Overweight and Obese Subjects Dosed with ASC41 Tablets in a Phase Ib Trial

Shanghai, China, 22 December 2020 -- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672) and fully dedicated to the R&D and commercialization of new drugs in the field of NASH, announces today dosing of overweight and obese subjects in a Phase Ib trial of ASC41, an oral tablet, liver-targeted prodrug and its active moiety (ASC41-A), a selective thyroid hormone receptor beta (THR-β) agonist.

This phase Ib trial is a randomized, double-blind, placebo controlled study in overweight and obese subjects with elevated low-density lipoprotein cholesterol (LDL-C) (> 110 mg/dL). The treatment duration is 28 days with 10 mg oral ASC41, once daily. The objectives of this trial are to evaluate 1) the impact of ASC41 on markers of cardiac health, i.e., LDL-C, triglyceride (TG), total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C); 2) the safety and tolerability of ASC41 tablets; 3) the pharmacokinetics of ASC41 tablets and its active moiety, ASC41-A, in overweight and obese subjects.

“We are excited about dosing ASC41 in overweight and obese subjects with elevated LDL-C, as this population is characteristic of nonalcoholic fatty liver disease (NAFLD),” said Melissa Palmer, MD, Chief Medical Officer of Gannex, “The data from this study will offer important safety and preliminary efficacy readouts that will enable us to advance this clinical program into patients with nonalcoholic steatohepatitis (NASH).”

“This phase Ib trial is the second clinical study for ASC41 tablets after the first single and multiple ascending dose clinical study,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, “With the recent Fast Track Designation by US FDA for ASC42, a potential best-in-class FXR agonist, we are moving forward at full speed for our global leading NASH pipeline against three different targets, namely FASN, THR-β and FXR.”