Drugmaker GSK plc (GSK) on Tuesday announced positive Phase III trial results for investigational hepatitis B treatment bepirovirsen.
Pooled data from the Phase III B-Well 1 and B-Well 2 trials showed that 19% of patients receiving bepirovirsen achieved a functional cure, compared with 0% in the placebo group.
Among patients with lower baseline viral activity, defined as hepatitis B surface antigen levels of 1,000 IU/mL or less, the functional cure rate increased to 26%, also versus 0% for placebo.
GSK said current standard therapies typically require lifelong treatment and achieve functional cure rates in less than 1% of patients.
The company also reported that 23% of all bepirovirsen-treated patients achieved sustained viral suppression at week 72 after stopping therapy, compared with none in the placebo group.
The trials enrolled more than 1,800 participants globally and demonstrated a safety profile consistent with previous studies. The most common side effects included injection site reactions and temporary increases in liver enzyme levels.
Bepirovirsen is currently under priority review by the U.S. Food and Drug Administration and is also under regulatory review in Europe, Japan, and China.
GSK said it expects the first regulatory decisions in the third quarter of 2026.
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