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Ascletis Announces Poster Presentations at AASLD Annual Meeting 2023 Including a Late-Breaking Abstract of Interim Results from Phase IIb Expansion Cohort of ASC22 for Functional Cure of CHB

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HANGZHOU and SHAOXING, China, Nov. 12, 2023 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces late-breaking abstract poster presentation of interim results from Phase IIb expansion cohort of ASC22 (Envafolimab) for functional cure of chronic hepatitis B (CHB), and abstract poster presentation of Phase I study results of ASC41 for treatment of non-alcoholic steatohepatitis (NASH) at The Liver Meeting® 2023 of the American Association for the Study of Liver Diseases (AASLD).

Late-Breaking Abstract Poster Presentation:

Poster ID: 5052-C

Title

HBsAg Loss in Chronic Hepatitis B Patients After 24-Week Treatment with Subcutaneously Administered PD-L1 Antibody ASC22 (Envafolimab): Interim Results from a Phase IIb Expansion Cohort

Background:

An expansion cohort of 49 patients with baseline hepatitis B surface antigen (HBsAg)≤100 IU/mL has been initiated to explore sustained HBsAg loss in this specific population.

Methods:

ASC22 expansion cohort enrolled 49 patients with baseline HBsAg≤100 IU/mL. At a ratio of approximately 4:1, patients are subcutaneously administered with 1.0 mg/kg ASC22 once every two weeks (Q2W) (ASC22 cohort, n=40) or placebo (n=9) for 24-week treatment in background Nucleot(s)ide Analogues (NAs). After treatment, the follow-up period is 24 weeks. Patients who achieve HBsAg loss at completion of 24-week treatment of ASC22 are expected to discontinue background NAs for the follow-up. The primary efficacy endpoint is HBsAg reduction. Interim analysis was conducted when approximately 50% of enrolled patients completed 24-week treatment of ASC22 or placebo.

Conclusion:

ASC22 monotherapy with background NAs showed statistically significant HBsAg reduction and 21.1% (4/19) HBsAg loss after 24-week treatment. Together with the acceptable safety profile and convenient subcutaneous injections, ASC22 demonstrated potential as a promising immune-therapy for CHB.

Poster Presentation:

Poster ID: 2401-C

Title

ASC41, a Thyroid Hormone Receptor β Agonist, Showed Little Drug Interaction, Significant Lipid Reduction and Comparable Pharmacokinetic Profiles among Chinese and US Healthy Subjects and Patients with Non-alcoholic Fatty Liver Disease (NAFLD): Results from Two Phase 1 Studies

Background:

Results of ASC41 drug-drug interaction (DDI) study in US healthy subjects and pharmacokinetic (PK), safety and pharmacodynamic (PD) in Chinese healthy subjects or US subjects with non-alcoholic fatty liver disease (NAFLD) have been reported.

Methods:

NCT04527250 was a randomized, double-blind, placebo-controlled study to evaluate safety, tolerability, PK and PD of single and multiple ascending oral doses of ASC41. NCT04845646 was an open label, DDI study to evaluate effect of itraconazole (CYP3A strong inhibitor) and phenytoin (CYP3A strong inducer) on PK of ASC41 following a single dose of 5 mg ASC41 tablet and PK in NAFLD patients.

Conclusion:

PK of ASC41-A, the active metabolite of ASC41, was comparable among US and Chinese healthy subjects and NAFLD patients. ASC41 demonstrated significant reductions of lipids. ASC41 exhibited satisfactory safety and tolerability. Drug-drug interactions of ASC41/ASC41-A with strong CYP3A4 inhibitor or inducer were low, showing competitiveness to other thyroid hormone receptor β (THRβ) agonists in the late stage clinical development. It is unlikely that there will be clinically significant drug-drug interactions between ASC41/ASC41-A and the most frequently used antidepressants and statins, indicating broad application in patients with NASH. ASC41 is currently in a 52-week Phase 2 trial to treat biopsy-confirmed NASH patients.

“It’s a great honor that the interim results from Phase IIb expansion cohort of ASC22 for CHB were presented as the late-breaking abstract poster and the results of the Phase I study of ASC41 for NASH were also presented as abstract poster at The Liver Meeting® 2023 of AASLD, which demonstrate that Ascletis has achieved new positive progress on CHB functional cure and treatment for NASH. CHB and NASH remain to be significantly unmet medical needs globally. Approximately 86 million people in China were infected with hepatitis B virus (HBV) [1], including 15%-22% of the patients with HBsAg≤100 IU/mL[2][3]. It is estimated that there will be approximately 48 million NASH patients in China in 2030 [4]. No NASH medicine has been approved yet. We will accelerate the clinical studies and enhance our competitiveness in liver diseases.” said Dr. Jinzi J. Wu, Founder, Chairman and CEO of Ascletis.

[1]Lim J K, Nguyen M H, Kim W R, et al. Prevalence of Chronic Hepatitis B Virus Infection in the United States [J]. The American journal of gastroenterology 2020, 115(9): 1429-38.



[2]Xie, Y., Li, M., Ou, X. et al. HBeAg-positive patients with HBsAg < 100 IU/mL and negative HBV RNA have lower risk of virological relapse after nucleos(t)ide analogues cessation. J Gastroenterol 56, 856–867 (2021).



[3]Coffin, Carla S et al. “Clinical Outcomes and Quantitative HBV Surface Antigen Levels in Diverse Chronic Hepatitis B Patients in Canada: A Retrospective Real-World Study of CHB in Canada (REVEAL-CANADA).” Viruses vol. 14,12 2668. 29 Nov. 2022



[4]Estes, Chris et al. “Modeling NAFLD disease burden in China, France, Germany, Italy, Japan, Spain, United Kingdom, and United States for the period 2016-2030.” Journal of hepatology vol. 69,4 (2018): 896-904.

About AASLD

American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and health care professionals committed to preventing and curing liver disease. AASLD fosters research that leads to improved treatment options for millions of liver disease patients. AASLD advances the science and practice of hepatology through educational conferences, training programs, professional publications, and partnerships with government agencies and sister societies.

About Ascletis

Ascletis is an innovative R&D driven biotech listed on the Hong Kong Stock Exchange (1672.HK), covering the entire value chain from discovery and development to manufacturing and commercialization. Led by a management team with deep expertise and a 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 rapidly advances its drug pipeline with an aim of leading in global competition. To date, Ascletis has multiple drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).

For more information, please visit www.ascletis.com.

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