Sagimet Biosciences Presents Clinical Denifanstat and Preclinical FASN Inhibitor Data at AASLD - The Liver Meeting® 2024

$SGMT
Biotechnology: Pharmaceutical Preparations
Health Care
Get the next $SGMT alert in real time by email

Subset analysis of FASCINATE-2 Phase 2 trial demonstrated denifanstat improved fibrosis in difficult-to-treat MASH patients

Both artificial intelligence (AI) and conventional pathology demonstrated denifanstat's strong anti-fibrotic activity

FASN inhibitor treatment reduced atherosclerosis development in mouse model of dyslipidemia and MASH

SAN MATEO, Calif., Nov. 18, 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 the presentation of Phase 2b data demonstrating the anti-fibrotic activity of its fatty acid synthase (FASN) inhibitor denifanstat, and preclinical data demonstrating potential benefit of FASN inhibition in atherosclerosis, at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting 2024®, November 15-19, 2024 in San Diego, California.

"Our presentations of data from the Phase 2b FASCINATE-2 study highlight denifanstat's impact on liver fibrosis, particularly in difficult-to-treat subsets of MASH patients who are at the highest risk of disease progression," said Dave Happel, Chief Executive Officer of Sagimet. "Using an AI-based digital pathology approach, we observed pronounced fibrosis reduction in the peri-portal and portal zones of the liver, which as part of composite scores have recently been shown to correlate with liver outcomes and mortality, that may not be captured using conventional histological scoring. Finally, our preclinical data in a mouse model of MASH and dyslipidemia treated with a FASN inhibitor that is a surrogate for denifanstat showed that a FASN inhibitor may reduce circulating cholesterol and atherosclerosis development. Together, these results demonstrate the anti-fibrotic effects and potential cardiometabolic benefits of FASN inhibition and support the advancement of denifanstat into Phase 3 development."

A poster titled "Denifanstat significantly improves liver fibrosis in difficult-to-treat MASH patients – Results from conventional and AI-based pathology from the phase 2b FASCINATE-2, a 52-week randomized, double-blind, placebo-controlled trial," was presented by 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, the primary investigator of the FASCINATE-2 trial. Denifanstat treatment improved fibrosis by ≥ 1 stage without worsening of MASH in the higher-risk patient subgroups described below. Observed improvements by conventional pathology reading included:

  • F3 population: 49% denifanstat (n=47) vs 13% placebo (n=23) (p=0.0032)
  • GLP1 receptor agonist population: 42% denifanstat (n=12) vs 0% placebo (n=4) (p=0.034)
  • Type 2 diabetes population: 40% denifanstat (n=55) vs 19% placebo (n=27) (p=0.0382)
  • PNPLA3 I148 carrier population: 30% denifanstat (n=33) vs 6% placebo (n=17) (p=0.022)

Strong consistency in fibrosis improvement was observed between conventional and AI-based pathology in the F3 population. Denifanstat treatment improved fibrosis by ≥ 1 stage in more than 50% of F3 patients as follows:

  • AI-based: 62% denifanstat (n=47) and 26% placebo (n=23) (p=0.005)
  • Conventional: 55% denifanstat (n=47) and 26% placebo (n=23) (p=0.021)

An oral presentation titled "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," was presented by Mary Rinella, M.D. (University of Chicago). In this analysis, second harmonic generation (SHG) microscopy AI-based digital pathology was used to evaluate pre- and post-treatment liver biopsies. Denifanstat showed statistically significant liver fibrosis improvement, particularly in the portal and peri-portal regions. Improvement was observed with AI-based digital pathology not only in patients with >1-stage fibrosis improvement but also in patients with "no change" in fibrosis stage by conventional reading, representing important mechanistic insights provided by the AI-based platform. Select fibrosis parameters in the periportal and portal regions are part of AI-based composite score that have been recently linked to liver outcomes and mortality. Overall, both AI and conventional pathology readings demonstrated denifanstat's strong anti-fibrotic activity in MASH patients, including those with high risk of progression. These data reflect the unique mechanism of action of denifanstat and support the initiation of phase 3 trials.

Lastly, a poster titled "Fatty acid synthase (FASN) inhibitor reduces atherosclerosis development in diet-induced dyslipidaemia LDL receptor knockout mice with MASH," was presented by Wen-Wei Tsai, Ph.D. (Sagimet Biosciences). In this mouse model, treatment with a FASN inhibitor that is a preclinical surrogate for denifanstat rapidly reduced circulating cholesterol, triglycerides and inflammatory markers associated with atherosclerosis, including CCL4 and CXCL2. The FASN inhibitor also reduced total atherosclerotic lesion area in the aortic root and improved liver steatosis, inflammation and fibrosis. These preclinical results suggest that a FASN inhibitor such as denifanstat could potentially provide benefits in cardiovascular as well as liver health, supporting the clinical evaluation of denifanstat for long term outcomes in MASH patients.

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 Phase 3 development in MASH. 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 to improve diagnostic clarity.

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



Primary Logo

Get the next $SGMT alert in real time by email

Chat with this insight

Save time and jump to the most important pieces.

