Particle.news
Download on the App Store

GSK and Ionis Report Phase 3 Success for Hepatitis B Drug, Plan Q1 Filings

A finite six‑month regimen raises hopes for a functional cure in a disease usually managed with lifelong antivirals.

Overview

  • Two pivotal B-Well studies met primary endpoints, with bepirovirsen plus standard care delivering a statistically significant, clinically meaningful functional cure rate over standard care alone.
  • The companies did not disclose exact functional cure percentages, with full datasets slated for a scientific meeting and peer‑reviewed publication.
  • More than 1,800 patients across 29 countries were enrolled, and the safety and tolerability profile was described as acceptable and consistent with earlier studies.
  • Bepirovirsen is intended as a six‑month course that aims to suppress virus and surface antigen to undetectable levels, potentially enabling patients to avoid long‑term therapy.
  • Analysts called the readout encouraging yet cautioned that adoption and labeling hinge on detailed data; GSK projects over £2 billion in peak sales as Ionis remains eligible for milestone payments and tiered royalties.