SHANGHAI, Dec. 22, 2020 /PRNewswire/ -- 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."
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 viral hepatitis, NASH 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 thirteen R&D pipeline drug candidates or combination therapies (nine of them developed in-house). 1. 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. 2. 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. 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.