SHANGHAI — 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 first subject with its NASH drug candidate ASC42, a Farnesoid X Receptor (FXR) agonist, in a U.S. Phase I Trial.
This U.S. phase I trial is a randomized, double-blind, placebo-controlled, single and multiple dose escalation study to evaluate safety, tolerability, pharmacokinetics and pharmacodynamics (biomarkers – FGF19 and C4) of ASC42 in healthy subjects. This trial also investigates the food effect on ASC42 exposure.
ASC42 is an in-house developed，novel non-steroidal, selective and potent FXR agonist. ASC42 received Fast Track designation from the U.S. Food and Drug Administration (FDA) for NASH. The oral tablet formulation of ASC42 has been developed with the in-house proprietary technology and is stable at room temperature.
“We are excited about the initiation of U.S. Phase I trial for ASC42 in 2020,” said Dr. Handan He, Chief Scientific Officer of Ascletis, “This is an important milestone for our R&D team that discovered and developed ASC42, with the potential to be the best-in-class FXR agonist for NASH.”
“As a novel FXR agonist, ASC42 has demonstrated robust preclinical anti-inflammatory and anti-fibrotic effect,” said Melissa Palmer, MD, Chief Medical Officer of Gannex. “Combining ASC42 with ASC40, a fatty acid synthase (FASN) inhibitor or ASC41, a thyroid hormone receptor beta (THR-β) agonist will provide exciting therapeutic options for NASH patients.”
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 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.