Sagimet Announces Positive 52-Week Data from License Partner Ascletis’ Open-Label Phase 3 Clinical Trial Evaluating the Long-Term Safety of ASC40 (Denifanstat) Tablets in Patients with Moderate to Severe Acne

Core Insights - Sagimet Biosciences Inc. is collaborating with Ascletis Pharma Inc. on the development of denifanstat (ASC40), a fatty acid synthase (FASN) inhibitor for treating moderate to severe acne, with positive topline results reported from a Phase 3 trial [1][2] Clinical Results - The Phase 3 open-label trial (ASC40-304) involved 240 subjects who received denifanstat 50 mg once daily for up to 40 weeks, following a 12-week double-blind trial [4] - Primary endpoints focused on safety, while secondary endpoints assessed efficacy, showing improvements in all efficacy measures beyond the 12-week mark [5] - Notable efficacy endpoints included a decrease in Investigator's Global Assessment (IGA) scores and reductions in total and inflammatory skin lesion counts [5][6] Safety Profile - Denifanstat was generally well tolerated, with treatment-emergent adverse events (TEAEs) occurring in 5.5% of subjects for dry eye syndrome and 5.2% for dry skin [7] - All adverse events related to denifanstat were mild or moderate, with no serious adverse events linked to the treatment [7] Market Context - Acne affects over 50 million people in the U.S., with a significant number requiring chronic management due to the lack of a definitive cure [9] - The inhibition of FASN is seen as a promising approach to address acne, as it plays a critical role in sebum production and inflammatory pathways [10]