InflaRx announces results from its SAD Phase I study with INF904

InflaRx N.V. announced its topline results from the single ascending dose, SAD, part of its randomized, double-blind, placebo-controlled Phase I trial of the orally administered, low molecular weight C5aR inhibitor INF904. In the SAD part of the study, INF904 demonstrated an excellent safety and tolerability profile as well as a very favorable pharmacokinetic, PK, and pharmacodynamic, PD, profile, confirming INF904’s best-in-class potential. The SAD part of the Phase I first-in-human trial enrolled 62 healthy volunteers within six different dosing groups from 3 mg to 240 mg who were randomly assigned to receive INF904 or a placebo. Different drug concentrations were tested for the 60 mg dosing group. The main objectives were to assess safety and tolerability of single ascending doses under fasting conditions. Secondary endpoints included several PK parameters, and the effect of INF904 on C5a-induced neutrophil activation in blood samples from treated volunteers ex vivo also was explored. The results show that INF904 was well tolerated in treated patients and resulted in no safety signals of concern in single doses ranging from 3 mg to 240 mg. The overall percentage of adverse events was lower in the INF904 treated patients compared to the placebo group, and no serious or severe AEs were observed at any dosing level. No related AEs were reported in conjunction with INF904 dosing. Analysis of INF904 PK in subject plasma samples revealed sustained exposure to INF904 with six hours to maximum concentration. INF904 plasma levels were dose proportional for systemic exposure and nearly dose proportional for maximum concentration over the dose range used in the study. With the 30 mg dose, INF904 reached a Cmax of 289 ng/ml with an AUClast of 5197 h.ng/ml, which are approximately 3-fold and 10-fold, respectively, higher than the published Phase I data from the only marketed comparator. Single doses of 30 mg or higher of INF904 achieved greater than or equal to90% blocking of C5a induced up-regulation of the activation marker CD11b on neutrophils in plasma samples from subjects ex vivo at 24 hours post dosing. The MAD part of the Phase 1 trial is ongoing, and the Company expects to present results from the approximately 24 healthy volunteers at the beginning of 2024.