Ascletis Announces Positive Topline Results from U.S. Phase I Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor

Core Insights - Ascletis Pharma Inc. announced positive topline results from a Phase I clinical trial for ASC50, an oral small molecule inhibitor targeting IL-17, indicating favorable safety, tolerability, and pharmacokinetics [3][5][7] Group 1: Clinical Trial Results - The Phase I clinical trial was randomized, double-blind, and placebo-controlled, involving 46 healthy participants who received varying doses of ASC50 [3] - ASC50 demonstrated a dose-proportional pharmacokinetic profile from 10 mg to 600 mg, with an elimination half-life ranging from 43 to 104 hours depending on the dose [1][2][8] - All adverse events reported were mild and transient, with no serious adverse events or discontinuations noted during the study [8] Group 2: Target Engagement and Efficacy - Strong target engagement was observed with elevated plasma IL-17A levels persisting until day 7 for higher doses of ASC50 [1][8] - The drug showed higher absolute oral bioavailability and longer half-life compared to another IL-17 inhibitor currently in clinical development [8] Group 3: Future Development - Based on the positive results, ASC50 is advancing to the next phase of clinical development, focusing on multiple ascending doses in participants with mild to moderate plaque psoriasis [5] - ASC50 is positioned as a potential best-in-class oral small molecule IL-17 inhibitor, developed using Artificial Intelligence-assisted Structure-Based Drug Discovery technology [6][7]