Positive Phase I MAD Results for C5aR Inhibitor INF904

InflaRx N.V., a biotech firm specializing in anti-inflammatory treatments, has unveiled positive interim findings from a Phase I clinical trial of their drug INF904. This medication is an orally administered C5aR inhibitor, designed to combat inflammation by targeting the complement system. The trial involved 24 participants who were given varying doses of INF904 over a 14-day period. The primary goal was to assess the drug's safety and tolerability, with secondary objectives examining pharmacokinetic parameters and the drug's impact on neutrophil activation.

The results indicate that INF904 was well-tolerated, with no concerning adverse events reported. The drug demonstrated a high percentage of adverse events lower than the placebo group, and no serious or severe adverse events were observed. Pharmacokinetic analysis revealed that INF904 achieved target values rapidly with dosing, and exposure increased proportionally with higher doses. The pharmacodynamic profile showed that INF904 blocked C5a-induced neutrophil activation by over 90% throughout the dosing period.

Dr. Camilla Chong, Chief Medical Officer of InflaRx, expressed enthusiasm for the drug's potential, noting its effectiveness in inhibiting the C5a/C5aR pathway and the possibility of a broad dosing range for chronic immune-inflammatory conditions. InflaRx plans to advance INF904 into Phase II clinical development and is also working on a commercially viable formulation of the drug for future trials.

The company has also been conducting additional pre-clinical studies, including chronic toxicology studies, to prepare for longer-term dosing of INF904 in chronic inflammatory diseases. They intend to initiate a short-term dosing Phase II study towards the end of 2024, followed by a longer-term dosing study in 2025. Further details regarding the clinical development plan and target indications will be announced in due course.

INF904 is an innovative oral C5aR inhibitor that has shown promising anti-inflammatory effects in pre-clinical models. Unlike other C5aR inhibitors, INF904 has minimal impact on cytochrome P450 450 3A4/5 enzymes, which are crucial for metabolizing various substances and medications. The drug's pharmacokinetic and pharmacodynamic data support its potential as a leading treatment, with a high blockade of C5a-induced neutrophil activation sustained over the 14-day dosing period.

InflaRx, founded in 2007, is dedicated to developing potent and specific inhibitors targeting C5a and its receptor C5aR, which play a significant role in inflammatory diseases. Their lead product, vilobelimab, is an anti-C5a monoclonal antibody that has shown clinical activity and tolerability in various indications. The company has a presence in Germany and the United States and is committed to advancing anti-inflammatory therapeutics.