Hangzhou and Shaoxing, China, November 13, 2023 /PRNewswire/ — Ascletis Pharmaceuticals, Inc. (HKEX: 1672, “Ascletis”) today announced an updated abstract poster presentation demonstrating the functional cure of ASC22 (Envafolimab) in the Phase IIb expansion cohort of chronic hepatitis B (CHB) Interim results and abstract poster presenting results from Phase I study of ASC41 in non-alcoholic steatohepatitis (NASH) at liver conference® American Association for the Study of Liver Diseases (AASLD) 2023.
Latest abstract poster presentation:
Poster ID: 5052-C
title:
HBsAg loss after 24 weeks of subcutaneous administration of the PD-L1 antibody ASC22 (Envafolimab) in patients with chronic hepatitis B: interim results from the 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 loss of HBsAg in this specific population.
method:
The ASC22 expansion cohort included 49 patients with baseline HBsAg ≤ 100 IU/mL. Patients received 1.0 mg/kg ASC22 (ASC22 cohort, n=40) or placebo (n=9) subcutaneously every two weeks (Q2W) or placebo (n=9) in an approximate 4:1 ratio on background Nucleot for 24 weeks. s)ide analog (NA). After treatment, the follow-up period was 24 weeks. Patients who achieve HBsAg loss after completing 24 weeks of ASC22 treatment are expected to have background NA discontinued for follow-up. The primary efficacy endpoint was HBsAg reduction. An interim analysis was conducted when approximately 50% of enrolled patients completed 24 weeks of treatment with ASC22 or placebo.
in conclusion:
ASC22 monotherapy against background NA showed statistically significant HBsAg reduction, with HBsAg loss of 21.1% (4/19) after 24 weeks of treatment. Coupled with acceptable safety and convenient subcutaneous administration, ASC22 demonstrates potential as an immunotherapy for chronic hepatitis B.
Poster presentation:
Poster ID: 2401-C
title:
ASC41 is a thyroid hormone receptor beta agonist that shows few drug interactions, significant lipid-lowering effects, and comparable efficacy in healthy subjects and non-alcoholic fatty liver disease (NAFLD) patients in China and the United States Pharmacokinetic characteristics of: results from two phase 1 studies
background:
Results of ASC41 drug interaction (DDI) studies in healthy US subjects have been reported, as well as pharmacokinetics (PK), safety and Drug efficacy (PD) study results.
method:
NCT04527250 is a randomized, double-blind, placebo-controlled study designed to evaluate the safety, tolerability, PK and PD of single and multiple ascending oral doses of ASC41. NCT04845646 is an open-label, DDI study designed to evaluate the effects of itraconazole (a strong inhibitor of CYP3A) and phenytoin (a strong inducer of CYP3A) on ASC41 PK following a single dose of 5 mg ASC41 tablets and PK in patients with NAFLD.
in conclusion:
The PK of ASC41-A, the active metabolite of ASC41, was comparable in US and Chinese healthy subjects and NAFLD patients. ASC41 showed significant lipid reduction. ASC41 demonstrated satisfactory safety and tolerability. ASC41/ASC41-A has low drug interactions with strong CYP3A4 inhibitors or inducers and has been shown to interact with other thyroid hormone receptor beta (THR–β) agonists are in late stages of clinical development. Clinically significant drug interactions between ASC41/ASC41-A and the most commonly used antidepressants and statins are unlikely, suggesting their widespread use in patients with NASH. ASC41 is currently in a 52-week Phase 2 trial for the treatment of patients with biopsy-confirmed NASH.
“It is a great honor that the interim results of the Phase IIb expansion cohort of ASC22 for the treatment of CHB are presented as the latest abstract poster, and the results of the Phase I study of ASC41 for the treatment of NASH are also presented as abstract posters at the Liver Conference® AASLD 2023 shows that Ascletis has made new positive progress in the functional cure of CHB and NASH treatment. Chronic hepatitis B and non-alcoholic steatohepatitis remain a significant unmet medical need worldwide.about 86 million people China Infected with hepatitis B virus (HBV) (1)among which 15%-22% of patients have HBsAg ≤ 100 IU/mL(twenty three).It is estimated that there will be approximately 48 million NASH patients in the United States China 2030 (4). No NASH drugs are currently approved. We will accelerate clinical research and enhance competitiveness in the field of liver diseases. ” Wu Jinzifounder, chairman and CEO of Ascletis.
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(1)Lim JK, Nguyen MH, Kim WR, et al. Prevalence of chronic hepatitis B virus infection in the United States (J). American Journal of Gastroenterology 2020, 115(9): 1429-38. |
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(2) Xie Y., Li Ming, Ou X. et al. HBeAg-positive patients with HBsAg < 100 IU/mL and HBV RNA negative are at lower risk for virologic relapse after discontinuation of nucleos |
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(3) Kara S. Coffin et al. “Clinical outcomes and quantitative HBV surface antigen levels in diverse Canadian patients with chronic hepatitis B: the retrospective real-world study of chronic hepatitis B in Canada (REVEAL-CANADA).” Virus roll. 14.12 2668. November 29, 2022 |
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(4) Estes, Chris et al. “Modeling the disease burden of NAFLD in China, France, Germany, Italy, Japan, Spain, the United Kingdom, and the United States from 2016 to 2030.” Journal of Hepatology roll. 69.4 (2018): 896-904. |
About ASLD in the United States
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and health care professionals dedicated to preventing and treating liver disease. AASLD is dedicated to advancing research to provide better treatment options for the millions of people living with liver disease. AASLD advances the science and practice of hepatology through educational meetings, training programs, professional publications, and collaboration with government agencies and sister societies.
About Songli
Ascletis is an innovative R&D-driven biotech company 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 proven track record, Ascletis focuses on three therapeutic areas with unmet medical need from a global perspective: viral diseases, non-alcoholic steatohepatitis (NASH) and Oncology. Through superior execution, Ascletis rapidly advances its pharmaceutical pipeline and strives to stay ahead of global competition. Ascletis has multiple drug candidates in its pipeline to date. The most advanced drug candidates include ASC22 (CHB functional cure), ASC40 (acne), ASC40 (relapsed glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 (advanced solid tumors).
For more information, please visit www.ascletis.com.
Source: Ascletis Pharmaceuticals, Inc.