ASC40 (TVB-2640) Phase 2 NASH Trial Completed Patient Enrollment In China
SHANGHAI and SAN FRANCISCO, Nov. 18, 2020 /PRNewswire/ -- Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) and Sagimet Biosciences Inc. jointly announced today that they have completed patient enrollment in the ASC40 (TVB-2640) Phase 2 NASH trial in China. The trial in China with 30 patients enrolled is part of the global Phase 2 clinical program.
On June 17, Sagimet Biosciences Inc., announced positive results on oral, once-daily dosing of NASH drug candidate ASC40 (TVB-2640) from its Phase 2 (FASCINATE-1) clinical trial in the United States. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis. In this randomized, placebo-controlled trial of 99 patients in the United States, clinicians evaluated the safety and efficacy of ASC40 (TVB-2640) for 12 weeks. ASC40 (TVB-2640) was well-tolerated with a benign adverse event profile, predominantly grade 1 adverse events and no on-treatment serious adverse events.
"This is the first Phase 2 NASH trial that has completed patient enrollment in mainland China, which enables the completion of 12 week treatment of all patients in February 2021," said Dr. Junping Shi, Deputy Dean of the Affiliated Hospital of Hangzhou Normal University, Deputy Leader of the Fatty Liver and Alcoholic Hepatology Group of the Chinese Medical Association Hepatology Branch, principal investigator of ASC40 (TVB-2640) Phase 2 trial in China. "We are excited by results from the Phase 2 NASH trial in the United States. Based upon the data from the bridging study in China, I believe the efficacy of ASC40 (TVB-2640) in Chinese patients will be similarly potent."
"Additional data from U.S. patients were recently presented by Dr. Rohit Loomba at The Liver Meeting of American Association for the Study of Liver Diseases (AASLD) that confirm the potential benefit of TVB-2640 to NASH patients. We are excited to move forward with our planned Phase 2b biopsy trial, as well as work with our partner Gannex to understand better dosing of TVB-2640 in Chinese patients," said George Kemble, CEO of Sagimet.
"We are pleased that we completed the patient enrollment ahead of the schedule and want to thank all patients and doctors. I look forward to the completion of this Phase 2 NASH trial in China," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.