Positive Phase 3 Results for Denifanstat for the Treatment of Moderate to Severe Acne to be Presented at the EADV Congress 2025 by Partner Ascletis

Core Insights - Sagimet Biosciences has reported that its lead drug candidate, denifanstat, has successfully met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris [2][3][4] Group 1: Clinical Trial Results - The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled study involving 480 patients in China, assessing denifanstat at a dosage of 50 mg once daily for 12 weeks [3] - Denifanstat achieved an 18.6% placebo-adjusted increase in treatment success rate, a 22.0% placebo-adjusted reduction in total lesions, and a 20.2% placebo-adjusted reduction in inflammatory lesions [4] - The drug was generally well tolerated among participants [3][4] Group 2: Company Developments - 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. [5][7] - Denifanstat is also being developed for metabolic dysfunction associated steatohepatitis (MASH) and has received Breakthrough Therapy designation from the FDA for this indication [6] Group 3: Market Context - Acne affects over 50 million people annually in the U.S., with a significant market opportunity due to the chronic nature of the condition and the need for ongoing management [5][8] - The U.S. acne market includes approximately 5.1 million patients treated by dermatologists each year, highlighting the demand for innovative treatment options [8]