Core Insights - Sagimet Biosciences Inc. reported that denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for moderate to severe acne vulgaris conducted by Ascletis in China [3][9] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor, with plans for further development in the U.S. for acne treatment [3][9] - The Phase 3 trial demonstrated significant efficacy, with denifanstat showing a treatment success rate of 33.2% compared to 14.6% for placebo [8] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [10] - The lead drug candidate, denifanstat, is also being developed for metabolic dysfunction associated with steatohepatitis (MASH) and has received Breakthrough Therapy designation from the FDA [10] - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [3][10] Clinical Trial Details - The Phase 3 trial was a randomized, double-blind, placebo-controlled study involving 480 patients, with a treatment duration of 12 weeks [5][7] - Primary endpoints included treatment success defined by Investigator's Global Assessment (IGA) score, total lesion count, and inflammatory lesion count [7][8] - Denifanstat demonstrated a 57.4% reduction in total lesion count compared to a 35.4% reduction in the placebo group [8] Efficacy Results - Denifanstat achieved a significant percentage change in inflammatory lesion count of -63.5% versus -43.2% for placebo, with a p-value of <0.0001 [8] - The absolute change in total lesion count was -58.3 for denifanstat compared to -36.2 for placebo, indicating a strong therapeutic effect [8] - The treatment was generally well-tolerated, with no serious adverse events reported [8][9] Market Context - Acne affects over 640 million people globally, with more than 50 million in the U.S. alone, highlighting a significant market opportunity for effective treatments [4][11] - Current acne treatments often have limited efficacy or potential side effects, making the development of new therapeutic approaches critical [4][11]