Dosing has successfully commenced with healthy volunteersPrimary endpoints for the Phase 1 trial include safety, tolerability, and pharmacokinetic (PK) profile of the combinationTopline data are anticipated in the first half of 2026 SAN MATEO, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that the Company has dosed the ...

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on denifanstat for treating metabolic dysfunction associated steatohepatitis (MASH), with promising results from recent clinical trials and plans for further studies [2][5]. Clinical Development - The Phase 2b FASCINATE-2 trial of denifanstat in MASH patients showed successful results, especially in F3 stage patients [2]. - Denifanstat demonstrated similar pharmacokinetic characteristics and tolerability in a Phase 1 trial for patients with and without hepatic impairment [2]. - A Phase 1 clinical trial to evaluate the combination of denifanstat and resmetirom is anticipated to start in the second half of 2025, with results expected in the first half of 2026 [3][12]. Preclinical Data - Preclinical data presented at EASL 2024 indicated that the combination of a FASN inhibitor (TVB-3664) and resmetirom significantly improved liver disease markers, achieving an 80% improvement in NAS compared to 33% and 25% improvements from monotherapies [3][6]. Financial Results - For the quarter ended March 31, 2025, Sagimet reported a net loss of $18.2 million, compared to a net loss of $6.6 million for the same period in 2024 [8][16]. - Research and development expenses increased to $15.3 million from $5.3 million year-over-year, while general and administrative expenses rose to $4.5 million from $3.5 million [12][16]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $144.6 million [12][17]. Corporate Updates - The company successfully completed end-of-Phase 2 interactions with the FDA in October 2024, paving the way for Phase 3 trials in MASH [5]. - Leadership changes include George Kemble transitioning to non-executive Chair of the Board and the appointment of Beth Seidenberg as Lead Independent Director [5]. Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [10]. - The renaming of NAFLD to MASLD and NASH to MASH aims to reduce stigma and improve diagnosis [10].