Bridging Study in China Completed for NASH Drug Candidate ASC40

July 20,2020

Ascletis Pharma Inc. (HKEX code: 1672) announces today that a single-dose, pharmacokinetic bridging study of non-alcoholic steatohepatitis (NASH) drug candidate ASC40 (TVB-2640) in 34 Chinese subjects has been completed and data indicates that key pharmacokinetic parameters (C_max, AUC, T_max and t_1/2) are consistent between subjects in China and in the United States.

This bridging study in China demonstrated linear pharmacokinetic for ASC40 (TVB-2640) from oral, single doses of 25, 50 to 75 mg. ASC40 is safe and well-tolerated in Chinese subjects and majority of adverse events are grade 1.

On June 17, Ascletis' partner Sagimet Biosciences Inc., announced positive results on oral, once-daily NASH drug candidate ASC40 (TVB-2640) from its Phase 2 (FASCINATE-1) clinical trial. 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 the Phase 2 (FASCINATE-1) 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 events and no on-treatment serious adverse events.

"Since the 50 mg cohort of 25-30 Chinese NASH patients in the FASCINATE-1 trial has started, the data from this bridging study makes us more confident of the efficacy and safety in Chinese NASH patients," said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

Ascletis has two additional drug candidates, developed in house, in its NASH pipeline. With 3 candidates at various development stages, Ascletis' NASH pipeline is competitive on the global scale and these three NASH candidates can be used alone or in combination.