Denifanstat/Resmetirom Combination Development Program May 29, 2025 Forward-Looking Statements and Disclaimer This presentation 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 document, other than statements of historical facts or statements that relate to present facts or current conditions, including but not limited to, statements regarding possible or assum ...

SAN MATEO, Calif., June 09, 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 Monday, June 16, 2025 at 2:00 PM ET. To register, click here. The event will feature key opinion leader (KOL) Neal Bhatia, MD (Director of Clinical Dermatology at Therapeutics Clinical Research in San Diego), who wi ...

4 June 2025 | 12:29PM EDT Sagimet Biosciences (SGMT): Ph3 Ascletis-partnered trial confirms denifanstat's therapeutic profile in acne SGMT's partner Ascletis (covered by Ziyi Chen) announced positive topline results from its Ph3 trial of denifanstat in patients with moderate to severe acne. Part of a joint-development program between SGMT/Ascletis, the study evaluated denifanstat's efficacy and safety in 480 patients treated with either denifanstat 50mg (QD, oral) or matching placebo for 12 weeks and found ...

Denifanstat met all primary and secondary endpoints versus placebo Denifanstat was well tolerated Oral FASN inhibitors offer a novel mechanism of action for the potential treatment of moderate to severe acne Sagimet initiated first-in-human Phase 1 clinical trial of a second FASN inhibitor, TVB-3567, that is planned to be developed for acne in the U.S. SAN MATEO, Calif., June 04, 2025 (GLOBE NEWSWIRE) -- Sagimet Biosciences Inc. (Nasdaq: SGMT), a clinical-stage biopharmaceutical company developing novel the ...

Core Insights - Ascletis Pharma Inc. announced that denifanstat (ASC40), a first-in-class oral fatty acid synthase (FASN) inhibitor, successfully met all primary and secondary endpoints in a Phase III clinical trial for moderate to severe acne vulgaris [1][6][10] Clinical Trial Overview - The Phase III trial was a randomized, double-blind, placebo-controlled study conducted in China with 480 patients, comparing 50 mg denifanstat to a placebo over 12 weeks [2] - Baseline characteristics were well balanced between the treatment and placebo groups, with total lesion counts of 102.2 for denifanstat and 102.1 for placebo [11] Efficacy Results - Primary endpoints showed a treatment success rate of 33.2% for denifanstat versus 14.6% for placebo (p<0.0001) [3] - Denifanstat achieved a 57.4% reduction in total lesion count compared to 35.4% for placebo (p<0.0001) and a 63.5% reduction in inflammatory lesions compared to 43.2% for placebo (p<0.0001) [3] - Key secondary endpoint results included a 51.9% reduction in non-inflammatory lesions for denifanstat versus 28.9% for placebo (p<0.0001) [3] Safety Profile - Denifanstat demonstrated a favorable safety and tolerability profile, with treatment-emergent adverse events (TEAEs) comparable to placebo [4] - No TEAEs related to denifanstat exceeded 10%, and all reported adverse events were mild or moderate [4] Mechanism of Action - Denifanstat works by directly inhibiting facial sebum production and inflammation, addressing the underlying causes of acne [5] - This mechanism differentiates denifanstat from other acne treatments that do not target the root cause of the condition [5] Comparative Efficacy - In non-head-to-head comparisons, denifanstat was found to be 98% and 178% more effective than sarecycline and doxycycline, respectively, in terms of placebo-adjusted treatment success [7][8] - Denifanstat was also 60% more effective than clascoterone cream regarding treatment success [7][8] Market Potential - Denifanstat is positioned as a first-in-class oral acne therapeutic with exceptional efficacy and a favorable safety profile, potentially improving patient compliance compared to topical treatments [9] - The company plans to submit denifanstat for approval to the China National Medical Products Administration (NMPA) [6]

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 Ce ...

Core Viewpoint - Sagimet Biosciences Inc. is advancing its clinical-stage biopharmaceutical development, particularly focusing on denifanstat for treating metabolic dysfunction associated steatohepatitis (MASH), with promising results from recent clinical trials and plans for further studies [2][5]. Clinical Development - The Phase 2b FASCINATE-2 trial of denifanstat in MASH patients showed successful results, especially in F3 stage patients [2]. - Denifanstat demonstrated similar pharmacokinetic characteristics and tolerability in a Phase 1 trial for patients with and without hepatic impairment [2]. - A Phase 1 clinical trial to evaluate the combination of denifanstat and resmetirom is anticipated to start in the second half of 2025, with results expected in the first half of 2026 [3][12]. Preclinical Data - Preclinical data presented at EASL 2024 indicated that the combination of a FASN inhibitor (TVB-3664) and resmetirom significantly improved liver disease markers, achieving an 80% improvement in NAS compared to 33% and 25% improvements from monotherapies [3][6]. Financial Results - For the quarter ended March 31, 2025, Sagimet reported a net loss of $18.2 million, compared to a net loss of $6.6 million for the same period in 2024 [8][16]. - Research and development expenses increased to $15.3 million from $5.3 million year-over-year, while general and administrative expenses rose to $4.5 million from $3.5 million [12][16]. - As of March 31, 2025, the company had cash, cash equivalents, and marketable securities totaling $144.6 million [12][17]. Corporate Updates - The company successfully completed end-of-Phase 2 interactions with the FDA in October 2024, paving the way for Phase 3 trials in MASH [5]. - Leadership changes include George Kemble transitioning to non-executive Chair of the Board and the appointment of Beth Seidenberg as Lead Independent Director [5]. Industry Context - MASH is a severe liver disease affecting over 115 million people globally, with limited treatment options available [10]. - The renaming of NAFLD to MASLD and NASH to MASH aims to reduce stigma and improve diagnosis [10].