Gannex Announces U.S. IND Approval and Initiation of Global Development of THR-? Agonist ASC41 for NASH

SHANGHAI, Feb. 24, 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), today announces the Investigational New Drug Application (IND) approval by U.S. Food and Drug Administration (FDA) and initiation of global development of ASC41 oral tablet, a liver-targeted prodrug. The active metabolite of ASC41 is a selective thyroid hormone receptor beta (THR-?) agonist.

The U.S. IND approval was based on efficacy and safety data from the phase I randomized, double-blind, placebo controlled single- and multiple-ascending dose study in 65 subjects completed in China and commercially ready oral tablet formulation developed with in-house proprietary technology. The U.S. IND approval enables the Company to initiate the clinical trials in the U.S., the biggest NASH market in the world.

In May 2020, the first IND of ASC41 for NASH indication was approved by China's National Medical Products Administration (NMPA). (Details referring to press release: https://www.ascletis.com/news_detail/172/id/370.html)

In January 2021, the Company completed a phase I randomized, double-blind, placebo controlled single- and multiple-ascending dose study in 65 subjects with elevated low-density lipoprotein cholesterol (LDL-C) (> 110 mg/dL), in which subjects demonstrated clinically meaningful and statistically significant reduction in LDL-C and triglycerides compared to placebo after 14 days of once daily oral dosing. At a very low dose of 1 mg, placebo-adjusted relative triglyceride reduction from baseline was 39% (P=0.002).

(Details referring to press release: https://www.ascletis.com/news_detail/175/id/454.html)

In February 2021, the Company announced that overweight and obese subjects demonstrated sustainable, clinically meaningful and statistically significant reduction in LDL-C, triglyceride (TG), total cholesterol (TC), compared to placebo over 28 days of oral dosing of ASC41 tablets. (Details referring to press release: https://www.ascletis.com/news_detail/175/id/46,2.html)

Melissa Palmer, MD, Chief Medical Officer of Gannex said, "ASC41 is now the second NASH program we moved into the global development, as Gannex received IND approval and Fast Track Designation for ASC42, an FXR agonist less than 5 months ago. Gannex has an aggressive pipeline development program for NASH with three different targets, FASN, THR-? and FXR, and is progressing at full speed with two global development programs and one China focused program. "

Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis said, "In addition to the development of three single agents for NASH, the second strategic goal of the Company is to develop three combination therapies for NASH, namely ASC40/ASC42, ASC41/ASC42 and ASC40/ASC41 combo therapies."

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.