HANGZHOU and SHAOXING, China, November 13, 2023 /PRNewswire/ — Ascletis Pharma Inc. (HKEX: 1672, “Ascletis”) today announces late-breaking abstract poster presentation of interim results from the ASC22 Phase IIb Expansion Cohort (Envafolimab) for Functional Cure of Chronic Hepatitis B (CHB), and Abstract Poster Presentation of Phase I Study Results of ASC41 for the Treatment of Nonalcoholic Steatohepatitis (NASH) at Liver Meeting® 2023 from the American Association for the Study of Liver Diseases (AASLD).
Last minute abstract poster presentation:
Poster ID: 5052-C
Title:
Loss of HBsAg in Patients With Chronic Hepatitis B After 24 Weeks Treatment With PD-L1 Antibody ASC22 (Envafolimab) Administered Subcutaneously: Interim Results from a Phase IIb Expansion Cohort
Background:
An expansion cohort of 49 patients with hepatitis B surface antigen (HBsAg) ≤ 100 IU/mL at baseline was initiated to explore sustained loss of HBsAg in this specific population.
Methods :
The ASC22 expansion cohort enrolled 49 patients with baseline HBsAg ≤ 100 IU/mL. In a ratio of approximately 4:1, patients receive 1.0 mg/kg ASC22 subcutaneously once every two weeks (every 2 weeks) (ASC22 cohort, n=40) or placebo (n=9) for 24 weeks of Nucleot(s)ide Analogues (NA) background treatment. After treatment, the follow-up period is 24 weeks. Patients who achieve HBsAg loss at the end of 24 weeks of ASC22 treatment should discontinue background NAs for follow-up. The main measure of effectiveness is the reduction of HBsAg. An interim analysis was performed when approximately 50% of enrolled patients completed 24 weeks of treatment with ASC22 or placebo.
Conclusion:
ASC22 monotherapy with background NAs showed a statistically significant reduction in HBsAg and a 21.1% (4/19) loss of HBsAg after 24 weeks of treatment. Combined with an acceptable safety profile and convenient subcutaneous injections, ASC22 has demonstrated its potential as a promising immunotherapy for CHB.
Poster presentation:
Poster ID: 2401-C
Title:
ASC41, a thyroid hormone receptor β agonist, showed few drug interactions, significant lipid reduction, and comparable pharmacokinetic profiles in healthy Chinese and American subjects and patients with nonalcoholic fatty liver disease (NAFLD) : results of two phase 1 studies
Background:
Results of the ASC41 Drug Interaction (DDI) Study in Healthy US Subjects and Pharmacokinetic (PK), Safety and Pharmacodynamic (PD) Study in Chinese Healthy Subjects or US Subjects With Steatosis non-alcoholic liver disease (NAFLD) have been reported.
Methods:
NCT04527250 was a randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, pharmacokinetics, and PD of single and multiple ascending oral doses of ASC41. NCT04845646 was an open-label DDI study to evaluate the effect of itraconazole (strong CYP3A inhibitor) and phenytoin (strong CYP3A inducer) on ASC41 pharmacokinetics after a single 5 mg dose of ASC41 tablet and pharmacokinetics in NAFLD patients.
Conclusion:
The pharmacokinetics of ASC41-A, the active metabolite of ASC41, was comparable in healthy American and Chinese subjects and in NAFLD patients. ASC41 demonstrated significant reductions in lipids. ASC41 exhibited satisfactory safety and tolerability. Drug interactions of ASC41/ASC41-A with a strong CYP3A4 inhibitor or inducer were weak, showing competitiveness with other thyroid hormone receptor (THR) β–β) agonists at the advanced stage of clinical development. There are unlikely to be clinically significant drug interactions between ASC41/ASC41-A and the most commonly used antidepressants and statins, indicating wide application in patients with NASH. ASC41 is currently in a 52-week Phase 2 trial to treat biopsy-proven NASH patients.
“It is a great honor that the interim results of the ASC22 Phase IIb expansion cohort for CHB were presented as a late-breaking abstract poster and that the results of the Phase I study on ASC41 for NASH were also presented as an abstract poster at the Liver Meeting.® 2023 from the AASLD, which demonstrate that Ascletis has made further positive progress in the functional cure of CHB and the treatment of NASH. CHB and NASH remain largely unmet medical needs globally. About 86 million people China have been infected with hepatitis B virus (HBV) [1]including 15 to 22% of patients with HBsAg ≤ 100 IU/mL[2][3]. It is estimated that there will be approximately 48 million NASH patients worldwide. China in 2030 [4]. No NASH drugs have yet been approved. We will accelerate clinical studies and improve our competitiveness in the field of liver diseases,” said Dr. Jinzi J. WuFounder, Chairman and CEO of Ascletis.
[1]Lim JK, Nguyen MH, Kim WR, 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 a lower risk of virological relapse after stopping nucleos |
[3]Coffin, Carla S et al. “Clinical findings and quantitative HBV surface antigen levels in various patients with chronic hepatitis B in Canada: a real-world retrospective study of CHB in Canada (REVEAL-CANADA). » Virus Flight. 14.12 2668. Nov 29, 2022 |
[4]Estes, Chris et al. “Modeling the burden of NAFLD disease in China, France, Germany, Italy, Japan, Spain, the United Kingdom and the United States for the period 2016-2030.” Journal of Hepatology flight. 69.4 (2018): 896-904. |
About AASLD
The American Association for the Study of Liver Diseases (AASLD) is the leading organization of scientists and health care professionals committed to the prevention and cure of liver disease. AASLD promotes research that leads to better treatment options for millions of patients with liver disease. 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 biotechnology 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 of unmet medical need from a global perspective: viral diseases, nonalcoholic steatohepatitis (NASH), and oncology. Through excellent execution, Ascletis is rapidly advancing its drug pipeline with the goal of becoming a leader in global competition. To date, Ascletis has several drug candidates in its R&D pipeline. The most advanced drug candidates include ASC22 (functional cure of CHB), ASC40 (acne), ASC40 (recurrent glioblastoma), ASC40 (NASH), ASC41 (NASH) and ASC61 ( advanced solid tumors).
For more information, please visit www.ascletis.com.
SOURCE Ascletis Pharma Inc.