GSK has announced that its investigational triple-action therapy successfully met primary goals in two pivotal phase 3 trials (B-Well 1 and B-Well 2). Released on 7 January, the data marks a definitive shift toward finite, curative therapies for Chronic Hepatitis B (CHB), a disease currently requiring lifelong viral suppression.
Clinical evidence: defining the functional cure
The B-Well programme, encompassing over 1,800 patients across 29 countries, demonstrated that this investigational therapy significantly outperforms the current standard of care. The latest phase 3 results confirm that the therapy achieved a statistically significant therapeutic effect – defined as the virus remaining undetectable in the blood for at least 24 weeks after treatment ends.
By adding this treatment alongside existing therapies, patients were far more likely to achieve a functional cure, with particularly robust efficacy observed in those with lower baseline viral surface antigen (HBsAg) levels. Crucially, this data supports a transition from lifelong, indefinite medication to a first-of-its-kind, finite six-month treatment course for CHB.
The benefit: from suppression to elimination
GSK’s investigational treatment offers a potential clinical advantage by targeting the disease at its genetic root. Unlike traditional drugs that primarily suppress replication, this candidate employs a unique three-pronged mechanism – RNA destruction, antigen suppression and immune engagement – which eventually allows patients’ own immune systems to regain long-term control of the infection.
Strategic outlook and regulatory timeline
CHB is a leading cause of liver damage, accounting for approximately 56% of liver cancer cases globally. GSK plans to begin global regulatory filings from the first quarter of 2026. Highlighting the development, Tony Wood, Chief Scientific Officer, GSK, said it has the potential to “transform treatment goals for people living with CHB by achieving significant functional cure rates – a first for the disease”.
Furthermore, Brett Monia, CEO, Ionis Pharmaceuticals, partnering with GSK on this study, also issued a statement emphasising that the data has the potential to “bring hope to the millions of people living with CHB” through a first-in-class therapeutic approach.
