SAN MATEO, Calif., Oct. 07, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, today announced that analyses of the Phase 2b FASCINATE-2 study showing that denifanstat elicited fibrosis improvement in patients with advanced fibrosis will be presented at the American Association for the Study of Liver Disease (AASLD) - The Liver Meeting® 2025, taking place November ...

Dosing has successfully commenced with healthy volunteersPrimary endpoints for the Phase 1 trial include safety, tolerability, and pharmacokinetic (PK) profile of the combinationTopline data are anticipated in the first half of 2026 SAN MATEO, Calif., Oct. 01, 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 the Company has dosed the ...

Company Overview - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [3] - The company is developing fatty acid synthase (FASN) inhibitors, with its lead drug candidate, denifanstat, being an oral, once-daily pill for treating metabolic dysfunction associated steatohepatitis (MASH) [3] - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3] Clinical Trials and Developments - The FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH has been successfully completed with positive results [3] - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second oral FASN inhibitor, TVB-3567, which is planned for acne treatment in the U.S. [3] Upcoming Events - Sagimet will participate in a drug development panel at Fierce Biotech Week from October 7-9, 2025, in Boston, MA [1] - The panel titled "How Biotechs are Leveraging Artificial Intelligence (AI)/Machine Learning (ML) to Drive Efficiency and ROI" will feature Dr. Marie O'Farrell, Senior Vice President of Research and Development at Sagimet [2] - The discussion will focus on the application of AI in drug development, particularly how Sagimet employs AI-based digital pathology platforms to enhance clinical trials for MASH [2]

Core Insights - Sagimet Biosciences has reported that its lead drug candidate, denifanstat, has successfully met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris [2][3][4] Group 1: Clinical Trial Results - The Phase 3 clinical trial was a randomized, double-blind, placebo-controlled study involving 480 patients in China, assessing denifanstat at a dosage of 50 mg once daily for 12 weeks [3] - Denifanstat achieved an 18.6% placebo-adjusted increase in treatment success rate, a 22.0% placebo-adjusted reduction in total lesions, and a 20.2% placebo-adjusted reduction in inflammatory lesions [4] - The drug was generally well tolerated among participants [3][4] Group 2: Company Developments - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [5][7] - Denifanstat is also being developed for metabolic dysfunction associated steatohepatitis (MASH) and has received Breakthrough Therapy designation from the FDA for this indication [6] Group 3: Market Context - Acne affects over 50 million people annually in the U.S., with a significant market opportunity due to the chronic nature of the condition and the need for ongoing management [5][8] - The U.S. acne market includes approximately 5.1 million patients treated by dermatologists each year, highlighting the demand for innovative treatment options [8]

Core Insights - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways, specifically through fatty acid synthase (FASN) inhibitors [1][3] - The company will present two oral presentations and participate in a drug development panel at the 9th Annual MASH Drug Development Summit from September 29 to October 1, 2025, in Boston, MA [1] Presentation Details - The first presentation will be led by Dr. Marie O'Farrell, focusing on the mechanism of action of the FASN inhibitor denifanstat in combination with semaglutide or resmetirom, highlighting results from the Phase 2b FASCINATE-2 study [2] - The second presentation by Dr. Wen-Wei Tsai will discuss the anti-fibrotic effect of denifanstat in MASH patients with advanced fibrosis, utilizing AI-based digital pathology techniques [2] Company Overview - Sagimet's lead drug candidate, denifanstat, is an oral, once-daily selective FASN inhibitor aimed at treating metabolic dysfunction associated steatohepatitis (MASH) [3][4] - Denifanstat has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3][4] - The company has initiated a Phase 1 clinical trial for a second FASN inhibitor, TVB-3567, intended for acne treatment in the U.S. [4] Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited approved treatments available [5] - The renaming of non-alcoholic fatty liver disease (NAFLD) to metabolic dysfunction-associated steatotic liver disease (MASLD) and nonalcoholic steatohepatitis (NASH) to MASH aims to provide a non-stigmatizing diagnosis [5]

Company Overview - Sagimet is a clinical stage biopharmaceutical company focused on developing programs that inhibit fatty acid synthase (FASN) [2] - FASN is an enzyme that regulates various organs and pathways in the body, and its overexpression is linked to several health issues [2] Key Development Areas - The primary development focus is on MASH (Metabolic Dysfunction-Associated Steatotic Liver Disease), acne, and certain solid tumors in oncology that require FASN for disease progression [2] - Significant work has been conducted in MASH and acne, with preclinical and clinical studies demonstrating the effectiveness of the lead molecule, denifanstat [3]

