Clinical TrialMay 28, 2026, 12:51 PM
Ionis Partner GSK Reports Positive Phase 3 Bepirovirsen Data for CHB
AI Summary
Ionis Pharmaceuticals announced that its partner, GSK, reported positive pivotal Phase 3 data for bepirovirsen, an investigational antisense oligonucleotide for chronic hepatitis B (CHB). The B-Well 1 and B-Well 2 trials showed a statistically significant 19% functional cure rate in the overall study population and 26% in patients with lower viral activity, significantly outperforming the standard of care's less than 1% rate. Bepirovirsen is currently under priority review by the FDA and other global regulatory authorities, with first decisions anticipated in Q3 2026, positioning Ionis for potential future milestone payments and 10-12% tiered royalties on net sales.
Key Highlights
- Bepirovirsen achieved a 19% functional cure rate in the overall CHB study population.
- A 26% functional cure rate was observed in patients with baseline HBsAg "u2264"1000 IU/ml.
- Current standard of care achieves functional cure rates in less than 1% of patients.
- 49% of recipients achieved qHBsAg ",u2264"100 IU/mL one year post-treatment in exploratory analysis.
- Bepirovirsen is under priority review by the US FDA with Breakthrough and Fast Track Designation.
- GSK anticipates first regulatory decisions in Q3 2026.
- Ionis is eligible for 10-12% tiered royalties on net sales of bepirovirsen.
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