Ascletis Announces U.S. FDA Clearance of IND Application for Its Oral Small Molecule IL-17 Inhibitor, ASC50, for the Treatment of Psoriasis

Core Insights - Ascletis Pharma Inc. has received FDA clearance for the investigational new drug (IND) application for ASC50, an oral small molecule IL-17 inhibitor aimed at treating mild-to-moderate plaque psoriasis [3][6] - ASC50 shows promising preclinical data, including higher oral exposure, longer half-life, and strong efficacy, positioning it as a potential best-in-class treatment for psoriasis [2][4] Company Overview - Ascletis is an innovative R&D driven biotech company listed on the Hong Kong Stock Exchange, focusing on metabolic and other diseases while addressing unmet medical needs globally [7] - The company utilizes an Artificial Intelligence-assisted Structure-Based Drug Discovery (AISBDD) platform for drug development, with ASC50 being the first oral small molecule candidate in immunology from this platform [6] Clinical Development - The Phase I clinical trial for ASC50 will be a randomized, double-blind, placebo-controlled study conducted at multiple sites in the U.S., with patient dosing expected to start in the third quarter of 2025 [5][6] - Preclinical studies indicate that ASC50 has a lower clearance rate compared to existing oral IL-17 inhibitors currently in clinical development, suggesting a potentially advantageous pharmacokinetic profile [4]