InflaRx Showcases INF904 at R&D Event

InflaRx N.V., a biopharmaceutical company focusing on anti-inflammatory therapeutics through complement system inhibition, recently held a virtual R&D event to discuss developments regarding its oral small molecule C5aR inhibitor, INF904. The event highlighted the potential of INF904 in treating chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), and further explored its broader applications in inflammation and immunology.

Prominent medical experts such as Prof. Dr. Marcus Maurer, Christopher Sayed, MD, and Prof. Dr. Jörg Köhl participated, offering insights into the drug's promising medical role and differentiation from existing treatments. The company revealed detailed plans for its Phase 2a trials, aiming to initiate these studies by the end of 2024.

The Phase 2a trial will involve 75 patients across various centers and will adopt an open-label approach to evaluate multiple dosing regimens of INF904 over a 4-week treatment period. The objective is to generate additional safety and pharmacokinetic (PK) data while demonstrating meaningful clinical benefits. Patients will be monitored weekly, and outcome measures will cover safety, PK, and preliminary efficacy signs. After the treatment period, follow-up will extend for another 4 weeks. Data from this study are expected in the summer of 2025, followed by the initiation of a larger Phase 2b trial later that year.

In the CSU segment of the trial, patients will be divided into three groups, dosing 45 patients in total. Study Arms 1 and 2 will receive 30 mg and 90 mg of INF904 twice daily (BID), respectively, while Study Arm 3 will involve anti-IgE non-responders dosed at 90 mg BID. Efficacy measures will include changes in the Urticaria Activity Score 7 (UAS7), Hives Severity Score (HSS7), and Itch Severity Score (ISS7) from baseline to the end of week 4. Biomarkers and patient-reported outcomes related to urticaria control and quality of life will also be assessed.

For the HS group, 30 patients will be randomized into three dosing arms at 30 mg, 60 mg, and 90 mg BID. Efficacy measures will include changes in total abscess count, inflammatory nodules, and draining tunnels (dT), along with clinician-assessed global impression of change (CGI-C) and patient-reported outcomes related to disease control and quality of life.

Concurrent with these trials, InflaRx is conducting additional pre-clinical studies, including chronic toxicology assessments, to support longer-term dosing in future clinical trials.

Beyond CSU and HS, INF904 is seen as a potential "pipeline-in-a-product" with applications in various fields such as nephrology, neurology, and hematology. While the immediate focus is on immuno-dermatology, the company is open to exploring additional indications through potential future partnerships.

INF904 acts as an orally administered inhibitor of C5a-induced signaling via the receptor C5aR. It has demonstrated anti-inflammatory effects in multiple pre-clinical models and shows minimal inhibition of the cytochrome P450 3A4/5 enzymes, which are crucial for metabolizing various drugs and metabolites. A first-in-human study revealed that INF904 is well tolerated with no significant safety concerns. Pharmacokinetic and pharmacodynamic data indicate strong potential, achieving a significant blockade of C5a-induced neutrophil activation over a 14-day dosing period.

InflaRx, founded in 2007, uses its proprietary anti-C5a and anti-C5aR technologies to develop potent and specific inhibitors of the complement activation factor C5a and its receptor C5aR. The company has offices in Germany and the USA and focuses on discovering and commercializing treatments for inflammatory diseases.