The once-daily FASN inhibitor met all primary and secondary endpoints for treating moderate to severe acne, with data to be presented at the EADV Congress.
Data from a Phase 3 clinical trial for Sagimet Biosciences’ denifanstat, an investigational once-daily oral fatty acid synthase (FASN) inhibitor, showed the drug met all primary and secondary endpoints for the treatment of moderate to severe acne vulgaris. The results will be presented at the European Academy of Dermatology and Venerology (EADV) 2025 Congress.
The multicenter, randomized, double-blind, placebo-controlled trial was conducted in China by Sagimet’s partner, Ascletis Bioscience. It enrolled 480 patients with Investigator’s Global Assessment (IGA) scores of 3 or 4. Patients were randomized to receive either denifanstat 50 mg or a placebo once daily for 12 weeks. Primary endpoints included treatment success (an IGA score of 0 or 1 with at least a 2-point decrease), percentage change in total lesion count, and percentage change in inflammatory lesion count. The drug was reported to be generally well-tolerated.
“FASN inhibition represents a novel mechanism of action for the treatment of acne, a condition that impacts more than 50 million people in the US annually, with limited innovation over the last 40 years,” says David Happel, chief executive officer of Sagimet, in a release.
Sagimet has also initiated a Phase 1 first-in-human clinical trial in the US for a second FASN inhibitor, TVB-3567. The company plans to develop TVB-3567 as a new therapeutic option for patients with moderate to severe acne.
ID 38849629 | Acne © Evgenyatamanenko | Dreamstime.com
