• First-in-class fatty acid synthase (FASN) inhibitor
• Combination opportunities with ASC42 (FXR) and ASC41 (THR-β)
• In two NASH animal models, FASN inhibition reduced liver fat (steatosis), liver inflammation and fibrosis, and in one of these models even reduced the number of liver tumors observed
• In June 2020, Sagimet announced preliminary data from the U.S. Phase II trial, which showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint, with a 61% responder rate in the 50 mg group
• In November 2020, the first ever Phase II NASH trial in China completed patient enrollment
• In March 2021, ASC40 demonstrated positive Phase II topline clinical results from China cohort of patients with NASH
• In March 2021, U.S. Food and Drug Administration (FDA) granted Fast Track designation to ASC40 (TVB-2640) for NASH indication
• A liver-targeted prodrug. The active metabolite of ASC41 is a selective thyroid hormone receptor beta (THR-β) agonist
• Proprietary, oral tablet formulation, stable at room temperature
• Combination opportunities with ASC42 (FXR) and ASC40 (FASN)
• In two NASH animal models, ASC41 demonstrated the same improvement in liver steatosis, inflammation and fibrosis
• In January 2021, topline data of Phase I safety, PK and preliminary efficacy (LDL-C) in healthy volunteers with LDL-C > 110 mg/dL suggest that after 14 days of once daily oral dosing, subjects demonstrate clinically meaningful and statistically significant reductions in LDL-C and triglycerides compared to placebo. In addition, ASC 41 was well tolerated and had a benign adverse event profile
• In February 2021, the Investigational New Drug (IND) Application of ASC41 approved by the U.S. FDA
• In April 2021, the first cohort dosed in the U.S. Phase I clinical study of drug interaction and non-alcoholic fatty liver disease (NAFLD) patient pharmacokinetics for ASC41
• A novel, non-steroidal, selective, potent FXR agonist with best-in-class potential
• Proprietary, oral tablet formulation, developed in-house, stable at room temperature
• Combination opportunities with ASC41 (THR-β) and ASC40 (FASN)
• In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation, and fibrosis
• In October 2020, the IND application of ASC42 approved by the U.S. FDA
• In December 2020, U.S. FDA granted Fast Track designation to ASC42 for NASH indication
• In May 2021, the IND application of ASC42 approved by the China National Medical Products Administration (NMPA)
• In June 2021, topline results of the U.S. Phase I trial in 64 healthy subjects demonstrate ASC42 was safe and tolerated