Recent Analyst Ratings for
$SGMT

DatePrice TargetRatingAnalyst
12/6/2024$30.00Outperform
Oppenheimer
11/12/2024$12.00Buy
UBS
6/28/2024$23.00 → $6.00Buy → Neutral
Goldman
5/2/2024$32.00Buy
H.C. Wainwright
3/25/2024$26.00Outperform
Leerink Partners
8/8/2023Outperform
TD Cowen
8/8/2023$67.00Overweight
Piper Sandler
8/8/2023$33.00Buy
Goldman
More analyst ratings

$SGMT
Press Releases

Fastest customizable press release news feed in the world

See more
  • Sagimet Biosciences Announces Clearance of IND for FASN Inhibitor TVB-3567, to be Developed for the Treatment of Acne

    TVB-3567 is the Company's second fatty acid synthase (FASN) inhibitor First-in-human Phase 1 trial initiation planned in 2025 SAN MATEO, Calif., March 11, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. ((Sagimet, NASDAQ:SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced the clearance of its Investigational New Drug (IND) application for TVB-3567, the Company's second fatty acid synthase (FASN) inhibitor. TVB-3567 is a potent and selective small molecule FASN inhibitor, planned to enter clinical development for the treatment of acne. The IND with the U.S. Food and Drug Administration's

    $SGMT
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Sagimet Biosciences Announces Oral Presentation at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium

    SAN MATEO, Calif., Feb. 19, 2025 (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 an oral presentation on denifanstat's effect on triglycerides and LDL-cholesterol in advanced fibrosis patients will be delivered at the MASH Pathogenesis and Therapeutic Approaches Keystone Symposium being held February 23-26, 2025 in Banff, Canada. The presentation will feature lipidomic data from a post-hoc analysis of the Phase 2b FASCINATE-2 trial of denifanstat in MASH. MASH Pathogenesis and Therapeutic Approaches Keystone Symp

    $SGMT
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Sagimet Biosciences Announces Oral Presentation at the 9th Annual MASH-TAG 2025 Conference

    SAN MATEO, Calif., Jan. 06, 2025 (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 an oral presentation highlighting fatty acid synthase (FASN) inhibitors will be given at the upcoming 9th Annual MASH-TAG Conference being held January 9-11, 2025 in Park City, Utah. The presentation will focus on the differentiated mechanism of action of the FASN inhibitor denifanstat and the observed anti-fibrotic effect in the Phase 2b FASCINATE-2 study in F2/F3 MASH. MASH-TAG 2025 Presentation Details: Title:FASN InhibitorsPresen

    $SGMT
    Biotechnology: Pharmaceutical Preparations
    Health Care

$SGMT
Analyst Ratings

Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.

See more

$SGMT
Insider Purchases

Insider purchases reveal critical bullish sentiment about the company from key stakeholders. See them live in this feed.

See more

$SGMT
Insider Trading

Insider transactions reveal critical sentiment about the company from key stakeholders. See them live in this feed.

See more

$SGMT
SEC Filings

See more

$SGMT
Leadership Updates

Live Leadership Updates

See more
  • Sagimet Biosciences Announces Appointment of Thierry Chauche as Chief Financial Officer

    SAN MATEO, Calif., May 06, 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 the appointment of Thierry Chauche as Chief Financial Officer, effective today, May 6, 2024. "We are thrilled to welcome Thierry to our executive leadership team in the role of CFO. Thierry brings a proven track record in corporate finance in the biopharmaceutical sector, bringing expertise in corporate planning and strategy, investor relations, financing, and M&A," said Dave Happel, CEO of Sagimet. "Having an

    $SGMT
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • Sagimet Biosciences Announces Appointment of Tim Walbert and Paul Hoelscher to its Board of Directors

    SAN MATEO, Calif., March 25, 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 the appointments of two biotechnology industry leaders, Tim Walbert and Paul Hoelscher, to the board of directors of the Company, effective April 1, 2024. "We are fortunate to have Tim and Paul join us at this key stage as we prepare to initiate a pivotal, Phase 3 trial for our lead candidate denifanstat in MASH in the second half of 2024," said Dave Happel, CEO of Sagimet. "With his experience as CEO of publi

    $IPSC
    $MIRM
    $RPHM
    $SGMT
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Biotechnology: Pharmaceutical Preparations

$SGMT
Financials

Live finance-specific insights

See more
  • Sagimet Biosciences Reports Second Quarter 2024 Financial Results and Provides Corporate Updates

    Denifanstat Phase 2b FASCINATE-2 clinical trial 52-week data was presented in June at the European Association for the Study of the Liver (EASL) Congress Preparations are ongoing to initiate a Phase 3 clinical development program for denifanstat in patients with metabolic dysfunction-associated steatohepatitis (MASH) in the second half of 2024 Two biotechnology industry leaders, Anne Phillips and Jennifer Jarrett, joined the Board of Directors effective August 1, 2024 Anticipated cash runway through 2025 with cash, cash equivalents and marketable securities totaling $188.5 million as of June 30, 2024 SAN MATEO, Calif., Aug. 14, 202

    $SGMT
    Biotechnology: Pharmaceutical Preparations
    Health Care
  • 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 advi

    $SGMT
    Biotechnology: Pharmaceutical Preparations
    Health Care

$SGMT
Large Ownership Changes

This live feed shows all institutional transactions in real time.

See more