• Thought leaders in complement inhibition, chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS) provide compelling new insights into the strong development rationales, potential differentiation and medical role of INF904 in initially targeted indications and inflammation & immunology (I&I) more broadly

• Additional details provided on INF904 Phase 2a trial design in moderate-to-severe CSU and HS, with study initiation expected by the calendar year-end of 2024 and a goal of generating additional safety and pharmacokinetic (PK) data, and showing meaningful clinical benefit

• INF904 Phase 2a data expected in summer 2025, with Phase 2b trial initiation expected in 2025

• Commercial assessment indicates CSU and HS both represent multi-billion-dollar market opportunities, with tremendous patient need for effective new mechanisms of action

• InflaRx's strong financial position is expected to fund company operations into 2026, allowing for advancement of clinical programs towards next milestones

JENA, Germany, June  05, 2024  (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today hosted a virtual R&D event focused on the company's oral small molecule C5aR inhibitor, INF904. Speakers provided additional details on development rationales and plans for INF904, as well as additional insight into its potential role in CSU and HS and its broader therapeutic potential in the immuno-inflammation field.

Presenting key opinion leaders (KOLs) included: Prof. Dr. Marcus Maurer (Professor of Dermatology and Allergology, Institute of Allergology, Charité – Universitätsmedizin Berlin, Germany), Christopher Sayed, MD (Prof. of Dermatology, University of North Carolina, Medical School; and Secretary of the HS Foundation) and Prof. Dr. Jörg Köhl (Director of the Institute for Systemic Inflammation Research, University of Lübeck, Lübeck, Germany).

Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, commented: "InflaRx has been eager to provide additional details of its development plans for INF904 and to further showcase the tremendous promise of our approach to C5aR inhibition, initially in CSU and HS, and more broadly in I&I. We see the immense potential of INF904 in its ability to address multiple significant unmet medical needs not addressed by drugs currently in development, as well as the ability for this potentially best-in-class compound to find market acceptance in a number of sizable patient settings. We expect to progress expeditiously in our two initially selected immuno-derm indications, CSU and HS, and look forward to achieving additional milestones with INF904 in 2025."

INF904 CSU and HS clinical development program
As previously disclosed, InflaRx will pursue two initial immuno-dermatology indications with INF904 in a single Phase 2a basket trial that is expected to begin by the end of 2024. The Phase 2a trial will be a multi-center, open-label study dosing 75 patients and evaluating multiple INF904 dosing regimens over 4 weeks of treatment in patients with moderate-to-severe CSU and moderate-to-severe HS.

Outcome measures will be assessed via weekly visits to evaluate safety, PK and preliminary signs of efficacy. After the 4-week treatment period, patients will be followed for an additional 4 weeks. Data from this study are expected in the summer of 2025, with the subsequent initiation of a larger Phase 2b study anticipated in 2025 as well.

In the CSU group, patients in Study Arms 1 and 2 will be dosed with INF904 at 30 mg and 90 mg BID (twice daily), respectively. Patients in Study Arm 3 will be comprised of anti-IgE non-responders and dosed at 90 mg BID. In total, the CSU group will dose 45 patients randomized at a 1:1:1 ratio. In addition to safety and PK parameters, assessed CSU efficacy measures will include change of 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 Outcome (PRO) endpoints related to urticaria control and quality of life will also be assessed.

In the HS group, 30 patients will be randomized at a 1:1:1 ratio to 3 doses of INF904 at 30 mg, 60 mg or 90 mg BID. In addition to safety and PK parameters, assessed HS efficacy measures will include change in total abscess, inflammatory nodule and draining tunnel (dT) count, HS lesions-related scores and Clinician's Global Impression of Change (CGI-C) at 4 weeks. PRO endpoints related to HS disease control and quality of life will also be assessed.

As previously disclosed, the company is currently conducting additional pre-clinical studies with INF904, including chronic toxicology studies, as part of its effort to enable longer-term dosing of INF904 in future clinical trials.

INF904 as a "pipeline-in-a-product"
Given the potential of INF904 to have a broad commercial footprint, InflaRx believes INF904 could address meaningful markets in immuno-dermatology and in immuno-inflammation, including in nephrology, neurology and hematology. While InflaRx intends to focus its resources on its immediate goals addressing CSU and HS, we continue to assess and monitor the value of pursuing additional areas and applications via potential future collaborations with partners.

About INF904
INF904 is an orally administered small molecule inhibitor of C5a-induced signaling via the receptor C5aR. INF904 showed anti-inflammatory therapeutic effects in several pre-clinical disease models. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that INF904 has minimal inhibition of the cytochrome P450 3A4/5 (CYP3A4/5) enzymes, which play an important role in the metabolism of a variety of metabolites and drugs, including glucocorticoids. Reported results from a first-in-human study demonstrated that INF904 is well tolerated in treated subjects and exhibits no safety signals of concern in single doses ranging from 3 mg to 240 mg or multiple doses ranging from 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days. Pharmacokinetic / pharmacodynamic data support best-in-class potential of INF904 with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period.