Sagimet Biosciences (NASDAQ:SGMT) announced Monday that its China-based partner, Ascletis Pharma, reported positive topline results from a Phase 3 open-label safety study of denifanstat (ASC40) in patients with moderate to severe acne.
The 52-week data confirmed the oral, once-daily fatty acid synthase (FASN) inhibitor is well-tolerated and continues to show efficacy improvements well beyond the initial 12-week treatment period.
The study, which enrolled 240 subjects, met its primary safety endpoints with no drug-related serious adverse events (SAEs) or grade 3/4 side effects.
Only two adverse events occurred in more than 5% of patients: dry eye (5.5%) and dry skin (5.2%).
Notably, secondary efficacy results showed that patients experienced continued reductions in total and inflammatory lesion counts through the full year of treatment, strengthening the drug's position as a potential breakthrough in a market that has seen little innovation in decades.
Denifanstat operates through a novel dual mechanism: it directly inhibits de novo lipogenesis (fat synthesis) to reduce sebum production in the skin and downregulates inflammatory cytokines.
While Ascletis is currently advancing the drug toward approval in China—with a New Drug Application (NDA) already accepted—Sagimet is leveraging these results to bolster its global pipeline.
Sagimet is primarily developing denifanstat for metabolic dysfunction-associated steatohepatitis (MASH), where it recently received FDA Breakthrough Therapy designation, but it also plans to initiate a U.S. Phase 2 trial for acne using its second FASN candidate, TVB-3567, later this year.