1. Sagimet reports positive Phase 1 results for denifanstat and resmetirom combination. 2. Combination therapy showed good tolerability with no serious adverse events. 3. Phase 2 trial targeting MASH cirrhosis (F4) is anticipated in 2H 2026. 4. EASLD presentations underscored denifanstat's effectiveness in advanced fibrosis patients. 5. Recent licensing agreement with TAPI may enhance future development efforts.
FAQ
Why Bullish?
Positive trial results and advancements in therapeutic development can boost investor confidence, as seen with other biopharmaceutical companies achieving similar milestones.
How important is it?
The ongoing clinical developments and their potential market implications significantly affect SGMT's stock trajectory as it directly involves its lead compound denifanstat.
Why Long Term?
The anticipated Phase 2 trial outcomes could significantly influence SGMT’s market position and stock value over time, similar to how product approval timelines affect biopharma stocks.
Sagimet Biosciences Reports Promising Phase 1 Trial Results for Denifanstat and Resmetirom Combination
Stock Symbol: SGMT
Release Date: December 18, 2025
Source: GlobeNewsWire
Overview of Results
Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company focused on innovative treatments for metabolic and fibrotic diseases, announced positive outcomes from its Phase 1 pharmacokinetic (PK) trial involving the combination of denifanstat and resmetirom. The study’s results, which are pivotal for future development, showed a well-tolerated safety profile, paving the way for a planned Phase 2 trial in patients with fibrosis stage F4 metabolic dysfunction-associated steatohepatitis (MASH) to initiate in the second half of 2026.
Details of the Phase 1 Trial
The Phase 1 trial (NCT07216313) was an open-label, 2-cohort study involving 40 healthy adult participants. The objectives were to assess the multiple-dose and single-dose pharmacokinetics, evaluate potential drug-drug interactions (DDIs), and examine the safety and tolerability of the combination.
The findings confirmed that the denifanstat and resmetirom combination was generally well-tolerated, showing no significant safety signals. Importantly:
- No Serious Adverse Events (SAEs) were reported.
- Clinically significant laboratory results were absent.
- There were no treatment discontinuations.
Future Development Plans
Building on these encouraging Phase 1 results, Sagimet intends to move forward with a Phase 2 proof-of-concept efficacy trial targeting patients suffering from MASH with F4 fibrosis. This progression is contingent upon further discussions with regulatory authorities.
“The successful completion of the Phase 1 PK trial is an important step in our journey to develop a new, potentially synergistic combination treatment for MASH. Patients with cirrhosis of the liver associated with MASH currently have no approved options and our goal is to combine two therapies with complementary mechanisms of action into a single tablet to address this underserved medical need,” stated David Happel, CEO of Sagimet.
In addition, Sagimet recently formed a global licensing agreement with TAPI, a TEVA affiliate, to leverage innovative formulations of resmetirom for developing a convenient, once-daily pill combination product targeted for patients with liver cirrhosis.
About Denifanstat and Resmetirom
Denifanstat serves as Sagimet’s cornerstone product candidate, operating as an oral, once-daily selective fatty acid synthase (FASN) inhibitor aimed at treating MASH. It functions through an anti-fibrotic mechanism while inhibiting liver fat production and inflammation. This mode of action is expected to complement resmetirom, a thyroid hormone receptor beta (THR-β) agonist already available as Rezdiffra for non-cirrhotic MASH cases.
Pre-clinical studies presented earlier at EASL 2024 indicated that the combination of a FASN inhibitor and resmetirom provided synergistic benefits regarding critical liver disease markers, highlighting improved outcomes such as:
- Enhanced NAFLD Activity Score (NAS) through histological analysis.
- Significantly better improvement in hepatic collagen content compared to single agents.
Understanding MASH
MASH is a severe and progressive liver condition, impacting over 265 million people globally. It is characterized by fat accumulation in the liver and can lead to inflammation and fibrosis, alongside metabolic abnormalities such as dyslipidemia and insulin resistance. Those with advanced fibrosis (F3) or cirrhosis (F4) face the highest risks of severe liver complications, including decompensation, hepatocellular carcinoma, and the necessity for liver transplantation. Presently, there are limited approved treatments available for MASH, with an especially notable void for F4-stage cirrhotic patients.