GSK Announces Positive Phase III Results for Bepirovirsen in Chronic Hepatitis B, Plans Regulatory Submissions in 2026

On January 7, GSK announced its two pivotal Phase III trials, B-Well 1（NCT05630807）And B-Well 2（NCT 05630820）Achieved positive results.

Screenshot source: Corporate official website

B-Well 1 and B-Well 2 Trials Evaluate Antisense Oligonucleotides (ASO) Bepirovirsen TreatmentChronic Hepatitis B (CHB) The efficacy, with more than 1,800 patients from 29 countries participating.

Bepirovirsen（GSK836）It is an ASO jointly developed by GSK and Ionis, which can inhibit the expression of HBsAg protein while stimulating immune response through TLR8 to activate the immune system to clear viruses from the circulatory system.

The results showed that the B-Well trial met the primary endpoint,Bepirovirsen Shows Statistically and Clinically Significant Functional Cure Rate。The functional cure rate of Bepirovirsen combined with standard treatment is significantly higher than that of standard treatment alone. The results of all ranked endpoints are statistically significant, including baseline surface antigen.（HBsAg）Patients with ≤1000 IU/ml, the efficacy in this group of patients is more significant.

Moreover, Bepirovirsen demonstrated an acceptable safety and tolerability profile, consistent with findings reported in other studies.

The full results will be submitted for presentation at an upcoming scientific conference, published in a peer-reviewed journal, and used to support regulatory submissions to health authorities worldwide for the approval of Bepirovirsen. If approved, Bepirovirsen could become the first finite six-month treatment option for chronic hepatitis B and pave the way for future sequential treatment strategies.

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