ASC50 / Ascletis - LARVOL DELTA

Ascletis Announces First Participants Dosed in U.S. Phase I Clinical Study of ASC50, a Potential Best-in-Class Oral Small Molecule IL-17 Inhibitor for the Treatment of Psoriasis (PRNewswire) - "Ascletis Pharma...announces that the first healthy participants have been dosed in a randomized, double-blind, placebo-controlled Phase I clinical trial in the U.S., evaluating the safety, tolerability and preliminary efficacy of ASC50 (NCT07024602) for the treatment of psoriasis. ASC50 is an in-house discovered and developed oral small molecule inhibitor targeting interleukin-17 (IL-17), an important biologically and commercially validated target for multiple autoimmune and inflammatory diseases, including psoriasis. The Phase I clinical trial of ASC50 oral tablets, conducted at multiple sites in the U.S., is a randomized, double-blind, placebo-controlled, first-in-human study of both healthy participants and patients with mild-to-moderate plaque psoriasis."

Trial status • Psoriasis

Ascletis Announces U.S. FDA Clearance of IND Application for Its Oral Small Molecule IL-17 Inhibitor, ASC50, for the Treatment of Psoriasis (PRNewswire) - "Ascletis Pharma Inc...announces the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for a Phase I trial for ASC50 for the treatment of mild-to-moderate plaque psoriasis....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."

IND • New P1 trial • Immunology • Psoriasis