InflaRx Reports New Mechanistic Data for Izicopan Supporting its Potential as a Best-in-Class C5aR Inhibitor

JENA, Germany, April 09, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced new in vitro findings demonstrating that izicopan does not exhibit time-dependent inhibition of CYP3A4, an important indicator for the risk for drug-drug interactions (DDIs) and liver toxicity. These results further support izicopan’s potential as a differentiated, best-in-class oral C5a receptor (C5aR) inhibitor.

To build upon previous CYP interaction data for izicopan, which showed only marginal inhibition of CYP3A4 (IC₅₀ = 62 µM) in a time-dependent inhibition (TDI) IC₅₀ shift assay, InflaRx conducted a mechanistically informative Ki-based TDI (Ki/Kinact) study. While TDI shift assays serve as rapid screening tools to identify potential time-dependent inhibition, Ki/Kinact studies provide a more definitive and quantitative assessment, enabling a reliable determination of the presence or absence of time-dependent inhibition.

The Ki-based TDI study confirms that izicopan does not inhibit CYP3A4 (IC₅₀ > 100 µM) and exhibits no time-dependent inhibition up to the highest tested concentration (100 µM), supporting a low risk of clinically relevant DDIs. Using two probe substrates, midazolam (MDZ) and testosterone (TES), no evidence of CYP3A4 time-dependent inhibition was observed, providing mechanistic confirmation of izicopan’s favorable pharmacological profile. This feature is particularly important, as time-dependent CYP3A4 inhibition can result in DDIs, hepatotoxicity, or reduced metabolism of concomitant medications such as corticosteroids.

Prof. Renfeng Guo, Chief Scientific Officer and Founder of InflaRx, commented: “These new mechanistic data highlight izicopan’s differentiated pharmacological profile, demonstrating no CYP3A4 time-dependent inhibition even at high concentrations. Combined with its favorable metabolic stability and human PK/PD profile, izicopan has the potential to minimize drug–drug interaction and liver toxicity risks, offering significant benefits for patients across multiple inflammatory diseases.”

About izicopan
Izicopan is an orally administered, small molecule inhibitor of the C5a receptor C5aR1 that has shown anti-inflammatory therapeutic effects in several pre-clinical disease models and in human studies. Further, in contrast to the marketed C5aR inhibitor, in vitro experiments demonstrated that izicopan does not inhibit the cytochrome P450 3A4 (CYP3A4) enzyme, which plays 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 izicopan was well tolerated in treated subjects and exhibited 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 to 90 mg twice per day for 14 days. Pharmacokinetic / pharmacodynamic data support the best-in-class potential of izicopan, with a ≥90% blockade of C5a-induced neutrophil activation achieved over the 14-day dosing period. Topline Phase 2a data further support the safety profile of izicopan, with no reported safety signals of concern. In patients with hidradenitis suppurativa, over 4 weeks of therapy, izicopan provided rapid and clinically meaningful reductions in abscesses and nodules (ANs) and draining tunnels (dTs), robust HiSCR responses that continued to deepen four weeks after the treatment period, and substantial reductions in patient-reported pain scores, overall demonstrating the potential for biologic-like efficacy. In chronic spontaneous urticaria, InflaRx observed substantial reductions in the 7-day Urticaria Activity Score (UAS7) broadly across patients and particularly in those with severe disease, as well as improved disease control as measured by the Urticaria Control Test (UCT7).

About InflaRx N.V.
InflaRx (Nasdaq: IFRX) is a biopharmaceutical company pioneering anti-inflammatory therapeutics by applying its proprietary anti-C5a and anti-C5aR technologies to discover, develop and commercialize highly potent and specific inhibitors of the complement activation factor C5a and its receptor, C5aR. C5a is a powerful inflammatory mediator involved in the progression of a wide variety of inflammatory diseases. InflaRx‘s lead program is izicopan, an orally administered small molecule inhibitor of C5a-induced signaling via the C5a receptor, which has shown promising PK/PD characteristics as well as therapeutic potential in Phase 1 and Phase 2a clinical studies. The Company is developing izicopan for the treatment of several inflammatory diseases, including hidradenitis suppurativa. InflaRx also has developed vilobelimab, a novel, intravenously delivered, first-in-class, anti-C5a monoclonal antibody that selectively binds to free C5a and has demonstrated disease-modifying clinical activity and tolerability in multiple clinical studies.

InflaRx was founded in 2007, and the group has offices and subsidiaries in Jena and Munich, Germany, as well as Ann Arbor, MI, USA. For further information, please visit www.inflarx.de. InflaRx GmbH (Germany) and InflaRx Pharmaceuticals Inc. (USA) are wholly owned subsidiaries of InflaRx N.V. (together, InflaRx).

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FORWARD-LOOKING STATEMENTS
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