Gannex Announces First Subject Dose in US Drug Interaction Study of FXR Agonist ASC42 for the Treatment of Primary Biliary Cholangitis

— Enrollment of the total 12 subjects is expected to be completed in August 2022

— DDI US ASC42 study expected to be completed by early Q4 2022

— This DDI study and the ongoing Phase II clinical trial in patients with PBC in China will provide more evidence to support upcoming phase III clinical trials in Chinathe United States and the European Union

SHANGHAI, August 15, 2022 /PRNewswire/ — Gannex Pharma Co., Ltd. (“Gannex”), a wholly-owned company of Ascletis Pharma Inc. (HKEX: 1672) today announces that it has completed the first-ever US-based Dosage in Drug Interaction (DDI) study of Farnesoid X receptor (FXR) agonist ASC42 for the treatment of primary biliary cholangitis (PBC). This DDI study is expected to enroll a total of 12 subjects in August 2022 and be completed by early Q4 2022 in the United States The DDI study and the ongoing Phase II clinical trial in patients with PBC in China will provide more evidence to support upcoming phase III clinical trials in Chinathe United States and the European Union for the treatment of PBC.

PBC is a chronic autoimmune cholestatic disease and frequently progresses to liver fibrosis and cirrhosis requiring liver transplantation or resulting in death. In response to the rising incidence, the Asia Pacific Association for the Study of the Liver (APASL) developed the clinical practice guideline on the diagnosis and management of patients with PBC in 2022. The CBP is the focus of particular attention as the incidence and prevalence have shown an increasing trend globally [1].

An epidemiological study indicates that there were approximately 120,000 patients with PBC in the United States in 2014[2]. Ursodeoxycholic acid (UDCA) is the standard treatment for PBC, however, approximately 40% of patients with PBC either have an inadequate response or are unable to tolerate UDCA[3]. For patients with insufficient response or intolerance to UDCA, obeticholic acid (OCA) is the only drug approved in the United States, while it has not been approved in the United States. China Again. Additionally, OCA can cause a significant increase in pruritus and low-density lipoprotein cholesterol (LDL-C) levels.

ASC42 is a novel, selective and potent non-steroidal FXR agonist developed in-house with first-class potential and worldwide intellectual property. A previous Phase I clinical trial in the United States (ClinicalTrials.gov Identifier: NCT04679129) demonstrated that ASC42 could be a potentially best-in-class CBP drug candidate, as LDL-C levels were in the range normal without onset of pruritus, and the target FXR engagement biomarker FGF19 increased by 1780% when AUC42 was dosed at 15 mg once daily (QD) for 14 days of treatment.

Currently FXR agonist ASC42 is in a phase II clinical trial in China. The Phase II study (ClinicalTrials.gov Identifier: NCT05190523) consists of three ASC42 active treatment arms (5 mg, 10 mg, and 15 mg) and one placebo control arm at a ratio of 1:1:1: 1 and is expected to enroll a total of 100 patients who either have an inadequate response or are unable to tolerate UDCA. The duration of treatment is 12 weeks.

Gannex intends to initiate phase III clinical trials in Chinathe United States and the European Union following the completion of the ongoing Phase II clinical trial in China.

“It took us only two months to complete the subject’s first assay after the DDI study application was approved by the US FDA. This rapid progress has, once again, demonstrated the excellence of the execution of our team Gannex is advancing the clinical trials of the FXR agonist ASC42 both China and the United States to meet the unmet medical needs of patients with PBC. We are committed to improving current treatments for PBC and providing more options for patients,” said Dr. Jinzi J. WuFounder, Chairman and CEO of Ascletis.

[1] Lv T, Chen S, Li M, et al. Regional variation and temporal trend in the epidemiology of primary biliary cholangitis: systematic review and meta-analysis. J Gastroenterol Hepatol. 2020;36:1423–1434.
[2] Lu M, Zhou Y, Haller IV, et al. Increased prevalence of primary biliary cholangitis and reduced mortality with treatment [J]. Clin Gastroenterol Hepatol 2018, 16(8): 1342-50 e1. DOI: 10.1016/j.cgh.2017.12.033.
[3] Lindor KD, Bowlus CL, Boyer J, et al. Primary Biliary Cholangitis: 2018 Practice Guideline from the American Association for the Study of Liver Diseases [J]. Hepatology 2019, 69(1): 394-419. DOI: 10.1002/hep.30145.

About Ascletis

Ascletis is an innovative, R&D-driven biotech company listed on the Hong Kong Stock Exchange (1672.HK), spanning the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and proven track record, Ascletis focuses on three therapeutic areas with unmet medical needs from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH ) and oncology. Through excellent execution, Ascletis is rapidly advancing its drug pipeline with the aim of dominating the global competition. To date, Ascletis markets three products, namely ritonavir tablets, GANOVO® and ASCLEVIR®, and 20 drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (functional HBV cure), ASC10 and ASC11 (oral small molecules for the treatment of COVID-19), ASC40 (recurrent glioblastoma), ASC42 (PBC, primary biliary cholangitis) and ASC40 (acne ).

For more information, visit www.ascletis.com.

SOURCEAscletis Pharma Inc.

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