LONDON (dpa-AFX) - GSK plc (GSK, GSK.L) reported positive outcomes from its two pivotal phase III trials, B-Well 1 and B-Well 2, which evaluated bepirovirsen, an investigational antisense oligonucleotide (ASO) for the treatment of chronic hepatitis B (CHB) in more than 1,800 patients across 29 countries.
The trials successfully met their primary endpoint, with bepirovirsen demonstrating a statistically significant and clinically meaningful functional cure rate. Cure rates were notably higher when bepirovirsen was combined with standard of care compared to standard of care alone, with particularly strong results observed in patients with baseline surface antigen (HBsAg) levels of ?1000 IU/ml. The studies also confirmed an acceptable safety and tolerability profile consistent with earlier findings.
If approved, bepirovirsen could become the first finite, six-month therapeutic option for CHB and serve as a foundation for future sequential treatment strategies.
GSK licensed bepirovirsen from Ionis and collaborated with them on its development. Bepirovirsen has been recognised by global regulatory authorities for its innovation and potential to address significant unmet need in hepatitis B, with Fast Track designation from the US FDA, Breakthrough Therapy designation in China and SENKU designation in Japan.
GSK closed trading on January 6 at $50.56, reflecting an increase of $1.54 or 3.14%. In after-hours trading, the stock edged slightly higher to US$50.62, up $0.06 or 0.12%.
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