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 announced today that it received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its non-alcoholic steatohepatitis (NASH) drug candidate ASC42.

The U.S. FDA's Fast Track development program is designed to facilitate the development and expedite the review of drugs that have the ability to treat serious or life-threatening diseases or conditions and demonstrate the potential to address unmet medical needs with additional clinical benefits to patients. There are no FDA approved medicines for NASH indication yet. This Fast Track designation represents the FDA's recognition of ASC42's potential in addressing these unmet medical needs for NASH patients.

Gannex received the investigational new drug application (IND) approval for ASC42 from the U.S. FDA in October this year. ASC42 is an in-house developed，novel non-steroidal, selective, potent Farnesoid X Receptor (FXR) agonist with best-in-class potential. In two NASH animal models, ASC42 demonstrated significant improvements in liver steatosis, inflammation, and fibrosis. The oral tablet formulation of ASC42 has been developed with in-house proprietary technology and is stable at room temperature.

"We are thrilled that the FDA granted Fast Track designation for our FXR agonist ASC42 which is discovered and developed by our in-house talented R&D team," said Dr. Jinzi J. Wu, "This critical recognition by FDA will accelerate global development of ASC42, a potential best-in-class FXR agonist."

Gannex has two additional drug candidates at a clinical-stage in its NASH pipeline, ASC40, and ASC41. ASC40(TVB-2640), an oral fatty acid synthase (FASN) inhibitor, has been shown to significantly reduce liver fat with a 61% responder rate in the 50 mg group in Phase II clinical trial (FASCINATE-1). ASC41 is a liver-targeted prodrug and its active moiety (ASC41-A) is selective for thyroid hormone receptor β (THR-β) and currently, in phase, I study. In addition to three clinical-stage drug candidates against three different NASH targets, Gannex is developing three pre-clinical stage combination therapies, namely ASC40/ASC42, ASC41/ASC42, and ASC40/ASC41 combination therapies.

About Ascletis

Ascletis is an innovative R&D driven biotech and listed on the 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 an FDC treatment of HIV targeting protease. The clinical trial application of ASC09F has been approved.