FASN

Shenzhen Chipscreen Biosciences Co. is the latest company to report positive data for a metabolic dysfunction-associated steatohepatitis (MASH) drug candidate. On Monday, the Chinese biotech said its PPAR pan-agonist chiglitazar cleared a key hurdle, meeting the primary efficacy endpoint of a Phase II study.The trial win comes on the heels of the FDA's approval last week of Madrigal Pharmaceuticals' THR-β selective agonist Rezdiffra (resmetirom), the first drug waved through by US regulators to treat the liver disease. Cleared via the FDA's accelerated pathway, Rezdiffra is indicated for adult patients with non-cirrhotic MASH and moderate-to-advanced liver fibrosis consistent with stages F2 to F3 fibrosis. The drug hits the market next month at a US list price of $47,400 per year.Chiglitazar, also known as carfloglitazar, has been approved in China since 2021 under the brand name Bilessglu to treat type 2 diabetes.The current trial, dubbed CGZ203, tested two doses of chiglitazar monotherapy or placebo given once daily for 18 weeks to patients diagnosed with MASH. Chipscreen said the primary endpoint was met at both dose levels, producing "significant and dose-dependent reductions" in liver fat content compared to placebo after 18 weeks, based on MRI-proton density fat fraction (MRI-PDFF).Both dose groups also showed "significant or dose-dependent trend of improvements" on secondary measures such as the proportion of patients achieving a >30% decrease in liver fat content, non-invasive indicators related to hepatocyte damage, inflammation, and fibrosis, the company said. Chipscreen said "overall safety is good," and that further data analyses are underway.Other MASH drug hopefuls with recent positive readouts include Akero Therapeutics' efruxifermin, engineered to mimic the FGF21 hepatic hormone; Ionis Pharmaceuticals' antisense inhibitor ION224; Sagimet Biosciences' FASN inhibitor denifanstat; the dual GLP-1 and glucagon agonist survodutide being co-developed by Boehringer Ingelheim and Zealand Pharma; as well as Viking Therapeutics' VK2809, which like Rezdiffra also targets thyroid hormone receptor beta.

HANGZHOU and SHAOXING, China, March 10, 2024 /PRNewswire/ -- Ascletis Pharma Inc. (HKEX: 1672, "Ascletis") today announces the poster presentation of Phase II study final results of ASC40, a first-in-class fatty acid synthase (FASN) inhibitor for treatment of acne, at the 2024 American Academy of Dermatology (AAD) Annual Meeting in San Diego, the United States. The summary of the poster is shown as below: Title: First FASN inhibitor ASC40 to treat acne vulgaris patients: final results from a Phase 2 trial Method: This phase 2 trial (NCT05104125) was a randomized, double-blind, placebo-controlled, multicenter study. 180 patients were 1:1:1:1 assigned to the ASC40 25\50\75 mg or placebo QD for 12-week treatment and 2-week follow-up. Efficacy and safety of ASC40 vs placebo were assessed. Background: ASC40 (denifanstat) is a potent and selective small molecule inhibitor of fatty acid synthase (FASN). Mechanisms of action of ASC40 for acne treatment are novel: (1) direct inhibition of facial sebum production through inhibition of de novo lipogenesis (DNL) in sebocytes; and (2) inhibition of inflammation through decreasing cytokine secretion. Previous clinical studies showed that ASC40 treatment for 10 days reduced significantly facial sebum palmitic acid levels. Here we report the efficacy and safety results from a phase 2 study of ASC40 in patients with moderate to severe acne vulgaris after 12-week treatment. Results: At week 2, 4, 8 and 12, percentage and absolute change from baseline in total lesion, inflammatory and non-inflammatory lesion counts as well as treatment success and Investigator's Global Assessment (IGA) reduction ≥ 2 were assessed. At all doses, above efficacy measures generally improved from week 2 to week 12. 50 mg QD demonstrated the best efficacy: placebo-adjusted proportion of patients with treatment success and IGA reduction ≥ 2 were 14.3% and 16.2%, respectively. Placebo-adjusted median percentage (absolute) change from baseline in total lesion and inflammatory counts were -27.1% (-23.5) and -33.5% (-13), respectively (p = 0.008 (0.030) and 0.003 (0.003)). Safety: The incidence rates of study drug related AEs were comparable among 25 mg (grade 1 = 28.9%; grade 2 = 20.0%), 50mg (grade 1 = 36.4%; grade 2 = 11.4%), 75 mg (grade 1 = 44.4%; grade 2 = 17.8%) ASC40 and placebo (grade 1 = 35.6%; grade 2 = 13.3%). The most common study drug related AE was dry eyes whose incidence rates were similar among 25 mg (grade 1 =17.8%; grade 2 = 6.6%), 50 mg (grade 1 = 22.7%; grade 2 = 2.3%), 75 mg (grade 1 = 15.5%; grade 2 =11.1%) ASC40 and placebo (grade 1 = 28.9%; grade 2 = 6.6%). There were no clinically significant findings in clinical laboratory, vital signs and electrocardiography. There were no ASC40 related grade 3 or 4 AEs and no ASC40 related serious AEs (SAEs). Conclusion: Based on efficacy and safety data from this phase 2 trial, a phase 3 clinical trial of 50 mg QD ASC40 with 12-week treatment has been initiated. "It's a great honor to present our Phase II clinical trial results of ASC40 for acne treatment at the AAD Annual Meeting. The FASN inhibitor ASC40 is a first-in-class drug candidate with novel mechanism, demonstrating significant efficacy and good safety in the Phase II clinical trial. Currently, the enrollment of Phase III clinical trial of ASC40 for acne is accelerating. We expect to bring more benefits for acne patients in the future." said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis. Ascletis holds the rights to develop, manufacture and commercialize ASC40 in Greater China under an exclusive license from Sagimet Biosciences Inc. About AAD Founded in 1938, the annual meeting of the American Academy of Dermatology (AAD) is the largest, most influential, and most representative dermatological society in the United States. The 2024 AAD Annual Meeting is held at the San Diego Convention Center in San Diego, the United States, from March 8 to March 12, 2024. About Ascletis Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and oncology. Through excellent execution, Ascletis rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has multiple drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors). For more information, please visit . SOURCE Ascletis Pharma Inc.

SAN MATEO, Calif., Feb. 29, 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 management will participate in two upcoming investor conferences. A fireside chat at the TD Cowen 44th Annual Health Care Conference in Boston at 2:10 p.m. ET / 11:10 a.m. PT on March 5, 2024; andA podium presentation at the Leerink Partners Global Biopharma Conference 2024 in Miami at 8:00 a.m. ET / 5:00 a.m. PT on March 13, 2024. Webcasts of each presentation will be available in the Investors & Media section of Sagimet’s website at www.sagimet.com, with archived replays available for 90 days following the live event. 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 NASH, for which there are no treatments currently approved in the United States or Europe. FASCINATE-2, a Phase 2b clinical trial of denifanstat in NASH with liver biopsy-based primary endpoints, was successfully completed with positive results. Contact: Maria YonkoskiICR Westwicke203-682-7167maria.yonkoski@westwicke.com