Sagimet Biosciences to Host Virtual KOL Event, "Evaluating the Synergistic Potential of a Combination of Denifanstat and Resmetirom for the Treatment of Metabolic Dysfunction-Associated Steatohepatitis (MASH)" on May 29, 2025
SAN MATEO, Calif., May 22, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced it will host a virtual key opinion leader (KOL) event on Thursday, May 29, 2025 at 1:00 PM ET. To register, click here.
The event will feature Rohit Loomba, MD, MHSc (Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego), who will join company management to discuss the potential for developing a combination of denifanstat, a fat synthesis inhibitor, with a fat oxidizer, such as resmetirom, a thyroid hormone beta receptor agonist, to treat advanced metabolic dysfunction-associated steatohepatitis (MASH). The planned development program builds upon the successful results of the Phase 2b FASCINATE-2 clinical trial of denifanstat in MASH F2-F3 patients, particularly in more advanced F3 stage patients, as well as on preclinical data demonstrating the synergistic effect of a FASN inhibitor combined with resmetirom on important liver disease markers.
The event will provide an overview of the planned Phase 1 pharmacokinetic clinical trial of the denifanstat and resmetirom combination, and a discussion on the potential benefits of combination therapy to treat patients living with advanced MASH. Denifanstat, Sagimet's lead product candidate, is an oral, once daily selective fatty acid synthase (FASN) inhibitor in development for the treatment of MASH, whose strong anti-fibrotic mechanism of action coupled with its inhibition of liver fat synthesis may be complementary to a fat oxidizer molecule such as resmetirom. Pre-clinical data presented at EASL in 2024 for two mouse models of MASH showed that the combination of a FASN inhibitor (TVB-3664, a surrogate for denifanstat) and resmetirom had a synergistic effect on important markers of liver disease, including improvement of NAS (NAFLD Activity Score) by histologic analysis and more robust improvement in hepatic collagen content compared to the single agents.
A live question and answer session will follow the formal presentations. A replay of this event will be available in the Investors & Media section of Sagimet's website at www.sagimet.com for 90 days following the live event.
About Rohit Loomba, MD, MHSc
Rohit Loomba, MD, MHSc is a board-certified gastroenterologist and serves as the Chief, Division of Gastroenterology and Hepatology at University of California at San Diego. He is also the founding director of the UCSD MASLD Research Center. His expertise includes treating and managing many types of chronic liver disease, such as metabolic dysfunction-associated steatotic liver disease (MASLD), nonalcoholic steatohepatitis, chronic hepatitis, cirrhosis, and hemochromatosis. As a transplant hepatologist, Dr. Loomba works with transplant surgeons in the pre and postoperative care of liver transplant patients. As a professor in the Division of Gastroenterology, Dr. Loomba instructs students, residents and fellows in the Department of Medicine at UC San Diego School of Medicine. His research focuses on all aspects of MASLD, including prevalence in aging, epidemiology, genetic and environmental predisposition and progression. Dr. Loomba is the founding director of the UCSD MASLD Research Center where a multi-disciplinary team of researchers are conducting cutting edge research in all aspects of MASLD including non-invasive biomarkers, genetics, epidemiology, clinical trial design, imaging end-points, and integrated OMICs using microbiome, metabolome and lipidome. This integrated approach has led to several innovative applications such as establishment of MRI-PDFF as a non-invasive biomarker of treatment response in early phase trials in MASH, which has now been adopted in more than a hundred clinical trials conducted worldwide. He holds several patents on non-invasive biomarkers of MASH and fibrosis. His research is funded by the National Institutes of Health as a Principal Investigator including two R01s, three U01 (two NIDDK and one from NIAAA), clinical core director of P30 (NIDDK) and project director P01 (NHLBI) grant mechanisms, Foundation of NIH, as well as several large multicenter, multi-million dollar investigator initiated research projects funded by the industry. He is the Principal Investigator, UCSD, for the NIDDK-sponsored MASH Clinical Research Network and the Liver Cirrhosis Network. Dr. Loomba has published more than 500 peer-reviewed manuscripts in his field. He is an elected member of the American Society of Clinical Investigation and the Association of American Physicians.
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 metabolic dysfunction associated steatohepatitis (MASH). FASCINATE-2, a Phase 2b clinical trial of denifanstat in MASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Denifanstat has been granted Breakthrough Therapy designation by the FDA for the treatment of non-cirrhotic MASH with moderate to advanced liver fibrosis (consistent with stages F2 to F3 fibrosis), and end-of-Phase 2 interactions with the FDA have been successfully completed, supporting the advancement of denifanstat into further development. Sagimet's second FASN inhibitor, TVB-3567, a potent and selective small molecule FASN inhibitor, received IND clearance in March 2025, allowing initiation of a first-in-human Phase 1 clinical trial for a potential acne indication. For additional information about Sagimet, please visit www.sagimet.com.
About MASH
Metabolic-dysfunction associated steatohepatitis (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; 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
[email protected]
Media Contact:
Michael Fitzhugh
LifeSci Advisors
[email protected]
