Clinical-stage biotechnology company Virion Therapeutics, LLC announced on Friday that it has completed enrolment in the first two cohorts of its Phase 1b clinical trial evaluating VRON-0200 for a functional cure of chronic hepatitis B (HBV).

A total of 27 chronically HBV-infected patients on nucleos(t)ide antiviral therapy received either a single Prime or Prime-Boost intramuscular injection of VRON-0200. Previous data demonstrated that a single VRON-0200 injection was safe, well tolerated, and capable of inducing immune responses and anti-HBV activity despite impaired immunity in most patients prior to treatment.

A third cohort is now enrolling to evaluate VRON-0200 in combination with investigational anti-HBV agents elebsiran and tobevibart, with randomized dosing schedules. The study is designed as a multi-centre, open-label trial to assess safety, tolerability, immunogenicity and clinical measures in non-cirrhotic, chronic HBV patients. Inclusion criteria include patients with controlled HBV DNA and specific HBsAg levels on nucleos(t)ide therapy.

VRON-0200 leverages checkpoint modification to amplify and broaden T cell responses, aiming for improved viral control and a functional cure. Chronic HBV remains a significant global health issue, affecting 296 million people and causing 820,000 deaths annually, with no cure available and current therapies requiring lifelong use.