About
Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. FASN is a regulator of lipid synthesis and a key pathway implicated in multiple diseases, such as metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH), acne and select forms of cancer.
Our lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. We announced positive topline results for FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, in January 2024. In October 2024, the FDA granted Breakthrough Therapy designation to denifanstat for the treatment of noncirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis).
FASCINATE-2 was a Phase 2b clinical trial of denifanstat in biopsy-confirmed MASH patients with moderate to advanced fibrosis (F2/F3) at week 52. In this trial, denifanstat, an oral, selective FASN inhibitor, showed statistically significant improvements relative to placebo on both of the primary endpoints of MASH resolution without worsening of fibrosis with ≥2-point reduction in NAS, and ≥2-point reduction in NAS without worsening of fibrosis.
Denifanstat-treated patients also showed statistically significant fibrosis improvement by ≥ 1 stage with no worsening of MASH, and a greater proportion of MRI-derived proton density fat fraction (MRI-PDFF) ≥30% responders relative to placebo.
Danifanstat impacts key drivers of MASH
In addition to MASH, we are exploring the use of our FASN inhibitors, which include denifanstat and our pipeline product candidate, TVB-3567, in acne and in select forms of cancer, disease areas in which dysregulation of fatty acid metabolism also plays a key role.Â
Acne
Denifanstat is currently being tested in China in moderate to severe acne vulgaris by our license partner Ascletis Bioscience Co. Ltd (Ascletis), in a Phase 3 clinical trial. Â In November 2024, Ascletis announced completion of enrollment of 480 patients in the acne Phase 3 clinical trial and that it expects to announce topline results in the second quarter of 2025.
In March 2025, we announced the clearance of our Investigational New Drug (IND) application for a first-in-human Phase 1 clinical trial of our second FASN inhibitor, TVB-3567. TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. The IND clearance allows us to initiate a first-in-human Phase 1 clinical trial of TVB-3567 for development of an acne indication, which we expect to initiate in the second half of 2025.
Cancer
Denifanstat is currently being tested in China by Ascletis in a Phase 3 clinical trial in recurrent glioblastoma multiforme (GBM) in combination with bevacizumab.
*Sagimet is derived from a combination of Sagitta and metabolism. In Greek mythology, Sagitta is the arrow used to stop the eagle sent by Zeus to perpetually gnaw on Prometheus’ liver as punishment for gifting fire to humans. Our therapeutic focus targets dysfunctional metabolic pathways.
