Globenewswire·2026-02-02 12:00Core Viewpoint - Sagimet Biosciences Inc. is advancing the development of denifanstat (ASC40), a fatty acid synthase (FASN) inhibitor, which has shown positive results in clinical trials for treating moderate to severe acne, indicating its potential as a novel therapeutic option in this area [1][2][3]. Clinical Results - The Phase 3 open-label trial (ASC40-304) enrolled 240 subjects who received denifanstat 50 mg once daily for up to 40 weeks, following a previous 12-week double-blind trial [4]. - Denifanstat demonstrated improvements in all efficacy endpoints beyond the 12-week results, including significant reductions in skin lesion counts and improvements in Investigator's Global Assessment (IGA) scores [5][6]. Safety Profile - Denifanstat was generally well tolerated, with only mild to moderate treatment-emergent adverse events (TEAEs) reported, including dry eye syndrome (5.5%) and dry skin (5.2%) [7]. - No serious adverse events (SAEs) related to denifanstat were reported, and all adverse events were manageable, with no permanent discontinuations due to treatment [7]. Market Context - Acne affects over 50 million people in the U.S., with a significant number requiring chronic management, highlighting the need for effective treatment options [9]. - The inhibition of FASN is considered a promising approach due to its role in sebum production and inflammatory pathways associated with acne [9].