Vir Challenges Gilead With Phase II Hepatitis Delta Data

Vir Biotechnology has revealed encouraging outcomes from its Phase II SOLSTICE trial involving a monoclonal antibody aimed at combating the most severe form of hepatitis virus. The San Francisco-based company presented initial findings on Wednesday and plans to provide further details at the 2024 Congress of the European Association for the Study of the Liver on Saturday.

The trial focused on patients with chronic hepatitis delta (HDV). Vir tested its experimental monoclonal antibody, tobevibart, both as a twice-monthly monotherapy and as a monthly subcutaneous injection in combination with elebsiran, a small interfering ribonucleic acid developed in partnership with Alnylam. 

Results from the twice-monthly monotherapy group, which included 11 participants, showed that 55% experienced a reduction in virus levels, and in 18% (two out of 11 participants), the virus was not detectable. In the combination therapy group, all participants reached the lower limit of quantification for virus levels, and in more than half (six out of 11 participants), the virus was undetectable at 24 weeks. Importantly, no serious adverse events or events above grade 2 were reported in any treatment arm.

Hepatitis D can infect individuals already suffering from hepatitis B, significantly increasing the risk of irreversible and life-threatening liver damage. 

"The significant reduction in HDV RNA observed in the preliminary SOLSTICE trial data exceeds any previous therapy reported so far and underscores the potential of tobevibart and elebsiran in addressing this critical unmet need," remarked Tarik Asselah, head of the viral hepatitis unit at INSERM UMR1149, France.

Vir Biotechnology plans to collaborate with regulatory authorities to determine the next steps for bringing its candidate to market. The company aims to compete with Gilead Sciences, which already has an approved HDV treatment in Europe. Gilead acquired this treatment, bulevirtide, through the $1.4 billion acquisition of Myr GmbH in 2020. However, Gilead has encountered difficulties in obtaining U.S. market approval for the treatment.

In 2022, the FDA issued a Complete Response Letter to Gilead’s Biologics License Application (BLA) due to concerns about the manufacturing and delivery of the daily injection. The resubmitted BLA is still under review by the regulatory body.

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