Phase 1 clinical data poster selected as a Best of EASL 2026 presentation
Combination of denifanstat and resmetirom was generally well-tolerated in Phase 1 clinical trial
Phase 1 data show rapid reductions in cholesterol levels, suggesting the potential for a cardiovascular benefit
SAN MATEO, Calif., May 27, 2026 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced the presentation of two posters at the European Association for the Study of the Liver (EASL) Annual Congress 2026, being held in Barcelona, Spain on May 27-30, 2026. The Late-Breaking denifanstat/resmetirom poster, covering Phase 1 clinical data on the combination of Sagimet's oral once-daily fatty acid synthase (FASN) inhibitor, denifanstat, and resmetirom, a thyroid hormone receptor beta (THR-β) agonist, was selected as a Best of EASL 2026 presentation. A second poster presents preclinical data on the combination's mechanism of action.
EASL Poster Presentation Details:
Selected for Best of EASL 2026: Denifanstat and resmetirom combination therapy rapidly decreased atherogenic lipids in healthy adults in Phase 1 open-label trial
- Presenter: Mary E. Rinella, MD, University of Chicago
- Session: LBP-032
- Date: Wednesday to Saturday, May 27-30, 2026
- Author attending: Friday, May 29th 12:45 to 1:45 PM CEST
- Location: Fira Barcelona, Spain
Poster Highlights:
This Phase 1 trial built on preclinical data showing that the combination of a FASN inhibitor and resmetirom improved liver histology versus monotherapy through complementary mechanisms of liver fat reduction and denifanstat’s direct anti-fibrotic effect.
The Phase 1 open label clinical trial evaluated the safety, pharmacodynamics, and pharmacokinetics of the denifanstat/resmetirom combination in 40 healthy adults with a mean BMI of 30-32 kg/m2. Two cohorts assessed different dosing sequences: subjects received 7 days of monotherapy followed by 7 days of combination therapy. Cohort 1 initiated monotherapy with denifanstat and Cohort 2 with resmetirom. Denifanstat was dosed at 50 mg and resmetirom utilized weight-based dosing (80 or 100 mg).
Topline safety data reported in December 2025 showed that the combination of denifanstat and resmetirom was generally well-tolerated over the duration of the study, with no safety signals. Clinical data reported for the first time at EASL 2026 show rapid reduction in total and LDL cholesterol levels (p<0.001) after two weeks of treatment, suggesting a potential cardiovascular benefit:
- Cohort 1 (denifanstat followed by denifanstat/resmetirom): total cholesterol -23mg/dl, LDL cholesterol -17mg/dl
- Cohort 2 (resmetirom followed by denifanstat/resmetirom): total cholesterol -16mg/dl, LDL cholesterol -14mg/dl
Target engagement was demonstrated for both agents, with key pharmacodynamic biomarkers confirming the mechanism of action for each agent.
Together with prior clinical evidence of fibrosis improvement with each monotherapy, these results support the potential benefit of a denifanstat and resmetirom combination for MASH and liver fibrosis.
Poster Title: Transcriptomic analysis revealed distinct mechanisms underlying the synergistic effect of a fatty acid synthase (FASN) inhibitor and resmetirom combination in LDL receptor knockout MASH mice
- Presenter: Wen-Wei Tsai, PhD, Senior Director R&D, Translational Sciences, Sagimet Biosciences
- Session: SAT-227
- Date: Saturday, May 30, 2026
- Author attending: Saturday, May 30th 11:45 to 12:45 PM CEST
- Location: Fira Barcelona, Spain
Poster Highlights:
The combination of a FASN inhibitor and resmetirom showed greater improvements in liver histology and lipid lowering compared to monotherapy in mouse model of diet-induced MASH. Transcriptomic analysis further characterized the molecular mechanisms driving these effects, showing enhanced anti-inflammatory and anti-fibrotic activity and improved metabolic regulation including lipid and cholesterol synthesis.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company developing novel FASN inhibitors designed to target dysfunctional metabolic and fibrotic pathways in conditions 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 acne, MASH and certain FASN-dependent tumor types. For additional information about Sagimet, please visit www.sagimet.com.
About MASH
MASH is a progressive and severe liver disease which is estimated to impact more than 265 million people worldwide1. MASH is characterized by the build-up of fat in the liver and various degrees of inflammation and fibrosis along with systemic metabolic changes including dyslipidemia (increased fat levels in blood) and insulin resistance. Patients with moderate to severe disease who have advanced fibrosis (F3) or cirrhosis (F4) have the highest risk of liver-related outcomes such as decompensation, hepatocellular carcinoma, and liver transplantation. There are few approved treatments for non-cirrhotic MASH (stages F1, F2 and F3 fibrosis) and no approved treatments for MASH cirrhosis (F4).
1. Younossi ZM, et al. Hepatology. 2023;77(4): 1335-1347.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of, and made pursuant to the safe harbor provisions of, The Private Securities Litigation Reform Act of 1995. All statements contained in this press release, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding the expected timing of the presentation of data from ongoing clinical trials, Sagimet’s clinical development plans and related timelines and anticipated development milestones, are forward-looking statements. These statements involve known and unknown risks, uncertainties and other important factors that may cause Sagimet’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. In some cases, these statements can be identified by terms such as “may,” “might,” “will,” “should,” “expect,” “plan,” “aim,” “seek,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “forecast,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this press release are only predictions. Sagimet has based these forward-looking statements largely on its current expectations and projections about future events and financial trends that Sagimet believes may affect its business, financial condition and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Sagimet’s control, including, among others: the clinical development and therapeutic potential of denifanstat, TVB-3567 or any other drug candidates or combination therapies developed by Sagimet; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines; Sagimet’s relationship with Ascletis, and the success of its development efforts for denifanstat; the accuracy of Sagimet’s estimates regarding its capital requirements and Sagimet’s ability to maintain and successfully enforce adequate intellectual property protection. These and other risks and uncertainties are described more fully in the “Risk Factors” section of Sagimet’s most recent filings with the Securities and Exchange Commission and available at www.sec.gov. You should not rely on these forward-looking statements as predictions of future events. The events and circumstances reflected in these forward-looking statements may not be achieved or occur, and actual results could differ materially from those projected in the forward-looking statements. Moreover, Sagimet operates in a dynamic industry and economy. New risk factors and uncertainties may emerge from time to time, and it is not possible for management to predict all risk factors and uncertainties that Sagimet may face. Except as required by applicable law, Sagimet does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.
Investor Contact:
Joyce Allaire
LifeSci Advisors
JAllaire@LifeSciAdvisors.com
Media Contact:
Maggie Whitney
LifeSci Communications
mwhitney@lifescicomms.com
