InflaRx Begins Phase 2a Study Dosing for Oral C5aR Inhibitor INF904

In December 2024, the biopharmaceutical company InflaRx N.V. announced the initiation of a Phase 2a clinical trial for their promising drug, INF904. This trial, focused on chronic spontaneous urticaria (CSU) and hidradenitis suppurativa (HS), marks a significant step in the development of this oral C5a receptor inhibitor. Dr. Camilla Chong, the Chief Medical Officer at InflaRx, expressed confidence in the anti-inflammatory capabilities of INF904, emphasizing its potential to meet significant unmet needs in treating these conditions.

The trial, conducted across multiple centers, will involve 75 patients who suffer from moderate to severe forms of CSU and HS. The study aims to explore various dosing regimens of INF904 over a four-week treatment phase, followed by a four-week observation period. This will help generate additional safety data and assess pharmacokinetics, with results expected by the summer of 2025. The data will contribute to the design of an expansive Phase 2b study planned for later that year.

For the CSU segment of the trial, 45 participants will be divided into three groups. The first two groups will receive different dosages of INF904, specifically 60 mg and 120 mg twice daily. A third group consisting of patients who have not responded to anti-IgE treatments will receive a 120 mg twice-daily dose. The trial will evaluate the drug's efficacy using several measures, including changes in urticaria activity, hives severity, and itch severity scores from the beginning to the end of the treatment period. The study will also analyze biomarkers and patient-reported outcomes focusing on urticaria management and life quality improvement.

Meanwhile, in the HS cohort, 30 patients will be randomly assigned to receive one of three dosages: 60 mg, 90 mg, or 120 mg twice daily. The efficacy of the treatment for HS will be assessed using different metrics, such as changes in the count of abscesses, inflammatory nodules, and draining tunnels, alongside clinician evaluations of the condition's improvement. Like the CSU group, this part of the study will also consider patient-reported outcomes related to disease control, pain, and life quality.

InflaRx estimates that both CSU and HS have the potential to represent markets worth over $1 billion for INF904. The company is also investigating other possible applications for the drug across various immuno-inflammatory conditions, such as those in the fields of nephrology, neurology, and hematology. While InflaRx is currently concentrating its efforts on CSU and HS, it is open to future collaborations to explore additional therapeutic areas.

INF904, an orally administered small molecule, is designed to inhibit the C5a receptor. It has demonstrated anti-inflammatory effects in pre-clinical trials and shows minimal interaction with the cytochrome P450 3A4/5 enzymes, which are crucial for metabolizing many drugs, including steroids. Initial human trials have shown that INF904 is well tolerated without significant safety concerns across a range of doses. Pharmacokinetic and pharmacodynamic data from early studies indicate its strong potential in inhibiting C5a-induced neutrophil activation, a key factor in inflammation.

InflaRx, established in 2007, is a leader in developing anti-inflammatory therapeutics, utilizing its proprietary technologies to create potent and specific inhibitors targeting complement system components. The company operates from its headquarters in Jena, Germany, with additional offices in Munich and Ann Arbor, Michigan. Its flagship product, vilobelimab, is another testament to its innovative approach, having shown promising results in clinical trials for various inflammatory diseases.