Ascletis' ASC22 Shows Potential Of Functional Cure Of Chronic Hepatitis B In Phase IIb Trial

Ascletis Pharma Inc. presented Phase IIb clinical trial results of subcutaneous PD-L1 antibody ASC22 for functional cure of chronic hepatitis B at oral session of EASL ILC 2022 on June 25, 2022, Beijing Time.

The Phase IIb clinical trial results further demonstrated the potential of ASC22+nucleos(t)ide analogs treatment as a functional cure for chronic hepatitis B.

The interim report is based on a randomized, single-blind, multi-center Phase IIb clinical trial to assess the efficacy and safety of ASC22 in treatment of chronic hepatitis B or CHB patients.

In 1.0 mg/kg ASC22 cohort, 75 CHB patients were randomized to be treated with 1.0 mg/kg ASC22 (n=60) or placebo (PBO, n=15) once every 2 weeks plus nucleos(t)ide analogs (NAs) for 24-week and then followed for another 24 weeks.

According to the Phase IIb clinical study results, 42.9% patients with baseline HBsAg =100 IU/mL (n=7) obtained sustained HBsAg loss. ALT flares were observed on 21% patients in ASC22 group (n=48) while none in PBO group.

Patients with ALT flares had more HBsAg reduction. Among the three patients with sustained HBsAg loss, two experienced ALT flares.

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