Ascletis Pharma said the FDA has cleared the investigational new drug application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17. The Phase I clinical trial of ASC50 is a randomized, double-blind, placebo-controlled study and will be conducted at multiple sites in the U.S. Dosing of patients with mild-to-moderate plaque psoriasis is expected to start in the third quarter of 2025.
Jinzi Jason Wu, CEO of Ascletis, said: "The IND clearance of ASC50 marks a new milestone for Ascletis in autoimmune and inflammatory diseases."
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