ASC50 / Ascletis - LARVOL DELTA

Ascletis Announces Positive Results from 28-Day Proof-of-Concept Clinical Study in U.S. for ASC50, a First-in-Class and Best-in-Class Oral Small Molecule IL-17A Inhibitor for the Treatment of Plaque Psoriasis (PRNewswire) - "48.9% placebo-adjusted reduction in psoriasis area and severity index (PASI) score achieved in mild-to-moderate plaque psoriasis patients with once-daily 200 mg 28-day treatment. Steady-state elimination half-life after 28-day treatment in patients was 6.5 days, supporting potential once-weekly oral dosing. Placebo-adjusted reduction in PASI score reached 65.9% in mild-to-moderate plaque psoriasis patients 15 days after last dose (28th dose), which supports potential once-weekly oral dosing. Strong target engagement after 28-day dosing, indicated by elevated plasma interleukin-17A (IL-17A) levels."

P1 data • Plaque Psoriasis

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