India, Oct. 22 -- Sagimet Biosciences (SGMT) announced that the first patient has been dosed in AURORA, its pivotal U.S. Phase 3 clinical trial evaluating denifanstat for moderate to severe acne in adults and adolescents aged 12 years and older.
The trial is designed to support a potential U.S. New Drug Application (NDA) submission. Sagimet expects to enroll approximately 800 patients, including around 450 adolescents aged 12 to 17 years. Participants will receive denifanstat 50 mg once daily or placebo for 12 weeks, followed by a 40-week open-label extension for eligible patients.
Denifanstat is an oral, once-daily fatty acid synthase (FASN) inhibitor designed to target sebum production and inflammation, key contributors to acne. The can...