Ascletis announces the assay of the first cohort of healthy subjects in the FXR Agonist ASC42 transition study for the indication of chronic hepatitis B in China

–This bridging study to select doses for the phase II trial in China in patients with chronic hepatitis B (CHB)

– ASC42 clinical trials are ongoing in the United States and China for non-alcoholic steatohepatitis (NASH) and CHB.

HANGZHOU and SHAOXING, China, July 12, 2021 / PRNewswire / – Ascletis, Inc. (HKEX: 1672) today announced the assay of the first cohort of healthy subjects in the transition study ASC42 in China for the CHB indication. ASC42 is a novel, potent, selective, non-steroidal FXR agonist developed in-house with best-in-class potential.

At June 7, 2021, Ascletis announced that the China National Medical Products Administration (NMPA) has approved the Investigational New Drug Application (IND) for ASC42 to conduct clinical trials in China for the CHB indication. (Details referring to the press release: https://www.ascletis.com/news_detail/175/id/503.html)

At June 16, 2021, Gannex, a wholly owned company of Ascletis, announced the first positive results of ASC42 on the safety biomarkers and pharmacodynamics of the US phase I trial in the NASH indication. The data indicated that there was no pruritus observed during the 14-day treatment of the 15 mg once daily human therapeutic dose and no elevations in alanine aminotransferase (ALT) and aspartate aminotransferase ( ASAT) appeared during treatment for 14 days, once a day. with 15 mg. (Details referring to the press release: https://www.ascletis.com/news_detail/175/id/507.html)

Based on pharmacokinetic data from the phase I ASC42 trial in 64 healthy subjects in the United States, the transition study to China is a randomized, placebo-controlled, double-blind, single-dose escalating study (5 mg and 15 mg) in 30 healthy subjects receiving ASC42 or a corresponding placebo (ClinicalTrials.gov Identifier: NCT04679129). The objective of the transition study is to select the doses for the next phase II trial in China in patients with HCB.

As an FXR agonist, ASC42 has a unique mechanism of action against hepatitis B virus (HBV): ASC42 inhibits transcription of HBV cDNA into HBV RNA, which in turn inhibits the transcription of HBV cDNA into HBV RNA. tour inhibits the translation of HBV RNA to HBsAg. ASC42 may also reduce the stability of HBV cccDNA. Both in vitro primary human hepatocyte cells (PHH) and in vivo Studies in AAV / HBV mice demonstrated that ASC42 significantly inhibited serum hepatitis B surface antigen (HBsAg) and HBV pregenomic RNA (pgRNA), indicating that ASC42 has a therapeutic potential to functionally cure CHB.

“We are delighted to move the FXR agonist ASC42 to the CHB indication,” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis, “Dosing the first cohort subject in China for the CHB indication is only achieved one month after receiving IND approval from the Chinese NMPA. This once again demonstrates the execution excellence of our clinical development team. “

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 fields of NASH, cancer lipid metabolism and oral checkpoint inhibitors, viral hepatitis and HIV / AIDS for unmet medical needs 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 seventeen drug candidates or combined therapies in R&D (including eleven developed in-house). 1. NASH: Gannex, a company 100% owned by 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 combination therapies. 2. Cancer lipid metabolism and oral checkpoint inhibitors: focus on a pipeline of oral inhibitors targeting FASN which plays a key role in cancer lipid metabolism and a pipeline of oral inhibitors of small molecules PD-L1 in as next generation checkpoint inhibitors. 3. Viral hepatitis: (i) Hepatitis B: focus on revolutionary therapies for the clinical cure of HBV with the PD-L1 antibody injected subcutaneously – ASC22 and Pegasys® as basic drugs. (ii) Hepatitis C: successful launch of all oral regimens of the ASCLEVIR® and GANOVO® combination (RDV / DNV regimen); and the fixed dose combination (FDC) ASC18 is an improved version of the RDV / DNV regimen with a completed transition study. 4. HIV / AIDS: ASC09F is a CDF protease treatment targeting HIV. The clinical trial application for ASC09F has been approved. For more information, please visit www.ascletis.com.

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SOURCE ASCLETIS PHARMACEUTICALS CO., LTD./PRN ASIA


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