Ascletis reports positive phase 1 results for oral IL-17 inhibitor ASC50

Ascletis Pharma Inc. reported positive topline data from a randomized, double-blind, placebo-controlled Phase 1 clinical trial for ASC50 in healthy participants. The study, involving 46 individuals, evaluated the safety, tolerability, pharmacokinetics, and target engagement of ASC50 at doses ranging from 10 mg to 600 mg. Key findings include dose-proportional pharmacokinetics, strong target engagement shown by elevated plasma IL-17A levels, and an elimination half-life supporting once-daily or potentially once-weekly oral dosing (43-104 hours across various doses).

The trial indicated ASC50 was safe and well-tolerated across all dose levels, with all adverse events being mild and transient. No serious adverse events or discontinuations were reported. This favorable safety profile, combined with strong target engagement and pharmacokinetic results, has enabled ASC50 to advance to the next phase of clinical development, specifically a multiple ascending dose study in participants with mild to moderate plaque psoriasis.

ASC50, an in-house developed new chemical entity, holds U.S. and global patent protection through 2043. The company will host a conference call on December 15, 2025, at 8:00 p.m. China Standard Time to discuss these results.