Gannex Filed US IND for Its NASH Drug ASC42, an FXR Agonist

SHANGHAI, China I September 13, 2020 I Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX:1672) announces today that it has filed investigational new drug application (IND) with US FDA for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42.

ASC42 is an in-house developed Farnesoid X Receptor (FXR) agonist. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation and fibrosis.

Gannex has two additional drug candidates at clinical stage in its NASH pipeline, ASC40 and ASC41. ASC42 is expected to be used alone or in combination with ASC40 or ASC41.

ASC40 is an oral fatty acid synthase (FASN) inhibitor. In the Phase II (FASCINATE-1) randomized, placebo-controlled trial of 99 patients in the USA, clinicians evaluated the safety and efficacy of oral, once-daily dosing of ASC40 (TVB-2640) for 12 weeks. The preliminary data showed that ASC40 (TVB-2640) significantly reduced liver fat, the primary efficacy endpoint of this trial, with a 61% responder rate in the 50 mg group. Participants also showed improvement in markers of liver function and fibrosis. ASC40 (TVB-2640) Phase II (FASCINATE-1) data were presented as a Late Breaker at virtual European Association for the Study of the Liver (EASL) International Liver Congress™ 2020 (ILC) on August 28, 2020.

ASC41 is an oral thyroid hormone receptor beta (THR-beta) agonist which recently received IND approval from China's National Medical Products Administration (NMPA) to conduct clinical trials for NASH indication. Topline data of Phase I safety, PK and preliminary efficacy (LDL-C) in healthy volunteers with LDL-C > 110 mg/dL is expected to be available by the end of 2020.

"We are excited about US IND filing of the in-house developed ASC42 that has the potential to be a best-in-class FXR agonist," said Dr. Handan He, Chief Scientific Officer of Ascletis, "ASC42 IND filing demonstrated again our confidence and capability to develop first-in-class or best-in-class NASH drug candidates through our internal effort."

About NASH

NASH is the progressive form of non-alcoholic fatty liver disease (NAFLD), which is characterized by the accumulation of fat in the liver, inflammation and fibrosis (scarring), and can eventually lead to cirrhosis and liver failure. NASH is a major cause of liver disease worldwide and the leading cause of liver transplants for people under 50 in the US. There are currently no approved treatments for NASH.

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on Hong Kong Stock Exchange (Ascletis, 1672.HK). Ascletis is committed to developing and commercializing innovative drugs 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 eleven R&D pipeline drug candidates (seven of them developed in house). 1. Viral hepatitis: (i) marketed all oral HCV regimen of Asclevir® and Ganovo® combination (RDV/DNV regimen) and ASC18 fixed dose combination (FDC), with bridging study finished, is an upgraded version of RDV/DNV regimen. ASC18FDC will further enhance the competitiveness of Ascletis ' hepatitis C products. (ii) marketed Pegasys® for HBV clinical cure; (iii) breakthrough therapies for HBV clinical cure. 2. NASH: global development of novel drug candidates against three different targets – FASN, THR-beta and FXR, which are expected to be used alone or in combination. NASH is a global disease, Ascletis conducts global clinical research in Europe, America and China. 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: Gannex Pharmaceutical

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