InflaRx has recently announced positive topline results from the single ascending dose (SAD) part of its Phase I trial for INF904, a C5aR inhibitor taken orally. The trial, which is randomized and double-blind, demonstrated that INF904 exhibited a favorable safety and tolerability profile, as well as a promising pharmacokinetic and pharmacodynamic profile.
The SAD portion of the Phase I trial involved the enrollment of 62 healthy volunteers across six different dosing groups, with doses ranging from 3 mg to 240 mg. Notably, different concentrations of the drug were tested within the 60 mg dosing group. The primary objectives of this part of the trial were to evaluate the safety and tolerability of single ascending doses under fasting conditions.
The results revealed that INF904 was well-tolerated by the patients, with no safety concerns observed at any dosage level. The incidence of adverse events was lower in the INF904 treated group compared to the placebo group, and no serious or severe adverse events were recorded. Additionally, there were no adverse events associated with INF904 dosing.
Furthermore, the administration of single doses of 30 mg or higher demonstrated a blocking efficacy of over 90% against C5a-induced up-regulation of the CD11b activation marker on neutrophils in plasma samples. This indicates that INF904 effectively controlled C5aR activation at disease-relevant C5a levels.
The Phase I trial is still ongoing, and InflaRx plans to present results from the 24 healthy volunteers in early 2024. To support future clinical development of INF904 in chronic inflammatory diseases, the company is preparing for additional pre-clinical studies, including chronic toxicology studies.