Ascletis' oral psoriasis drug, ASC50, cleared for U.S. trials

Ascletis Pharma Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for ASC50, an oral small molecule interleukin-17 (IL-17) inhibitor, for the treatment of mild-to-moderate plaque psoriasis. ASC50 was discovered and developed in-house and targets IL-17, a validated target for autoimmune and inflammatory diseases. Preclinical data showed that ASC50 has demonstrated higher drug exposure, a longer half-life, and greater efficacy compared to other IL-17 inhibitors currently in clinical development. Ascletis anticipates initiating a Phase I trial in patients with mild-to-moderate plaque psoriasis in the third quarter of 2025, and the trial will be a randomized, double-blind, placebo-controlled study conducted at multiple U.S. sites. The Board states that ultimately there is no guarantee that they will be able to successfully develop, manufacture and/or commercialize ASC50.