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, which shows Song Dynasty New and positive progress has been made in the functional cure of CHB and the treatment of NASH. Chronic hepatitis B and non-alcoholic steatohepatitis remain a significant unmet medical need worldwide.about 86 million people
|
(1)Lim JK, Nguyen MH, Kim WR, et al.Prevalence of chronic hepatitis B virus infection |
|
(2) Xie Y., Li Ming, Ou X. et al. HBeAg positive and HBsAg patients |
|
(3) Kara S. Coffin et al. “Clinical Outcomes and Quantitative HBV Surface Antigen Levels in Different Chronic Hepatitis B Patients |
|
(4) Estes, Chris et al. “Modeling NAFLD disease burden |
About ASLD in the United States
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 Song Dynasty
Song Dynasty It is an innovative R&D-driven biotechnology company listed on the Science and Technology Innovation Board. 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, Song Dynasty A global perspective focuses on three therapeutic areas with unmet medical needs: viral diseases, non-alcoholic steatohepatitis (NASH), and oncology. Through excellent execution, Song Dynasty Rapidly advancing its drug pipeline, aiming to stay ahead of global competition. So far, Song Dynasty It has multiple drug candidates in its pipeline. 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.
View original text: https://www.prnewswire.com/news-releases/ascletis-announces-poster-presentations-at-aasld-annual-meeting-2023-include-a-late-writing-abstract-of-interim-from Results from the Phase IIB expansion cohort of -asc22-functional cure-chb-301985282.html
source Ascletis Pharmaceuticals