Sagimet Biosciences (SGMT) reported that denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimets license partner Ascletis Bioscience in China. Denifanstat is a once-daily oral small molecule fatty acid synthase inhibitor being developed by Ascletis as ASC40 for acne in China and by Sagimet for MASH in the rest of world.
Ascletis has indicated that it plans to submit denifanstat for approval to the China National Medical Products Administration. Building on Ascletis positive Phase 3 results, Sagimet has initiated a Phase 1 first-in-human clinical trial with a second oral FASN inhibitor drug candidate, TVB-3567, that is planned to be developed for acne in the U.S.
Shares of Sagimet are up 45% in pre-market trade on Wednesday.
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