Zhitong Finance App News, Goli Pharmaceutical-B (01672) announced that ASC50 achieved positive results in a randomized, double-blind, placebo-controlled 28-day proof-of-concept clinical trial conducted by ASC50 in patients with mild to moderate plaque psoriasis in the US. This phase I study aimed to evaluate the safety, efficacy, and pharmacokinetics (NCT07024602) of 200 mg ASC50 once daily after 28 days of treatment in patients with mild to moderate plaque psoriasis.
Key findings
In patients with mild to moderate plaque psoriasis who received 200 mg once a day for 28 days, the placebo-adjusted psoriatic area and severity index (PASI) score decreased by 48.9%.
The steady state elimination half-life (steady-state half-life) of 6.5 days in patients receiving 28 days of treatment is expected to support oral administration once a week.
On the 6th and 15th day after the last dose (28th dose), the placebo-corrected PASI score decreased to 60.7% and 65.9%, respectively. These data are expected to support weekly oral administration.
The decrease in the PASI score with a single daily dose of 200 mg was comparable to the published SecuKinumab data (not a head-to-head study). Secukinumab is a marketed interleukin-17a (IL-17A) antibody.
Significant targeted binding effects were shown after 28 days of administration, which showed an increase in plasma IL-17A levels.
Treatment of 200 mg once a day for 28 days is safe and well tolerated. All adverse events (AEs) were mild (grade 1) and of short duration. No serious adverse events (SAEs) were reported, and no participants withdrew during the study. Elevations in alanine aminotransferase (ALT) and aspartate aminotransferase (AST) were not observed. No liver safety signals were detected.
“The strong efficacy of this proof-of-concept clinical trial, along with encouraging safety and pharmacokinetic data, supports ASC50's promise to be the first-in-class (first-in-class) and best-in-class (best-in-class) oral small molecule IL-17A inhibitor, providing patients with an injection-free dosing option to replace injectable antibody therapy. “ASC50's novel skeleton showed a steady-state elimination half-life of 6.5 days in patients and is expected to support weekly oral administration.” Dr. Wu Jinzi, founder, chairman of the board of directors and CEO of Goli, said, “Compared with injectable antibody therapy, ASC50 can be expected to be an oral alternative treatment with differentiated advantages and benefit patients through weekly oral administration.”
ASC50 is an IL-17A targeted oral small molecule inhibitor independently developed by Goli. IL-17A has been fully biologically proven in various autoimmune and inflammatory diseases such as psoriasis, and has mature commercial value. ASC50 is a new chemical entity (NCE) with a novel skeleton.