San Mateo, California, United States, and Hangzhou and Shaoxing, China, 30 April 2019 – 3-V Biosciences, Inc. (3-V Biosciences) and Ascletis Pharma Inc. (Ascletis, 1672.HK) announced today that 3-V Biosciences has recently dosed its first patient in a Phase 2 clinical trial of the FASN (fatty acid synthase) inhibitor TVB-2640 (Ascletis code: ASC40) in patients with non-alcoholic steatohepatitis (NASH).
According to Rohit Loomba, MD, University of California San Diego, Director, NAFLD Research Center, and Coordinating Investigator of the now enrolling Phase 2 study of TVB-2640, “Lipid synthesis is an important driver of NASH. The imaging techniques in this study will give us a very clear understanding of the impact this drug has on liver fat, a key driver of this disease.”
In this randomized, placebo-controlled study, investigators will evaluate the impact of TVB-2640 in about 90 NASH patients in the United States and about 25-30 NASH patients in China. Study participants will have at least 8% liver fat at baseline, as measured by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF), and evidence of stage F1 to F3 fibrosis. The primary endpoint is the impact of TVB-2640 on liver fat reduction, compared to baseline, following 12 weeks of daily, continuous dosing. Investigators will also evaluate TVB-2640’s impact on levels of plasma triglycerides, liver enzymes, inflammatory and fibrotic biomarkers.
In February 2019, 3-V Biosciences and Ascletis entered into an exclusive license agreement, under which 3-V Biosciences granted Ascletis an exclusive license to develop, manufacture and commercialize TVB-2640 (Ascletis code: ASC40) and related compounds in Greater China. In connection with this Phase 2 trial, Ascletis is working with 3-V Biosciences in China on regulatory submissions, clinical site selection, and trial monitoring.
“The initiation of our Phase 2 clinical trial is a very important advance for TVB-2640 and for 3-V Biosciences. We are very encouraged by the data from the Phase 1 studies and this next step is critical in determining the impact TVB-2640 may have in the treatment of NASH patients,” said William McCulloch, MB, ChB, FRCP, FFPM, Chief Medical Officer of 3-V Biosciences.
“We are excited about the first patient dosed in this Phase 2 trial and working with 3-V Biosciences in China to move this first-in-class drug candidate forward,” said Jinzi J. Wu, PhD, Founder, Chairman and CEO of Ascletis.
About TVB-2640 (ASC40)
TVB-2640 is an orally bioavailable, first-in-class inhibitor of FASN. 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. 3-V’s approach targets this key driver of NASH. The company demonstrated in a Phase 1 trial that TVB-2640 inhibited liver fat synthesis in subjects with characteristics of metabolic syndrome. The 3-V team believes these data provide clinical proof-of-mechanism for TVB-2640. Dysregulation of FASN activity is also found in several other diseases, including certain cancers where cells become dependent upon DNL.
About 3-V Biosciences
3V-Biosciences is a clinical-stage biopharmaceutical company focused on developing novel therapeutics for the treatment of a range of diseases including the liver disease NASH and certain cancers, with focus on targeting dysfunctional metabolic pathways. 3-V Biosciences has unique expertise in FASN biology and believes that targeting FASN provides an intervention point for clinical benefit. For more information, please visit www.3vbio.com.
Ascletis is an innovative R&D driven biotech with two commercial products and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis’ mission is to address unmet medical needs in three therapeutic areas: viral, cancer and fatty liver diseases. Led by a management team with deep expertise and a proven track record, Ascletis has developed a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization. Ascletis is now commercializing two drugs, Ganovo® (danoprevir), the first direct-acting anti-viral agent for hepatitis C developed domestically for China, and Pegasys® (peginterferon alfa-2a), a well-established pegylated interferon for hepatitis B&C partnered with Roche. Ascletis’ R&D pipeline consists of antibody-based immunotherapy, first/best-in-class small molecules and siRNA at various clinical development stages. For more information, please visit www.ascletis.com.
3-V Biosciences, Inc.
Juliette Bogus, PressComm PR
Ascletis Pharma Inc.
Chenlin Li, +86-159-6815-8530