Biotechnology company Ascletis Pharma Inc (1672.HK) said on Tuesday that its subsidiary has announced the IND approval from National Medical Products Administration (NMPA) for its non-alcoholic steatohepatitis (NASH) drug candidate ASC40 ( TVB-2640).

According to the company, ASC40 (TVB-2640), which is an orally bioavailable, first-in-class inhibitor of fatty acid synthase (FASN), is currently in a global Phase 2 trial in NASH, of which the first patient was dosed in late April, 2019 in the USA.

Under the company's randomised, placebo-controlled global Phase 2 trial, the investigators are evaluating the impact of ASC40 (TVB-2640) in about 90 NASH patients in the United States and about 25-30 NASH patients in China. The investigators will evaluate ASC40 (TVB-2640)'s impact on levels of plasma triglycerides, liver enzymes, inflammatory and fibrotic biomarkers.

In the study, the 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 of the study is the impact of ASC40 (TVB-2640) on liver fat reduction, compared to baseline, following 12 weeks of daily, continuous dosing, concluded the company.