InflaRx Announces Positive Topline Results from the Multiple Ascending Dose (MAD) Phase I Study with C5aR Inhibitor INF904

• MAD pharmacokinetic and pharmacodynamic data support best-in-class potential of INF904 over tested dose range of 30 mg once per day (QD) to 90 mg twice per day (BID) for 14 days:
  • Achieved ≥90% blockade of C5a-induced neutrophil activation over 14-day dosing period
  • Achieved favorable concentration-time profiles with target exposures of therapeutic potential
  • Well tolerated with no safety signals of concern over entire dose range
    
• Company to advance INF904 into Phase II clinical development
• Company to host a conference call today, January 4, 2024 at 8:30 a.m. EST/14:30 CET

JENA, Germany, Jan. 04, 2024 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today topline results from the multiple ascending dose (MAD) part of its randomized, double-blind, placebo-controlled Phase I trial for INF904, an orally administered low molecular weight C5aR inhibitor. The pharmacokinetic (PK) and pharmacodynamic (PD) parameters confirm the favorable data InflaRx reported recently from the single ascending dose (SAD) part of the study, which provides support for the best-in-class potential of this drug candidate. INF904 was well tolerated and there were no adverse safety events of concern after repeated dosing in participants over the entire tested dose range.

In the MAD part of the randomized, double-blind, placebo-controlled Phase I trial, 24 participants received multiple doses of INF904 for 14 days of either 30 mg once per day (QD), 30 mg twice per day (BID) or 90 mg BID. The study’s primary objective was to evaluate the safety and tolerability of repeated dosing. Several PK parameters were analyzed as secondary endpoints, and the effect of the dosing scheme on C5a-induced neutrophil activation in blood samples from the participants was also explored in an ex vivo assay.

“We are very pleased that the MAD part of the Phase I study exceeded the already compelling results from the SAD part of the study. The PK and PD profiles suggest that INF904 allows for highly effective inhibition of the C5a/C5aR pathway and that INF904 should enable consistent control of C5aR signaling in patients. In addition, we have the potential to apply a broad dose range up to high doses for the planned development of INF904 in chronic immune-inflammatory conditions,” said Camilla Chong, MD, Chief Medical Officer of InflaRx. “We are excited to advance this highly promising oral C5aR inhibitor into Phase II clinical development.”