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Sagimet Biosciences to Host Conference Call and Webcast to Discuss Recently Presented Data from ITT and F3 Patient Population in Phase 2b FASCINATE-2 Clinical Trial of Denifanstat

SAN MATEO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Sagimet, Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors designed to target dysfunctional metabolic and fibrotic pathways, today announced that it will host a conference call and webcast on Thursday, June 13, 2024, at 9.30 AM PT / 12:30 PM ET.

The event will feature Rohit Loomba, M.D., M.H.Sc., Professor of Medicine, Chief, Division of Gastroenterology and Hepatology, and Director, MASLD Research Center, University of California San Diego, who was the Principal Investigator on the Phase 2b FASCINATE-2 clinical trial and serves as a scientific advisor for Sagimet on its ongoing development of denifanstat.

Dr. Loomba will discuss positive data from Sagimet’s FASCINATE-2 Phase 2b clinical trial of denifanstat versus placebo in biopsy-confirmed metabolic dysfunction-associated steatohepatitis (MASH) patients which he recently presented at the European Association for the Study of the Liver (EASL) Congress in Milan, Italy. Sagimet’s lead drug candidate, denifanstat, is an oral, once-daily pill and selective FASN inhibitor in development for the treatment of MASH.

Participants will have the opportunity to participate in a chat-based Q&A session.

Conference Call and Webcast Information
The live webcast and replay may be accessed by visiting the Sagimet website here. The dial-in number is 1-877-407-0779 (U.S./Canada) or 1-201-389-0914 (international). The conference ID for all callers is 13747107.

The Call me™ link may be accessed here. Participants can use guest dial-in numbers above and be answered by an operator or they can click the Call me™ link for instant telephone access to the event (dial-out). The Call me™ link will be made active 15 minutes prior to scheduled start time.

About Rohit Loomba, MD

Rohit Loomba, MD, M.H.Sc., is a board-certified gastroenterologist. 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. He has been continuously listed among the top 0.1% percent of highly cited scientists across fields of sciences.

Dr. Loomba’s disclosure of conflicts of interest (COI) can be found in the EASL presentation which is available in the Posters & Publications section of Sagimet’s website at www.sagimet.com.

About the Phase 2b FASCINATE-2 Clinical Trial

The Phase 2b FASCINATE-2 clinical trial was a 52-week randomized, double-blind, placebo-controlled trial that evaluated the safety and histological impact of denifanstat compared to placebo in 168 biopsy-confirmed MASH patients with moderate-to-severe fibrosis (stage F2 or F3) with NAS ≥4. Patients were randomized 2:1 to receive 50 mg denifanstat or placebo, taken orally once daily. An end-of-trial biopsy was assessed by a central pathologist for histological endpoints. Liver biopsies were also analyzed using AI-based digital pathology.

About Sagimet Biosciences

Sagimet is a clinical-stage biopharmaceutical company developing novel fatty acid synthase (FASN) inhibitors that are designed to target dysfunctional metabolic 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 metabolic dysfunction-associated steatohepatitis (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, 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 


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