both indications. The Phase 2a study continues toward completion of the 4-week post-treatment observation period, with the final results targeted for release at major scientific meetings. In addition, InflaRx intends to host a Capital Markets Event showcasing the promise of INF904 in the near future. The Phase 2a trial is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment, with an additional 4-week follow-up period during which time patients are not dosed with INF904 (trial is 8 weeks total). The efficacy data reported are from 29 patients from all three HS dosing cohorts who completed all 4 weeks of treatment (10 patients on 60 mg BID, 11 patients on 90 mg BID, and 8 patients on 120 mg BID), with additional data from patients (n=25) who to-date, have also completed the subsequent 4-week follow-up observation period off drug. In HS, clinical endpoints included reduction in AN and dT counts, achievement of HiSCR, pain reduction (Numeric Rating Scale 30 (NRS30)) and improvement in Dermatology Life Quality Index (DLQI).Across all dosing groups, INF904 induced rapid, meaningful and consistent reductions in ANs and dTs; in addition to improvements in measures such as HiSCR, IHS4, NRS30, and DLQI. Improvements in reported efficacy measures were largely rapid and consistent, beginning from Week 1, and deepened over the 4-week treatment period. All doses showed positive clinical activity and appeared strongest in the highest dosing cohort. The company believes efficacy data for INF904 at 4 weeks are largely in line with data reported for the same timepoint from clinical studies for approved HS therapies and compared favorably for reductions in dT and improvement in NRS30 response. Furthermore, initial data reported from 25 HS patients who completed the 4-week off-drug follow-up period showed that HiSCR responses continued to deepen 4 weeks after the treatment period. Preliminary PK results from Week 8 indicate INF904 levels 4 weeks off drug may still offer C5aR blocking potential. In addition, InflaRx believes inhibiting C5aR may drive an improvement in the inflammatory environment which may confer longer lasting benefit. Safety data from 33 HS patients were reported. No signal of safety concern was detected, with no reported serious adverse events (SAEs) and three adverse events in two patients reported as possibly-to-likely related to drug which all were mild (Grade 1) in nature. Overall, InflaRx believes these data are strong evidence that INF904 is highly active in HS, with improvements in efficacy measures largely differentiated from historically reported placebo, and in line with reported improvements at the 4-week time point for therapies which have successfully completed Phase 3 trials or received approval. Given this positive biologic-like emerging clinical profile, with rapid, consistent and significant reductions in all lesion counts, total inflammatory burden (TIB), and patient reported outcomes (in particular NRS30 Skin Pain), as well as an addressable market for INF904 that InflaRx believes could well exceed $1 billion, the Company has a goal of progressing clinical development into a Phase 2b trial in 2026. The Phase 2a trial is a multi-center, open-label study evaluating multiple INF904 dosing regimens over 4 weeks of treatment, with an additional 4-week follow-up period during which time patients are not dosed with INF904 (trial is 8 weeks total). The efficacy data reported are from 30 patients (14 patients on 60 mg BID and 16 patients on 120 mg BID) that completed all 4 weeks of treatment, with additional data from patients (n=23) who to-date, have also completed the subsequent 4-week follow-up observation period off drug. In CSU, clinical endpoints included change from baseline in UAS7, UCT7 and responder rate analyses, with additional subset analyses conducted in several study subpopulations. Reported improvements in clinical measures such as UAS7 appeared generally higher in the 60 mg dosing cohort (UAS7 change from baseline of -13.7 points at Week 4) and indicate a level of activity that exceeds average historically reported placebo levels and is within the range of existing approved CSU therapies. Furthermore, in patients with severe CSU at baseline (UAS7 of 28–42, n=23), the 60mg dose reduced UAS7 by 15.4 points, and in patients who presented with angioedema (n=3) the reduction of UAS7 was 18.7 points. Additional efficacy analyses in patients with high IgE (n=22) and low IgE (n=6) at baseline showed that INF904 appeared equally effective in both patient populations. Furthermore, initial data reported from 23 CSU patients who completed the 4-week off-drug observational follow-up period, indicated that patients continued to benefit from INF904 four weeks after the last dose, with responses in the 60mg dosing cohort showing a mean absolute UAS7 reduction of 16.7 points. InflaRx believes that INF904’s ability to drive durable improvements within the inflammatory environment could provide deepened clinical benefit with long-term dosing.Safety data from 33 CSU patients were reported. No signal of safety concern was detected, with no reported SAEs and one adverse event reported as possibly related to drug which was mild (Grade 1) in nature. Overall, InflaRx believes these data suggest that INF904 is active in CSU and not only differentiated from reported historical placebo rates, but potentially within the range of currently approved CSU therapies. These data further indicate that UAS7 decreases may deepen with longer-term treatment. Given this positive emerging clinical profile, and an addressable market for INF904 that InflaRx believes could well exceed $1 billion, the Company is targeting further development for INF904 in CSU via its active engagement with potential partners.