Sagimet Biosciences(US:SGMT) Goldman Sachs·2025-06-05 05:45Investment Rating - The report designates Sagimet Biosciences (SGMT) as an Early-Stage Biotech with a focus on denifanstat for acne treatment [10]. Core Insights - Positive topline results from a Phase 3 trial of denifanstat in moderate to severe acne were announced, showing statistically significant improvements over placebo on all primary endpoints [1][2]. - The trial involved 480 patients and demonstrated a treatment success rate of 33.2% for denifanstat compared to 14.6% for placebo, with significant reductions in total and inflammatory lesion counts [7][8]. - The favorable safety profile of denifanstat was noted, with comparable rates of treatment-related adverse events (TRAEs) between denifanstat and placebo [5][6]. Summary by Sections Trial Results - The Phase 3 trial was randomized, double-blind, and placebo-controlled, evaluating denifanstat's efficacy and safety over a 12-week period [2]. - Key primary endpoints included the percentage of patients achieving treatment success, percentage reduction in total lesion count, and percentage reduction in inflammatory lesion count [3][5]. - Denifanstat achieved a 57.4% reduction in total lesion count and a 63.5% reduction in inflammatory lesion count compared to 35.4% and 43.2% for placebo, respectively [7]. Regulatory and Financial Implications - Ascletis plans to submit for regulatory approval in China imminently, which could lead to milestone payments of up to $122 million for SGMT [1][8]. - SGMT retains rights to denifanstat outside of China, allowing for potential development in the U.S. market, although regulatory pathways remain uncertain [8][9]. Future Development - The data from the trial supports SGMT's internal efforts with its next-generation FASN inhibitor, TVB-3567, which is currently in a Phase 1 trial for moderate to severe acne [9]. - The U.S. acne market is estimated to have a patient population of approximately 50 million, with SGMT expressing enthusiasm for the potential of TVB-3567 [9].