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InflaRx Announces Positive Topline Results from the Single Ascending Dose (SAD) Phase I Study with C5aR Inhibitor INF904
SAD data confirm best-in-class potential for INF904 as orally administered C5aR inhibitor: Safety and tolerability with no signals of concern over entire dose
About this update from Inflarx N.v.
[{"type":"text","content":"SAD data confirm best-in-class potential for INF904 as orally administered C5aR inhibitor: Safety and tolerability with no signals of concern over entire dose rangePharmacokinetics (PK): favorable dose-proportional systemic exposure with overall PK profile confirming pre-clinical dataDesired blocking activity (>90%) of C5a-induced neutrophil activation at disease relevant C5a levels 24 hours post administration for doses of 30 mg to 240 mgINF904 can be formulated with drug strength of 30 mg per capsule Data from the ongoing multiple ascending dose (MAD) part of the study to be presented in early 2024Company to host a conference call today, September 11, 2023 at 8:30 am EDT/14:30 CEST JENA, Germany, Sept. 11, 2023 (GLOBE NEWSWIRE) -- InflaRx N.V. (Nasdaq: IFRX), a biotechnology company pioneering anti-inflammatory therapeutics targeting the complement system, announced today 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. “Our team has spent several years developing an orally administered inhibitor of the terminal complement C5a / C5aR pathway with optimized PD and PK properties primarily for the long-term treatment of patients with chronic inflammatory conditions in need of improved therapeutic options. We are very pleased that the results announced today confirm our pre-clinical studies with INF904, which did not reveal any safety concerns and demonstrated favorable PK and PD profiles. We look forward to seeing th...