InflaRx (IFRX) Status Update summary

Key clinical results and efficacy

• INF904, an oral C5aR1 antagonist, demonstrated best-in-class potential with high tissue penetration, superior PK/PD profile, and tenfold higher exposure than Avacopan at the same dose in phase I data.

• In hidradenitis suppurativa (HS), 29 patients completed four weeks of treatment, with the high dose (120 mg) group showing the greatest reduction in abscess and nodule (AN) counts and total inflammatory burden.

• High dose INF904 led to rapid, consistent reductions in AN counts, draining tunnels, and pain scores, with half of high dose patients tunnel-free at week four and pain scores reduced by over 75%.

• HiSCR50 response rates and pain score reductions deepened after drug cessation, reaching 63% in the high dose group at week eight, with continued active drug levels above IC50.

• Dermatology Life Quality Index (DLQI) improvements were substantial, especially at higher doses, and efficacy trends deepened at week 8 follow-up.

Chronic spontaneous urticaria (CSU) efficacy results

• In CSU, 30 patients completed treatment, with the 60 mg group achieving UAS7 reductions within the range of approved therapies and notable efficacy in severe, angioedema, and both low/high IgE subgroups.

• UAS7 reductions persisted or deepened at week 8, and disease control (UCT7) improved by more than 4 points at week 4 across all doses.

• Both anti-IgE naïve and experienced patients showed meaningful UAS7 reductions.

• No new safety signals were observed in CSU patients.

Safety and tolerability

• Across approximately 180 subjects, no safety concerns or severe adverse events were detected, with only mild grade 1 adverse events reported.

• No patients in the HS study received systemic antibiotics during the trial, and no safety signals emerged in preclinical or clinical studies, including high-dose exposures.

• INF904 showed a favorable safety profile compared to class-related concerns seen with other C5aR inhibitors, such as Avacopan.