Sagimet Biosciences announces clearance of IND for FASN inhibitor TVB-3567

Sagimet Biosciences (SGMT) announced the clearance of its Investigational New Drug, IND, application for TVB-3567, the Company’s second fatty acid synthase, FASN, inhibitor. TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. The IND with the U.S. Food and Drug Administration’s Division of Dermatology and Dentistry allows the Company to initiate a first-in-human Phase 1 clinical trial of TVB-3567, planned in 2025. “The clearance of the TVB-3567 IND marks a significant milestone for Sagimet, as we advance our second FASN inhibitor into the clinic and expand our therapeutic presence into dermatology,” said David Happel, Chief Executive Officer of Sagimet. “FASN inhibition is a highly attractive target in the treatment of acne, addressing acne’s most significant contributor, sebum. We are excited about bringing TVB-3567 into the clinic, building upon compelling data from the denifanstat program in acne, including the favorable sebum lipid composition changes demonstrated in the Phase 1 clinical trial conducted by Sagimet, and the significant decreases in inflammatory and non-inflammatory lesion counts after 12 weeks of treatment shown in a Phase 2 clinical trial conducted by our license partner Ascletis BioScience in patients with moderate to severe acne vulgaris in China. Based on both its mechanism of action and strong preclinical profile, we believe TVB-3567 has the potential to offer a differentiated treatment option for acne. We look forward to initiating enrollment of the first-in-human study of TVB-3567 in 2025.”