Gannex Announces Positive Clinical Results in Overweight and Obese Subjects for Its THR-β Agonist ASC41

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

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Feb 21, 2021, 06:30 ET

SHANGHAI, Feb. 21, 2021 /PRNewswire/ -- 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.

Placebo-adjusted relative change (mean) from baseline after 14 or 28 days of once
daily oral dosing of 10 mg ASC41 tablets in overweight and obese subjects

14-day dosing

(n=13)

28-day dosing

(n=13)

Placebo-adjusted LDL-C reduction

P value vs placebo

-38.85%

P=0.001

-37.30%

P=0.002

Placebo-adjusted HDL-C reduction

P value vs placebo

-4.85%

P=0.452

-2.86%

P=0.651

Placebo-adjusted triglyceride
reduction

P value vs placebo

-43.68%

P=0.032

-40.96%

P=0.005

Placebo-adjusted total cholesterol
reduction

P value vs placebo

-28.57%

P=0.003

-27.10%

P=0.003

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."

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, viral hepatitis and HIV/AIDS for unmet medical needs in China and globally. Led by a management team with deep expertise and a proven track record, Ascletis has developed into a fully integrated platform covering the entire value chain from discovery and development to manufacturing and commercialization.

Ascletis has three marketed products and twelve R&D pipeline drug candidates or combination therapies (nine of them developed in-house). 1. NASH: Gannex, a wholly-owned company of Ascletis, is fully dedicated to the R&D and commercialization of new drugs in the field of NASH. Gannex has three clinical stage drug candidates against three different targets – FASN, THR-beta and FXR, and three pre-clinical stage combination therapies. 2. Viral hepatitis: (i) Hepatitis B: focus on breakthrough therapies for HBV clinical cure with subcutaneously injected PD-L1 antibody - ASC22 and Pegasys® as cornerstone drugs. (ii) Hepatitis C: successfully launched all oral regimen of ASCLEVIR® and GANOVO® combination (RDV/DNV regimen); and ASC18 fixed dose combination (FDC) is an upgraded version of RDV/DNV regimen with bridging study finished. 3. HIV/AIDS: ASC09F is a FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved. For more information, please visit www.ascletis.com.

SOURCE Ascletis Pharma Inc.