-     Data Further Confirmed Doses for Phase II Trial in Patients with NASH

Shanghai, China, 21 February 2021-- Gannex, a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), fully dedicated to the R&D and commercialization of new drugs in the field of nonalcoholic steatohepatitis (NASH), announces the positive clinical results in overweight and obese subjects for ASC41, a liver-targeted prodrug. The active metabolite of ASC41 is a selective thyroid hormone receptor beta (THR-β) agonist.

Twenty overweight and obese subjects with elevated low density lipoprotein cholesterol (LDL-C) (> 110 mg/dL) were treated with ASC41 10 mg oral tablets or matching placebo tablets once daily in this randomized, double-blind, placebo controlled clinical study. Preliminary data suggested that over 28 days of oral dosing of ASC41, subjects demonstrated sustainable, clinically meaningful and statistically significant reduction in LDL-C, triglyceride (TG), total cholesterol (TC), compared to placebo. High-density lipoprotein cholesterol (HDL-C) remained relatively unchanged.

ASC41 had a relatively benign adverse event profile in this study. The majority of adverse events (AEs) were grade 1 or 2, with only 3 grade 3 AEs (2 in the ASC41 group and 1 in the placebo group). There were no serious adverse events (SAEs).

“We are excited about the completion of this clinical study 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 offered important safety and preliminary efficacy readouts that enable us to advance this clinical program into patients with NASH.”

“With the positive clinical results in overweight and obese subjects for ASC41 and the Company’s participation in recent Sagimet’s US$80 million crossover financing with global premium investors,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, “we are moving forward at full speed for our global leading NASH pipeline with three different targets, FASN, THR-β and FXR.”