In a recent Phase 2a trial, TVB-2640 improved serum biomarkers of liver injury in patients with nonalcoholic steatohepatitis (NASH)
Sagimet Biosciences Inc., a clinical-stage biotechnology company focused on developing a portfolio of internally-discovered, selective fatty acid synthase (FASN) inhibitors, announced recently that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to TVB-2640 for the treatment of patients with NASH.
TVB-2640, is a wholly-owned, oral, selective inhibitor of FASN, a key enzyme involved in the production of saturated fatty acids in the liver and other organs, and is the only enzyme in the human body capable of converting metabolized sugars into palmitate. In patients with NASH, increased FASN-mediated palmitate synthesis in the liver is the source of three key drivers of the disease: excess accumulation of liver fat, inflammation and fibrosis.
In a recent Phase 2 randomized placebo-controlled trial (FASCINATE-1), TVB-2640 demonstrated statistically significant improvement across steatosis, inflammation/lipotoxicity, fibrosis and metabolic biomarkers important in NASH. NASH is currently the leading cause of liver transplantation in women and second only to alcoholic liver disease in men and is expected to become the leading indication for liver transplantation in the United States.
George Kemble, Ph.D., Sagimet’s chief executive officer, said, “The FDA’s Fast Track designation for TVB-2640 demonstrates recognition of TVB-2640’s potential to address unmet needs of NASH patients. There are currently no FDA-approved therapies on the market to treat NASH. This designation brings us one step closer to a potential treatment for patients with this critical unmet need.”
Fast Track designation is designed to facilitate drug development and expedite the review of drugs that are developed to treat serious conditions and fill an unmet medical need. The FDA defines filling an unmet medical need as providing a therapy where none exists or providing one that may offer advantages over currently available therapy. A company whose drug receives Fast Track designation may be eligible for more frequent meetings and written communications with FDA to discuss the drug’s development plan and ensure collection of appropriate data needed to support drug approval; eligibility for Accelerated Approval and Priority Review, if relevant criteria are met; and eligibility for rolling review of a New Drug Application (NDA), where the FDA may consider for review sections of the NDA on a rolling basis before the complete application is submitted.
ASC40 (known as TVB-2640 outside of China) is an orally bioavailable, potentially first-in-class FASN inhibitor. FASN is a key enzyme in the de novo lipogenesis (DNL) pathway that is responsible for the synthesis of excess fat and activation of fibrogenic and inflammatory mechanisms in the liver of patients with NASH. ASC40 targets these key drivers of NASH. Sagimet announced in June 2020 initial results of a randomized, placebo-controlled Phase 2 trial, FASCINATE-1, which evaluated the impact of TVB-2640 in 99 patients with NASH in the United States. Sagimet has demonstrated in preclinical models that blocking FASN not only reduces liver fat, but directly reduces fibrosis and inflammation – addressing three major drivers of NASH.
About Sagimet Biosciences
Sagimet is a clinical-stage biopharmaceutical company focused on developing a portfolio of internally-discovered, selective fatty acid synthase (FASN) inhibitors for the treatment of several diseases that result from the overproduction of the fatty acid palmitate. Based on its clinical and preclinical data, Sagimet believes that its wholly-owned pipeline of oral FASN inhibitors has the potential to offer effective treatments for indications in several therapeutic areas of high unmet medical need including liver diseases and cancers. TVB-2640, an oral, once-daily pill, is Sagimet’s lead drug candidate that was selected from more than 1,200 compounds in its library of FASN inhibitors and has been studied in over 260 subjects, including healthy volunteers and patients with non-alcoholic steatohepatitis (NASH) or cancer. For more information, please visit www.sagimet.com.
Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, viral hepatitis and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.
Ascletis has three marketed products and twelve R&D pipeline drug candidates or combination therapies (nine of them developed in-house). 1. NASH: Gannex, a wholly-owned company of Ascletis, is fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THR-beta and FXR, and three pre-clinical stage combination therapies. 2. Viral hepatitis: (i) Hepatitis B: focus on breakthrough therapies for HBV clinical cure with subcutaneously injected PD-L1 antibody - ASC22 and Pegasys® as cornerstone drugs. (ii) Hepatitis C: successfully launched all oral regimen of ASCLEVIR® and GANOVO® combination (RDV/DNV regimen); and ASC18 fixed dose combination (FDC) is an upgraded version of RDV/DNV regimen with bridging study finished. 3. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved. For more information, please visit www.ascletis.com.