Ascletis’ Strategic Partner Sagimet Biosciences, a clinical-stage biotechnology company, announced recently that new results from its Phase 2 FASCINATE-1 trial of TVB-2640(ASC40) in nonalcoholic steatohepatitis (NASH) will be shared in an oral presentation at The Liver Meeting Digital Experience™ 2020 of the American Association for the Study of Liver Diseases (AASLD) to be held November 13 - 16. In this randomized, placebo-controlled trial, a novel, first-in-class, FASN inhibitor, TVB-2640 significantly decreased liver fat and serum biomarkers of liver injury, fibrosis and inflammation with an excellent safety profile and tolerability.

Rohit Loomba, M.D., M.H.Sc., Director, NAFLD Research Center, University of California San Diego, and Coordinating Principal Investigator of the study, will present the results in an oral presentation entitled “Novel, first-in-class, fatty acid synthase (FASN) inhibitor, TVB-2640 demonstrates clinically significant reduction in liver fat by MRI-PDFF, and ALT in NASH: a Phase 2 randomized placebo-controlled trial (FASCINATE-1).”

“The potent liver fat reduction, measured by an advanced MRI method called MRI-PDFF, combined with the additional biomarkers demonstrates that TVB-2640 is positively impacting multiple pathological mechanisms causing liver damage in NASH patients,” said Dr. Loomba. “MRI-PDFF response is an accurate and reliable biomarker that correlates with histological response in NASH and also has been shown to predict NASH resolution. The treatment response seen in TVB-2640 treated subjects in this study along with the additional biomarkers increases our confidence to embark upon a larger Phase 2b liver biopsy based clinical trial in NASH patients with stage 2-3 fibrosis.”

Additional information about the Phase 2 study [NCT03938246] can be found at ClinicalTrials.gov.

Presentation details are as follows:

Abstract Title: Novel, first-in-class, fatty acid synthase (FASN) inhibitor, TVB-2640 demonstrates clinically significant reduction in liver fat by MRI-PDFF, and ALT in NASH: a phase 2 randomized placebo-controlled trial (FASCINATE-1)

Abstract number: 67

Presenting Author: Dr. Rohit Loomba

Session Title: Parallel 9: NAFLD and NASH: Therapeutics

Session Broadcast Date and Time: Sunday, November 15, 2020, 10:30 AM ET

About TVB-2640(ASC40)

TVB-2640(ASC40) is an orally bioavailable, 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. Sagimet’s approach targets these key drivers of NASH. The company 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 NASH patients in the United States. The company, along with partner Ascletis Pharma Inc., is currently enrolling an additional 25-30 NASH patients in China. Based upon the strength of this Phase 2 imaging and biomarker data, Sagimet expects to initiate a Phase 2b biopsy trial in 1H 2021. The company 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

Sagimet Biosciences is a clinical-stage biopharmaceutical company focused on developing novel therapeutics to treat important diseases such as the liver disease NASH and specific cancers, with focus on targeting dysfunctional metabolic pathways. The company has unique expertise in FASN biology and has created a pipeline of proprietary FASN inhibitors. For more information, please visit www.sagimet.com.

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs of viral hepatitis, NASH 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 eleven R&D pipeline drug candidates (seven of them developed in house). 1. Viral hepatitis: (i) marketed all oral HCV regimen of Asclevir® and Ganovo® combination (RDV/DNV regimen) and ASC18 fixed dose combination (FDC), with bridging study finished, is an upgraded version of RDV/DNV regimen. ASC18FDC will further enhance the competitiveness of Ascletis ' hepatitis C products. (ii) marketed Pegasys® for HBV clinical cure; (iii) breakthrough therapies for HBV clinical cure. 2. NASH: global development of novel drug candidates against three different targets – FASN, THR-beta and FXR, which are expected to be used alone or in combination. NASH is a global disease, Ascletis conducts global clinical research in Europe, America and China. 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.