InflaRx Reports Favorable Reactive Metabolite Profile for Izicopan in Human Liver Microsomes
Rhea-AI Summary
InflaRx (Nasdaq: IFRX) reported preclinical in vitro data showing low reactive metabolite formation for izicopan in human liver microsomes versus higher levels for avacopan. Differences exceeded 100-fold at 5–10 minutes and were ~10-fold at 20–40 minutes. InflaRx noted izicopan did not inhibit CYP3A4 in vitro and cited prior Phase 1 and Phase 2a safety and PK/PD data, including ≥90% blockade of C5a-induced neutrophil activation.
InflaRx cautioned that in vitro findings do not directly predict clinical outcomes but said the results support izicopan’s differentiated preclinical profile within the C5aR1 inhibitor class.
Positive
- Izicopan showed minimal reactive metabolite formation in human liver microsomes
- Reactive conjugate differences versus avacopan exceeded 100-fold at early time points
- Izicopan did not inhibit CYP3A4 in vitro
- Phase 1 data: well tolerated across single doses 3–240 mg and multiple doses up to 90 mg twice daily
- PK/PD: ≥90% blockade of C5a-induced neutrophil activation over 14 days
- Phase 2a topline data showed clinical activity in hidradenitis suppurativa and chronic spontaneous urticaria
Negative
- Results are from in vitro microsome assays and do not directly predict clinical safety or efficacy
- Comparative bioactivation data are preclinical and require clinical corroboration
- No new clinical efficacy or regulatory milestones were reported in this announcement
News Market Reaction – IFRX
In the May 4 session, IFRX gained 1.43%, reflecting a mild positive market reaction. Argus tracked a trough of -3.0% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Apr 28 | Listing compliance | Positive | +3.7% | Nasdaq confirms IFRX regained compliance with minimum bid price requirement. |
| Apr 09 | Mechanistic data | Positive | +8.4% | Izicopan shown not to exhibit time‑dependent CYP3A4 inhibition up to 100 µM. |
| Mar 31 | Conference participation | Positive | +7.5% | Company presents pipeline, including izicopan and vilobelimab, at Raymond James symposium. |
| Mar 30 | Clinical data update | Negative | -8.8% | Phase 3 vilobelimab PG trial stopped early for futility despite some efficacy signals. |
| Mar 19 | Earnings and pipeline | Positive | +3.4% | Full‑year 2025 results and positive Phase 2a izicopan data with funding to mid‑2027. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent IFRX news has generally seen share-price moves that align with the positive or negative tone of announcements, especially for izicopan mechanistic updates and major corporate milestones.
Over the last few months, InflaRx has highlighted several milestones around izicopan and corporate positioning. A March 19 earnings update emphasized positive Phase 2a data and a cash runway to mid‑2027. Subsequent news included new izicopan mechanistic data on April 9, participation in a Raymond James biotech symposium, and regaining Nasdaq minimum bid compliance on April 28. A vilobelimab Phase 3 futility stop in pyoderma gangrenosum on March 30 weighed on shares. Today’s pre‑clinical izicopan data fits the ongoing focus on its profile.
Key Terms
reactive metabolite medical
glutathione (GSH) trapping assay medical
cytochrome P450 3A4 (CYP3A4) medical
hidradenitis suppurativa medical
chronic spontaneous urticaria medical
urticaria activity score (UAS7) medical
urticaria control test (UCT7) medical
monoclonal antibody medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
JENA, Germany, May 04, 2026 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biopharmaceutical company pioneering anti-inflammatory therapeutics by targeting the complement system, today announced new pre-clinical data demonstrating low reactive metabolite formation of izicopan in human liver microsomes. Reactive metabolite formation is widely used in drug development as an early mechanistic indicator of potential bioactivation-related safety risk.
Izicopan is an investigational next-generation oral C5aR1 inhibitor designed to achieve differentiated pharmacological properties, with the potential for improved efficacy and safety. The marketed comparator, avacopan, is a first-in-class oral C5a receptor 1 (C5aR1) inhibitor approved for the treatment of ANCA-associated vasculitis.
In a head-to-head in vitro study using a standard glutathione (GSH) trapping assay in human liver microsomes (10 µM; 0–40 minute incubation), izicopan demonstrated minimal reactive metabolite formation, with conjugate remaining low throughout the incubation period. These findings support a low level of bioactivation in this assay system.
