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Sagimet Biosciences Presents Data from ITT and F3 Patient Population in Phase 2b FASCINATE-2 Clinical Trial of Denifanstat at EASL International Liver Congress 2024
Denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints in the ITT population, including both histology
About this update from Sagimet Biosciences Inc. - Series A
[{"type":"text","content":"Denifanstat achieved statistically significant results on primary and secondary liver biopsy endpoints in the ITT population, including both histology endpoints recommended in the FDA draft guidance for accelerated approval in MASH Denifanstat showed a statistically significant improvement in liver fibrosis ≥1-stage without worsening of MASH in the ITT population, including in patients with baseline stage 3 fibrosis Statistical significance also shown in improvement of liver fibrosis ≥2-stage without worsening of MASH in the mITT population, including in patients with baseline stage 3 fibrosis Tripalmitin, a biomarker of denifanstat activity, showed an early and sustained reduction in de novo lipogenesis at 4-weeks Safety in the ITT population showed denifanstat was generally well tolerated Management to host live webcast with Principal Investigator Dr. Rohit Loomba at 9:30 AM PT (12:30 PM ET) on Thursday, June 13, 2023 SAN MATEO, Calif., June 06, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, presented positive data from its FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients at the European Association for the Study of the Liver (EASL) Congress being held in Milan, Italy. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH. “Our presentation of the FASCINATE-2 study data shows the strong impact of denifanstat, a novel therapeutic designed to reduce the three main drivers of MASH - fat accumulation, inflammation, and fibrosis. The week 52 data on the improvement of fibrosis both by ≥ 1 and ≥ 2 stages, particularly in the F3 patient population, are very encouraging and differentiate denifanstat,” said Dave Happel, Chief Executive Officer of Sagimet. “Our focus now shifts to initiating our Phase 3 registrational program for the development of denifanstat in MASH with fibrosis in the second half of this year.” Positive top line data was announced for the FASCINATE-2 Phase 2b study on January 22, 2024 (here). In the EASL presentation, additional 52-week ITT ...