Gannex Announces US IND Approval of ASC43F, a Class-First Dual-Target Fixed-Dose Combination for NASH

SHANGHAI, October 31, 2021 / PRNewswire / – Gannex Pharma Co., Ltd., a wholly owned company of Ascletis Pharma Inc. (HKEX: 1672), Today Announces Food Approval of the New Investigational Drug (IND) Application and Drug Administration (FDA) and the launch of the worldwide development of ASC43F, a first-in-class fixed-dose combination (FDC) with dual targets of the thyroid hormone receptor beta (THRβ) and farnesoid X receptor ( FXR) for the treatment of non-alcoholic steatohepatitis (NASH).

ASC43F is a single tablet, once daily (qd), FDC of ASC41 and ASC42. ASC41 is an oral THRβ agonist prodrug in clinical development worldwide. Previous Phase I studies in the United States and China showed that AUC41 was well tolerated and significantly reduced low density lipoprotein (LDL-C) cholesterol, triglycerides (TG) and total cholesterol (TC) in overweight and obese subjects with elevated LDL-C , a population characteristic of NASH. ASC42 is a novel, potent, selective, oral nonsteroidal FXR agonist in clinical development worldwide. Phase I clinical data indicated that no pruritus was observed during the 14 day treatment of the 15 mg once daily human therapeutic dose. once daily and 7α-hydroxy-4-cholesten-3-one (C4) were reduced by 91% on day 14 of treatment with 15 mg once daily.

The approval of the US IND was based on efficacy data in the rat NASH model after co-administration of ASC41 and ASC42, where the combination therapy showed significant improvements on serum TG and liver TC, inflammation, bloating, NAFLD Activity Score (NAS) and fibrosis. In addition, data to be presented at the next American Association for Study of Liver Diseases annual conference showed that the dog PK parameters of ASC42 and ASC41A, the active metabolite of ASC41, in / ASC43F tablets remained roughly unchanged from those of single ASC41 and ASC42 tablets.

Dr. Handan it, Scientific Director of Ascletis, said: “NASH is a metabolic syndrome with a complex underlying pathophysiology. Thus, combined treatments with different mechanisms of action and / or different targets are a promising approach to fight against this liver disease. THRβ agonists are believed to reduce liver fat by improving mitochondrial function, while engagement of FXR has potent anti-fibrotic effects in addition to anti-inflammatory effects. Thus, ASC43F may have important effects on liver fat reduction, necro-inflammation and fibrosis with dual THRβ and FXR targeting. “

Melissa Palmer, MD, Gannex Medical Director, said, “We have a very strong NASH pipeline with six assets under development, including three FDC agents, all of which are first class. FDCs may have advantages over monotherapy in potentially reducing adverse events. , improving efficiency and reducing the need for several different pills. “

About Ascletis

Ascletis is an innovative R&D-driven biotechnology listed on the Hong Kong Stock Exchange (1672.HK). Ascletis is committed to developing and commercializing innovative drugs in the areas of NASH, cancer lipid metabolism and oral checkpoint inhibitors, and viral diseases to address unmet medical needs both in China and globally. Led by a management team with deep expertise and proven track record, Ascletis has grown into a fully integrated platform spanning the entire value chain, from discovery and development to manufacturing and marketing. Ascletis has three products on the market and a solid R&D pipeline of drug candidates.

1. NASH: Gannex, a 100% owned company by Ascletis, is 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, THRβ and FXR, and three fixed dose combinations. 2. Cancer lipid metabolism and oral checkpoint inhibitors: a pipeline of oral inhibitors targeting FASN, which plays a key role in cancer lipid metabolism, and a pipeline of next-generation checkpoint inhibitors. small oral PD-L1 molecules. 3. Viral diseases: (1) Hepatitis B: focus on revolutionary therapies for the functional cure of CHB with a PD-L1 antibody injected subcutaneously – ASC22 and Pegasys® as basic drugs. (2) Hepatitis C: successful launch of an all-oral regimen combining ASCLEVIR® and GANOVO® (RDV / DNV scheme). (3) HIV / AIDS: ASC22, an immune therapy to restore HIV-specific immune responses and eventually lead to functional recovery in HIV-infected patients. For more information, please visit www.ascletis.com.

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SOURCE Ascletis Pharma Inc.


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