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Ascletis Reports Positive Phase I Results for Oral Psoriasis Drug ASC50

Ascletis Reports Positive Phase I Results for Oral Psoriasis Drug ASC50

A 28-day clinical trial in the U.S. has yielded encouraging results for ASC50, an oral small molecule inhibitor targeting IL-17A. Patients with mild-to-moderate plaque psoriasis receiving a 200 mg daily dose showed significant symptom reduction and a favorable safety profile, paving the way for potential once-weekly administration.

The proof-of-concept study (NCT07024602) demonstrated a 48.9% placebo-adjusted reduction in the Psoriasis Area and Severity Index (PASI) score after four weeks of treatment. Notably, the drug’s efficacy continued to improve after the final dose, with the placebo-adjusted reduction climbing to 65.9% by day 15 post-treatment. This sustained effect, combined with a steady-state elimination half-life of 6.5 days, suggests the drug could be effective with a once-weekly oral dosing regimen.

Safety data provided further support for the candidate. Participants experienced only mild, transient adverse events, with no reports of serious complications or hepatic safety signals such as elevations in liver enzymes. Jinzi Jason Wu, CEO of Ascletis, noted that the candidate’s novel scaffold offers a potential needle-free alternative to current injectable antibody therapies, such as secukinumab, while maintaining comparable efficacy. As an in-house developed new chemical entity, ASC50 represents a significant milestone in the company’s efforts to address autoimmune and inflammatory conditions through specialized oral therapeutics.

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