Vir Biotechnology to Present SOLSTICE Data at EASL Congress 2024

VIR BIOTECHNOLOGY, Inc. (Nasdaq: VIR) has announced a significant update regarding their Phase 2 SOLSTICE hepatitis delta trial. Initially planned as a late-breaker poster, the presentation has now been upgraded to an oral presentation at the EASL Congress 2024. This annual meeting of the European Association for the Study of the Liver will occur from June 5-8 in Milan, Italy. The data from the SOLSTICE trial will be presented on June 8. Moreover, Vir Biotechnology plans to host an investor conference call on June 5 to discuss the new findings from the trial.

The SOLSTICE trial (NCT05461170) is currently assessing the safety, tolerability, and efficacy of two investigational treatments, tobevibart and elebsiran, for individuals with chronic hepatitis delta. The company will present data on participants who have received 12 and 24 weeks of chronic suppressive treatment. Additionally, the 48-week treatment data on the efficacy and safety of both tobevibart and elebsiran will also be shared. This data includes patients who were previously part of the 2023 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®.

New data will be unveiled from cohorts testing the de novo combination of tobevibart and elebsiran, administered every four weeks, and tobevibart monotherapy, administered every two weeks. Additional data from these cohorts, specifically the 24-week treatment outcomes, are anticipated in the fourth quarter of 2024.

Tobevibart (VIR-3434) is a subcutaneously administered antibody designed to block the entry of hepatitis B and hepatitis delta viruses into liver cells. It also aims to reduce the presence of virions and subviral particles in the bloodstream. Engineered with Xencor’s Xtend™ and other Fc technologies, tobevibart has the potential to function as a T cell vaccine against hepatitis B and hepatitis delta viruses, while possessing an extended half-life. It was discovered using Vir’s proprietary monoclonal antibody discovery platform.

Elebsiran (VIR-2218) is another investigational treatment, which targets the hepatitis B virus using a small interfering ribonucleic acid (siRNA) mechanism. This subcutaneously administered treatment is believed to stimulate an effective immune response and exhibit direct antiviral activity against both hepatitis B and hepatitis delta viruses. Notably, it is the first siRNA in clinical trials to include Enhanced Stabilization Chemistry Plus (ESC+) technology, enhancing its stability and minimizing off-target activity, which could potentially increase its therapeutic index. Elebsiran is the first asset from Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

Vir Biotechnology, Inc. is dedicated to leveraging the immune system to treat and prevent infectious diseases and other serious conditions. The company has developed two technology platforms aimed at modulating the immune system by harnessing key insights into natural immune processes. Their current clinical development pipeline includes product candidates for hepatitis delta, hepatitis B, and human immunodeficiency viruses. Additionally, Vir has several preclinical candidates targeting influenza A and B, COVID-19, RSV/MPV, and HPV.

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