Ascletis Pharma reports positive interim results from the expansion cohort of its Phase IIb clinical trial of ASC22 (Envafolimab) for the treatment of chronic hepatitis B (CHB).
This single-blind, randomized, multicenter, placebo-controlled, expansion cohort trial enrolled 49 CHB subjects.
Patients were randomly assigned in a 4:1 ratio to receive ASC22 1 mg/kg or placebo every two weeks for a total of 24 weeks.
Thereafter, they received treatment for an additional 24 weeks during follow-up.
Ascletis administered nucleoside analogs (NA) as background treatment to all trial subjects.
After 24 weeks of treatment, the company conducted an interim evaluation of 25 subjects.
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By Global Data
According to the primary data, 21.1% of subjects in the ASC22 group achieved HBsAg loss, compared with none in the placebo group.
The study also found ASC22 to be safe and well-tolerated, with most adverse reactions associated with the drug being grade 1 or 2.
The programmed cell death ligand 1 (PD-L1) antibody ASC22 is designed to be administered in subcutaneous doses.
Dr. Jinzi Wu, founder, chairman and CEO of Ascletis, said: “While conducting a Phase IIb clinical study of ASC22 (Envafolimab) monotherapy for chronic hepatitis B patients with baseline HBsAg ≤ 100 IU/mL, we are also working with Global partners discuss collaboration on combination therapies to achieve higher functional cure rates for hepatitis B.”
The latest development comes after the company completed a Phase III trial of ASC40 in combination with bevacizumab to treat relapsed glioblastoma.