Company Overview - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [3] - The company is developing fatty acid synthase (FASN) inhibitors, with its lead drug candidate, denifanstat, aimed at treating metabolic dysfunction associated steatohepatitis (MASH) [3] - Denifanstat is an oral, once-daily pill that has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3] Clinical Trials and Developments - The FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH has been successfully completed with positive results [3] - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second oral FASN inhibitor, TVB-3567, which is planned for acne treatment in the U.S. [3] Upcoming Events - Management will participate in the Cantor Global Healthcare Conference in New York on September 3, 2025, with a fireside chat scheduled at 1:35 p.m. ET [4] - The company will also attend the H.C. Wainwright 27th Annual Global Investment Conference in New York on September 9, 2025 [4]

Core Insights - Sagimet Biosciences has made significant progress in developing therapeutics for metabolic dysfunction associated steatohepatitis (MASH) and acne, with denifanstat meeting all primary and secondary endpoints in a Phase 3 clinical trial in China [2][5] - The company has initiated a Phase 1 clinical trial for TVB-3567, a new FASN inhibitor for acne treatment in the U.S., and plans to evaluate a combination of denifanstat and resmetirom in a Phase 1 trial in late 2025 [2][11] Recent Corporate Highlights - Denifanstat's Phase 3 trial in China involved 480 patients and demonstrated a treatment success rate of 33.2% compared to 14.6% for placebo, with significant reductions in total lesion count and inflammatory lesions [5] - The Phase 1 trial for TVB-3567 is designed to assess safety, tolerability, pharmacokinetics, and pharmacodynamics in healthy participants, including those with acne [4][11] Financial Results - As of June 30, 2025, the company reported cash and cash equivalents of $135.5 million, with research and development expenses of $7.2 million for the quarter, up from $6.3 million in the same period in 2024 [11][12] - The net loss for the three months ended June 30, 2025, was $10.4 million, compared to $8.1 million for the same period in 2024 [11][12] Industry Context - Acne affects over 50 million people annually in the U.S., and there has been limited innovation in treatment options over the past 40 years, highlighting the potential market opportunity for new therapies like denifanstat [4][14] - MASH is a progressive liver disease impacting over 115 million people globally, with only one recently approved treatment in the U.S., indicating a significant unmet medical need [13]

Company Overview - Sagimet Biosciences Inc. is a clinical-stage biopharmaceutical company focused on developing novel therapeutics targeting dysfunctional metabolic and fibrotic pathways [3] - The company is developing fatty acid synthase (FASN) inhibitors, with its lead drug candidate, denifanstat, aimed at treating metabolic dysfunction associated with steatohepatitis (MASH) [3] - Denifanstat is an oral, once-daily pill that has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic MASH with moderate to advanced liver fibrosis [3] Clinical Trials and Developments - The FASCINATE-2 Phase 2b clinical trial of denifanstat in MASH has been successfully completed with positive results [3] - Sagimet has initiated a Phase 1 first-in-human clinical trial for a second oral FASN inhibitor, TVB-3567, which is planned for acne treatment in the US [3] Upcoming Events - Management will participate in a fireside chat at the Canaccord Genuity 45 Annual Growth Conference on August 13, 2025, at 2 p.m. EDT in Boston, MA [1] - A webcast of the fireside chat will be available on Sagimet's website, with an archived replay accessible for 90 days post-event [2]

Core Insights - Sagimet Biosciences Inc. is hosting a virtual key opinion leader event on June 16, 2025, to discuss the efficacy and tolerability results of denifanstat for treating moderate to severe acne vulgaris in China [1][2] - Denifanstat is a once-daily oral small molecule fatty acid synthase (FASN) inhibitor that met all primary and secondary endpoints in a Phase 3 clinical trial, demonstrating its potential as a novel treatment for acne, which affects over 50 million people in the U.S. annually [3][7] - The company has initiated a Phase 1 first-in-human study for its second oral FASN inhibitor, TVB-3567, aimed at treating acne in the U.S. [3][6] Company Overview - Sagimet is a clinical-stage biopharmaceutical company focused on developing FASN inhibitors to target metabolic and fibrotic diseases caused by excessive palmitate production [6] - The lead drug candidate, denifanstat, has received Breakthrough Therapy designation from the FDA for treating non-cirrhotic metabolic dysfunction associated steatohepatitis (MASH) with moderate to advanced liver fibrosis [6] - The company successfully completed a Phase 2b clinical trial of denifanstat in MASH, achieving positive results [6] Industry Context - The U.S. acne market includes over 50 million individuals, with 5.1 million patients treated by dermatologists annually [7] - Acne management often requires chronic treatment, as there is currently no cure, and adherence to topical therapies is lower compared to oral medications, with 30% to 40% of patients not adhering to topical treatments [7]