Phase 2 (FASCINATE-1) clinical data in NASH accepted for late-breaker oral presentation; preclinical data accepted for poster presentation
San Mateo, California, March 31, 2020 – Sagimet Biosciences, a clinical-stage biotechnology company, announced today that promising clinical and preclinical research on its lead product candidate, currently being evaluated as a potential treatment for nonalcoholic steatohepatitis (NASH), will be shared at the upcoming European Association for the Study of the Liver (EASL) International Liver Congress™ 2020 (ILC). The conference, originally planned for April of this year, is now scheduled for August 25-28 in London.
Rohit Loomba, M.D., M.H.Sc., Director, NAFLD Research Center, University of California San Diego, and Coordinating Principal Investigator of the study, will share results from an ongoing Phase 2 clinical trial of TVB-2640 in NASH patients in a late-breaker oral presentation entitled “Novel first-in-class, fatty acid synthase inhibitor, TVB-2640 versus placebo demonstrates clinically significant reduction in liver fat by MRI-PDFF in NASH: A phase 2 randomized controlled trial (FASCINATE-1).”
“This is the first clinical data from a FASN inhibitor potentially demonstrating impact on liver fat using an advanced MRI method,” said Dr. Loomba. “We look forward to presenting the results from this promising approach to NASH therapy later this year at this important scientific and medical conference.”
As previously announced, the randomized, controlled trial of TVB-2640 (also known as ASC40 in China) commenced dosing in April 2019 and completed enrollment of the last U.S. cohort in the first quarter of this year. Sagimet expects top-line results from U.S. patients by mid-year 2020. Additional information about the Phase 2 study [NCT03938246] can be found at ClinicalTrials.gov.
Preclinical data from a study testing TVB-2640 in Insphero’s 3D InSight™ Liver Disease Platform, a human liver microtissue model of NASH that reproduces multiple hallmarks of liver tissue damage, will be shared via a poster presentation entitled “The FASN inhibitor TVB-2640 is efficacious in a new 3D human liver microtissue model of NASH.” This disease model can be used to dissect mechanism of action and assess mechanism-based rationale for combinations of NASH agents.
Presentation dates and times will be shared via the EASL ILC conference when the schedule is published.
TVB-2640 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 in the liver of patients with NASH. Sagimet’s approach targets this key driver of NASH. The company announced, along with partner Ascletis Pharma Inc., the initiation of dosing in April 2019 in a randomized, placebo-controlled Phase 2 trial, which will evaluate the impact of TVB-2640 in about 90 NASH patients in the United States and about 25-30 NASH patients in China. The primary endpoint is the impact of TVB-2640 on liver fat reduction by MRI-PDFF following 12 weeks of once-daily, continuous dosing. The trial will also evaluate TVB-2640’s impact on levels of plasma triglycerides, liver enzymes, inflammatory and fibrotic biomarkers. The company has demonstrated in preclinical models that blocking FASN not only reduces liver fat, but directly reduces inflammation and fibrosis – addressing three major drivers of NASH.
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 platform of proprietary FASN inhibitors. For more information, please visit www.sagimet.com.
Juliette Bogus, PressComm PR