Ascletis Pharma Completes Bridging Study In China For NASH Drug Candidate ASC40

(RTTNews) - Ascletis Pharma Inc. said that a single-dose, pharmacokinetic bridging study of non-alcoholic steatohepatitis or NASH drug candidate ASC40 in 34 Chinese subjects has been completed and data indicates that key pharmacokinetic parameters are consistent between subjects in China and in the United States.

The 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 announced positive results on oral, once-daily NASH drug candidate ASC40 from its Phase 2 clinical trial. The preliminary data showed that ASC40 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 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 was well-tolerated with a benign adverse event profile, predominantly grade 1 events and no on-treatment serious adverse events.

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