Shots:
- GSK has reported data from the P-III (B-Well 1 & B-Well 2) trials assessing bepirovirsen vs PBO in nucleos(t)ide analogue-treated pts with CHB & baseline HBsAg ≤3000 IU/ml. Bepirovirsen is under regulatory review in the US, EU, China & Japan
- Pooled data showed a 19% functional cure rate (1EP) in the overall population (233/1,220 vs 0/614; B-Well 1: 20% vs 0%; B-Well 2: 19% vs 0%) & 26% in pts with HBsAg ≤1000 IU/ml (2EP: 200/768 vs 0/393; B-Well 1: 25% vs 0%; B-Well 2: 28% vs 0%)
- In an exploratory analysis, 49% of bepirovirsen recipients achieved qHBsAg ≤100 IU/mL 1yr. post-treatment, while a key 2EP showed sustained HBV DNA <LLOQ at Wk. 72 in 23% of all recipients & 31% with HBsAg ≤1000 IU/mL after stopping treatment at Wk. 48
Ref: GSK | Image: GSK | Press Release
Related News: The US FDA Grants Priority Review and Breakthrough Therapy Designation to GSK’s Bepirovirsen for Chronic Hepatitis B
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