Ionis partner GSK announces bepirovirsen achieves unprecedented functional cure rates with potential to redefine treatment for chronic hepatitis B
GSK announced pivotal Phase 3 data for bepirovirsen, an investigational therapy for chronic hepatitis B licensed from Ionis. The pooled results from the B-Well 1 and B-Well 2 trials showed a 19% functional cure rate in the overall population and 26% in patients with lower viral activity, compared to 0% in the placebo group. The data met the primary endpoints with high statistical significance (p<0.001). In an exploratory analysis, 49% of recipients achieved a surface antigen level of ≤100 IU/mL one year after treatment ended, a marker linked to improved long-term outcomes.
Key figures
- Drug Name
- bepirovirsen
- Phase Of Trial
- Phase 3
- Placebo cure rate
- 0%
- Global chb population
- 240 million
- Functional cure rate overall
- 19%
- Surface antigen reduction 1yr
- 49%
- Functional cure rate low viral
- 26%
- Sustained dna suppression overall
- 23%
- Sustained dna suppression low viral
- 31%
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