developing novel fatty acid synthase (FASN) inhibitors that are designed to treat dysfunctional metabolic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. We are also exploring the use of our FASN inhibitors, which include our lead product candidate 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.
Our lead product candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), formerly known as nonalcoholic steatohepatitis (NASH). FASCINATE-1, our Phase 2 clinical trial in patients with MASH, showed that denifanstat was well-tolerated with a favorable pharmacokinetic profile. We announced the successful completion of FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, in January 2024.
Stage of Development
Therapeutic area
Indication
Preclinical
Phase 1
Phase 2
Phase 3
* Trials conducted in China by Ascletis, who has licensed development and commercialization rights to all indications in Greater China
Stage of Development
Therapeutic area
Indication
Expected milestone
Preclinical
Phase 1
Phase 2
Phase 3
** Moderate to advanced fibrosis
** Trials conducted in China by Ascletis, who has licensed development and commercialization rights to all indications in Greater China
Denifanstat was well-tolerated and met primary endpoint in planned interim readout with 67% of treated patients achieving ≥30% reductions in liver fat at week 26 compared to 18% placebo (p<0.001)
San Mateo, Calif., June 7, 2023 – Sagimet Biosciences Inc., a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic pathways, today announced that it will present interim data from the
Denifanstat Showed Statistically Significant Improvements Across Key Disease Markers in FASCINATE-2 Study After 26 Weeks of Treatment Highlights to be Included in Oral Presentation Session at The Liver Meeting on
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