GSK Prioritizes Bepirovirsen as Potential Functional Cure for Hepatitis B, Discontinues Other Candidates

GSK is doubling down on its efforts to develop bepirovirsen as a potential functional cure for hepatitis B, while simultaneously discontinuing work on other candidates in its infectious disease pipeline. The pharmaceutical giant's strategic shift was revealed during a recent media call discussing the company's fourth-quarter and full-year earnings.

Bepirovirsen Takes Center Stage

CEO Emma Walmsley emphasized the company's focus on bepirovirsen, an antisense oligonucleotide licensed from Ionis Pharmaceuticals in 2019 for $25 million upfront. GSK is aiming for regulatory approval for chronic hepatitis B as early as next year. Unlike current oral antiviral therapies that merely suppress the virus, bepirovirsen holds promise as a functional cure, potentially reducing hepatitis B virus DNA and viral proteins to undetectable levels.

Pipeline Restructuring

In a significant move, GSK has discontinued development of GSK3528869, another potential functional cure for hepatitis B. The decision came after a phase 1/2 chronic hepatitis B study was terminated in December due to failure to meet efficacy endpoints. The study had explored various dose levels and sequences, including a viral vector encoding hepatitis B protein antigens and immune-boosting vaccines with adjuvants.

GSK is not alone in facing setbacks in hepatitis B drug development. Other pharmaceutical companies, including Roche, Altimmune, and Ascletis Pharma, have recently axed or dropped hepatitis B candidates after disappointing clinical results.

Ongoing Hepatitis B Research

Despite the setbacks, GSK maintains a diverse portfolio of hepatitis B treatments in clinical development. These include:

• GSK5637608, a hepatitis B virus-targeted siRNA
• GSK3965193, a PAPD5/PAPD7 inhibitor
• GSK5251738, a TLR8 agonist

Additional Pipeline Updates

GSK also announced the removal of VH4004280, an HIV capsid protein inhibitor, from its phase 2 pipeline. However, the company continues to pursue VH3739937, another HIV capsid protein inhibitor currently in multiple clinical trials.

In the tuberculosis arena, GSK has discontinued the phase 1-stage GSK2556286, designed to inhibit intracellular growth of Mycobacterium tuberculosis. The company's tuberculosis pipeline still includes ganfeborole, alpibectir, and sanfetrinem cilexetil, targeting various aspects of the disease.

Walmsley reaffirmed GSK's commitment to strategic growth through "targeted business development," citing the recent acquisition of Boston-based cancer-focused biotech IDRx as an example of the company's M&A strategy.