Under the same experimental conditions, avacopan showed higher levels of thiol adducts, including both glutathione and downstream cysteine conjugates, consistent with more extensive oxidative bioactivation. Differences in total reactive conjugate peak areas were most pronounced at early time points (exceeding 100-fold at 5 and 10 minutes) and remained observable over the course of the assay (approximately 10-fold at 20 and 40 minutes). Overall, these results suggest a lower extent of reactive intermediate formation for izicopan in this experimental setting. While in vitro findings do not directly predict clinical outcomes, InflaRx believes these results support the differentiated profile of izicopan.
Prof. Renfeng Guo, Chief Scientific Officer and Founder of InflaRx, commented: “These data provide additional insight into the mechanistic profile of izicopan. We believe that, if supported by clinical data, such properties may contribute to its overall differentiation within the C5aR inhibitor class.”
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 ≥
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).
Contacts:
| InflaRx N.V. | MC Services AG |
| Jan Medina, CFA Vice President, Head of Investor Relations Email: IR@inflarx.de | Katja Arnold, Laurie Doyle, Dr. Regina Lutz Email: inflarx@mc-services.eu Europe: +49 89-210 2280 U.S.: +1-339-832-0752 |
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements. All statements other than statements of historical fact are forward-looking statements, which are often indicated by terms such as “may,” “will,” “should,” “expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “estimate,” “believe,” “predict,” “potential” or “continue,” among others. Forward-looking statements appear in a number of places throughout this release and may include statements regarding our intentions, beliefs, projections, outlook, analyses and current expectations concerning, among other things, the success of our future clinical trials for vilobelimab's treatment of other debilitating or life-threatening inflammatory indications, including acute respiratory distress syndrome, or ARDS; potential strategic transactions or collaborations, including a potential partnership of izicopan, or vilobelimab for PG; the success of our future clinical trials for izicopan, and whether such clinical results will reflect results seen in previously conducted pre-clinical studies and clinical trials; the timing, progress and results of pre-clinical studies and clinical trials of vilobelimab, izicopan and any other of our product candidates and statements regarding the timing of initiation and completion of studies or trials and related preparatory work, the period during which the results of the trials will become available, the costs of such trials and our research and development programs generally; our interactions with regulators regarding the results of clinical trials and potential regulatory approval pathways, including related to our biologics license application submission for GOHIBIC (vilobelimab), and our ability to obtain and maintain full regulatory approval of vilobelimab or GOHIBIC (vilobelimab) for any indication; whether the FDA, or any comparable foreign regulatory authority will accept or agree with the number, design, size, conduct or implementation of our clinical trials, including any proposed primary or secondary endpoints for such trials; our ability to leverage our proprietary anti-C5a and anti-C5aR technologies to discover and develop therapies to treat complement-mediated immunological and inflammatory diseases; our ability to protect, maintain and enforce our intellectual property protection for vilobelimab, izicopan and any other product candidates, and the scope of such protection; our manufacturing capabilities and strategy, including the scalability and cost of our manufacturing methods and processes and the optimization of our manufacturing methods and processes, and our ability to continue to rely on our existing third-party manufacturers and our ability to engage additional third-party manufacturers for our planned future clinical trials and for commercial supply of vilobelimab and for the finished product GOHIBIC (vilobelimab); our estimates of our expenses, ongoing losses, future revenue, capital requirements and our needs for or ability to obtain additional financing; our ability to defend against liability claims resulting from the testing of our product candidates in the clinic or, if approved, any commercial sales; if any of our product candidates obtain regulatory approval, our ability to comply with and satisfy ongoing obligations and continued regulatory overview; our ability to comply with enacted and future legislation in seeking marketing approval or commercialization; our future growth and ability to compete, which depends on our retaining key personnel and recruiting additional qualified personnel; and our competitive position and the development of and projections relating to our competitors in the development of C5a and C5aR inhibitors or our industry; and the risks, uncertainties and other factors described under the heading “Risk Factors” in our periodic filings with the SEC. These statements speak only as of the date of this press release and involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Given these risks, uncertainties and other factors, you should not place undue reliance on these forward-looking statements, and we assume no obligation to update these forward-looking statements, even if new information becomes available in the future, except as required by law.
