1. WHO granted the INN 'izicopan' for InflaRx's INF904, enhancing brand recognition. 2. Izicopan shows potential in treating hidradenitis suppurativa and chronic spontaneous urticaria. 3. No safety concerns detected from izicopan in clinical trials, supporting its commercial viability. 4. Izicopan may target significant unmet needs in inflammatory disease treatments. 5. InflaRx aims to address sizable markets with its innovative C5aR inhibitor.
FAQ
Why Bullish?
The WHO naming enhances izicopan's visibility and credibility, akin to past positive FDA approvals boosting stocks. Similar instances include the FDA's naming of drugs like 'Kymriah', which positively impacted their market performance.
How important is it?
The announcement directly relates to izicopan's potential success and commercial prospects, critical for IFRX's growth narrative.
Why Short Term?
The immediate awareness from the INN may catalyze investor sentiment, similar to when Gilead’s hepatitis C drug was announced. Market reactions often occur rapidly following such announcements.
InflaRx Receives International Nonproprietary Name for Izicopan
JENA, Germany, Dec. 11, 2025 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a leading biopharmaceutical company specializing in anti-inflammatory therapeutics, has announced that the World Health Organization (WHO) has officially assigned the international nonproprietary (generic) name "izicopan" to its orally available C5a receptor (C5aR) inhibitor, previously known as INF904. This action follows the WHO's established guidelines for the selection of recommended INNs for pharmaceutical substances.
Significance of the INN Granting for Izicopan
The approval of the name "izicopan" marks a significant step forward for InflaRx in its efforts to bring this promising treatment option to market. Prof. Niels C. Riedemann, Chief Executive Officer and Founder of InflaRx, noted, “InflaRx welcomes the granting of izicopan as the INN for INF904. We believe the promising clinical data recently reported in hidradenitis suppurativa and chronic spontaneous urticaria indicate the tremendous potential izicopan has to address significant unmet needs in both diseases.”
Clinical Overview of Izicopan (INF904)
Izicopan (INF904) is an orally administered, small molecule inhibitor of the C5a receptor that has demonstrated significant anti-inflammatory therapeutic effects across various pre-clinical disease models and human studies. Key findings about izicopan include:
- Minimal CYP3A4/5 Inhibition: Unlike other marketed C5aR inhibitors, izicopan exhibits minimal inhibition of cytochrome P450 enzymes, crucial for metabolizing numerous drugs, including glucocorticoids.
- Safety Profile: A first-in-human study indicated that izicopan was well tolerated, with no significant safety concerns at doses ranging from 3 mg to 240 mg.
- Efficient Blockade: Izicopan achieved a ≥90% blockade of C5a-induced neutrophil activation throughout a 14-day dosing period.
Impact on Chronic Conditions
In clinical trials for patients suffering from hidradenitis suppurativa, izicopan demonstrated rapid and clinically meaningful reductions in abscesses and nodules. Notably, robust High-Intensity Short-Response (HiSCR) responses continued to improve four weeks post-treatment, along with significant reductions in self-reported pain scores. In patients with chronic spontaneous urticaria, substantial improvements were observed in the 7-day Urticaria Activity Score (UAS7), especially among those with severe disease, emphasizing izicopan's potential for effective disease management.
About InflaRx N.V.
Founded in 2007, InflaRx (Nasdaq: IFRX) is at the forefront of anti-inflammatory drug development, utilizing its proprietary anti-C5a and anti-C5aR technologies. The company aims to commercialize highly potent inhibitors that target the complement activation factor C5a, a critical inflammatory mediator in many autoimmune and inflammatory conditions. InflaRx is also advancing its other candidate, vilobelimab, an intravenously delivered anti-C5a monoclonal antibody.
Contact Information
For more inquiries, please reach out to InflaRx N.V. through the following contacts:
- Jan Medina, Vice President, Head of Investor Relations - Email: IR@inflarx.de
- MC Services AG - Email: inflarx@mc-services.eu
- Europe: +49 89-210 2280
- U.S.: +1-339-832-0752
Forward-Looking Statements
This announcement includes forward-looking statements that involve risks and uncertainties. These statements may relate to expectations about the commercial viability of izicopan, patient acceptance, clinical trial results, and regulatory approvals. Actual results may differ significantly from those projected.