Company Announcements

SAN MATEO, Calif., Oct. 16, 2024 (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 Phase 2b data demonstrating the anti-fibrotic activity of its fatty acid synthase (FASN) inhibitor, denifanstat, and preclinical data demonstrating atherosclerosis improvement with FASN inhibitor treatment, will be highlighted in three presentations at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting^® 2024, taking place November 15-19, 2024 in San Diego, California.

Details of accepted abstracts can be found below:

Oral Presentation:

Title:	AI-based digital pathology shows that denifanstat improves multiple parameters of fibrosis and reduces progression to cirrhosis in MASH patients with F2/F3 fibrosis – results of the FASCINATE-2 study
Session:	MASLD and MASH - New Therapies
Date/Time:	Sunday, November 17 at 2:45pm PT
Location:	San Diego Convention Center, Poster Hall
Presenting author:	Mary Rinella, M.D., University of Chicago

Denifanstat, an oral FASN inhibitor, demonstrated statistically significant MASH resolution and fibrosis improvement and decreased liver fat and biomarkers of inflammation and fibrosis in the Phase 2b study FASCINATE-2. AI digital pathology results confirm denifanstat’s reduction of liver fibrosis and steatosis in MASH shown in the FASCINATE-2 study.

Poster Presentations:

Title:	Fatty acid synthase (FASN) inhibitor reduces atherosclerosis development in diet-induced dyslipidaemia LDL receptor knockout mice with MASH
Session:	MASLD/MASH - Experimental: Basic
Date:	Friday, November 15
Location:	San Diego Convention Center, Poster Hall
Presenting author:	Wen-Wei Tsai, Ph.D., Sagimet Biosciences

In a mouse model of dyslipidaemia and MASH, FASN inhibition by denifanstat not only reduced circulating cholesterol, but also decreased the development of atherosclerosis and improved liver histology. These results suggest that denifanstat, once approved, could potentially offer benefits in both cardiovascular and liver health benefits to patients and support its future clinical evaluation for long term outcomes in MASH patients.

Title:	Denifanstat significantly improves liver fibrosis in difficult-to-treat metabolic dysfunction-associated steatohepatitis (MASH) patients. Results from conventional and AI-based pathology from the Phase 2b FASCINATE-2, a 52-week randomized, double blind, placebo-controlled trial of fatty acid synthase (FASN) inhibitor denifanstat, in F2/F3 MASH
Session:	MASLD/MASH - Therapeutics: New Agents
Date:	Sunday, November 17
Location: Presenting author:	San Diego Convention Center, Poster Hall Rohit Loomba, M.D., M.H.Sc., University of California San Diego

Denifanstat’s impact on fibrosis in the overall Phase 2b study population as well as in difficult-to-treat subsets was evaluated by conventional histopathology and second harmonic generation AI-based digital pathology. Denifanstat demonstrated statistically significant improvement in liver fibrosis without worsening of MASH, including 2-stage fibrosis improvement in difficult-to-treat MASH.

About Sagimet Biosciences

Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic and fibrotic pathways in diseases resulting from the overproduction of the fatty acid, palmitate. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH. FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. 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 115 million people worldwide, for which there is only one recently approved treatment in the United States and no currently approved treatments in Europe. In 2023, global liver disease medical societies and patient groups formalized the decision to rename non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH. Additionally, an overarching term, steatotic liver disease (SLD), was established to capture multiple types of liver diseases associated with fat buildup in the liver. The goal of the name change was to establish an affirmative, non-stigmatizing name and diagnosis.

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 anticipated development milestones, Sagimet’s cash and financial resources and expected cash runway. 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 or any other drug candidates Sagimet may develop; Sagimet’s ability to advance drug candidates into and successfully complete clinical trials within anticipated timelines, including its Phase 3 denifanstat program; 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.

Contact:
Joyce Allaire 
LifeSci Advisors 
jallaire@lifesciadvisors.com