Sagimet Biosciences' partner Ascletis reported strong phase 3 results for denifanstat in moderate-to-severe acne, validating FASN inhibition as a novel oral treatment. Sagimet is advancing next-gen FASN inhibitor TVB-3567 for U.S. acne trials and planning a phase 1b combo study with denifanstat and resmetirom for MASH. The acne market is large and underserved, while FASN inhibition offers potential in both dermatology and metabolic disease, expanding SGMT's addressable market.
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 therapeutics targeting dysfunctional metabolic and fibrotic pathways, today reported denifanstat met all primary and secondary endpoints in a Phase 3 clinical trial for the treatment of moderate to severe acne vulgaris conducted by Sagimet's license partner Ascletis Bioscience Co. Ltd.
Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026 Phase 1 clinical trial to evaluate the pharmacokinetics (PK) of a combination of denifanstat and resmetirom expected to initiate in 2H 2025; data readout expected 1H 2026
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Biotechnology Industry | Healthcare Sector | Mr. David A. Happel CEO | XSTU Exchange | US7867001049 ISIN |
US Country | 14 Employees | - Last Dividend | - Last Split | 14 Jul 2023 IPO Date |
Sagimet Biosciences Inc., originally founded as 3-V Biosciences, Inc., underwent a rebranding in August 2019 to better reflect its focused mission in the biomedical field. This clinical-stage biopharmaceutical company is at the forefront of developing innovative treatments targeting diseases caused by dysfunctional lipid metabolism pathways. With its incorporation in 2006, Sagimet Biosciences has dedicated its efforts to exploring the potential of fatty acid synthase (FASN) inhibitors. These compounds have shown promise in addressing a variety of conditions linked to lipid metabolism, underlying the company's commitment to advancing healthcare solutions from its headquarters in San Mateo, California. Its research and development pivot around Denifanstat and TVB-3567, reflecting a broader strategy to combat prevalent health issues like nonalcoholic steatohepatitis (NASH) and specific cancer types, along with other conditions such as acne that denote significant unmet medical needs.
As the flagship product of Sagimet Biosciences, Denifanstat signifies a breakthrough in the treatment of nonalcoholic steatohepatitis (NASH), a serious liver condition lacking effective FDA-approved treatments. This innovative therapy, derived from the company’s proprietary research into fatty acid synthase (FASN) inhibitors, showcases Sagimet’s commitment to addressing diseases with significant unmet needs. In addition to NASH, Denifanstat has the potential to offer a novel treatment solution for acne, further demonstrating the broad therapeutic applications of FASN inhibitors in managing conditions linked to lipid metabolism dysfunctions.
TVB-3567 stands as Sagimet Biosciences’ pivotal entry into cancer therapy, embodying the company's innovative approach towards leveraging FASN inhibitors against various cancer types. This development aligns with the growing recognition of metabolic pathways, such as those governed by fatty acid synthase, as critical points of intervention in cancer treatment. Sagimet’s pursuit of TVB-3567 underscores a strategic focus on expanding the utility of its FASN inhibitor platform to tackle the complexities of cancer, aiming to provide patients with new, effective therapeutic options.