Sagimet Biosciences’ denifanstat has successfully met all primary and secondary endpoints in a Phase 3 clinical trial for treating moderate to severe acne, conducted by its partner Ascletis in China. The trial, which enrolled 480 patients, showed significant efficacy, with a treatment success rate of 33.2% for denifanstat compared to 14.6% for placebo. The results also indicated a 57.4% reduction in total lesion count, highlighting denifanstat’s potential as a novel therapeutic option for acne.
In addition, Sagimet has initiated a Phase 1 trial for another fatty acid synthase inhibitor, TVB-3567, to be developed in the U.S. for acne treatment. Denifanstat was reported to be well tolerated, with minimal serious adverse events. The trial outcomes underscore a promising new approach in a field that has seen limited innovation for decades, addressing the needs of over 640 million acne sufferers globally.
