Vir Biotechnology Advances Hepatitis Delta and B Programs with New Clinical Data
Key Insights
Vir Biotechnology is set to present Phase 2 SOLSTICE trial data of tobevibart and elebsiran for chronic hepatitis delta (search) at AASLD.
The SOLSTICE trial's week 24 primary endpoint analysis will be shared, along with insights into hepatitis delta (search)'s economic impact.
Tobevibart, a monoclonal antibody, and elebsiran, a siRNA, target hepatitis B surface antigen to inhibit viral entry and replication.
Vir Biotechnology, Inc. (NASDAQ: VIR) is set to present new data from its chronic hepatitis programs at the upcoming American Association for the Study of Liver Diseases (AASLD) The Liver Meeting in San Diego, CA, November 15-19, 2024. The company will share findings from the Phase 2 SOLSTICE clinical trial evaluating tobevibart, an investigational monoclonal antibody (mAb), and elebsiran, an investigational small interfering ribonucleic acid (siRNA), for the potential treatment of chronic hepatitis delta (search).
The data includes the week 24 primary endpoint analysis from the SOLSTICE trial. In addition to the oral presentation, Vir Biotechnology will present five poster presentations. These posters will further characterize the investigational therapies and recent efforts to improve the assessment and evaluation of hepatitis delta (search) infection, along with insights into the economic burden for patients and society. Advances from across the chronic hepatitis B (search) development program will also be shared.
Urgent Need for Effective Therapies
Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer at Vir Biotechnology, emphasized the importance of these findings, stating, "There is an urgent need for effective therapies for people living with hepatitis delta (search) who can face rapid progression to liver cirrhosis (search) and liver cancer (search). We are excited by the latest data from our hepatitis delta development program, and we look forward to sharing our latest findings at AASLD as we work to help patients living with this debilitating condition."
Tobevibart and Elebsiran: Novel Therapeutic Approaches
Tobevibart (VIR-3434) is an investigational broadly neutralizing monoclonal antibody that targets the hepatitis B surface antigen. It is designed to inhibit the entry of both hepatitis B (search) and hepatitis delta (search) viruses into hepatocytes and reduce the level of circulating viral and subviral particles in the blood. The antibody has been engineered for an extended half-life and optimized binding to immune cells and is administered subcutaneously.
Elebsiran (VIR-2218) is an investigational hepatitis B (search) virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. It is administered subcutaneously and is currently in clinical development for the treatment of patients with chronic hepatitis B and hepatitis delta (search). Elebsiran is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies.
Disease Burden and Current Treatment Landscape
Chronic hepatitis delta (search) (CHD) is a long-lasting, inflammatory liver disease caused by the hepatitis D virus (HDV), which requires the presence of hepatitis B (search) virus (HBV) for its replication. CHD affects nearly 5% of people who have a chronic infection with HBV and is considered by the World Health Organization to be the most severe form of chronic viral hepatitis. Co-infection with HDV accelerates progression towards liver cancer (search) and liver-related death by almost a decade in comparison to HBV mono-infected persons, independently of their age. Currently, there is no cure, and treatment options are limited.
Chronic hepatitis B (search) (CHB) is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV). The World Health Organization estimates that 254 million people were living with CHB infection in 2022, with 1.2 million new infections each year, and an estimated 1.1 million yearly deaths associated to the disease. Complications from CHB may include liver cirrhosis (search), liver failure, and liver cancer (search). Although CHB can be treated, there is no cure available today.
Presentation Details
Vir Biotechnology will present the efficacy and safety of tobevibart alone or in combination with elebsiran in participants with chronic hepatitis delta (search) virus infection, including the week 24 primary endpoint analysis from the Phase 2 SOLSTICE trial. The oral presentation is scheduled for Monday, November 18, from 6:15 - 6:30 p.m. PT. Presenter: Tarik Asselah, M.D., Ph.D., Professor of Hepatology at the Hôpital Beaujon, APHP, Clichy, France, and at the University of Paris, and Head of Viral Hepatitis at INSERM UMR1149, France.
Poster presentations include:
- Pharmacokinetics and safety of a single dose of elebsiran (VIR-2218, siRNA) subcutaneously administered in adult participants with moderate renal impairment (Poster #1340)
- Dose-Dependent Effects of Neutralizing Anti-HBs Monoclonal Antibody VIR-3434 on Hepatitis B Surface Antigen Composition (Poster #1409)
- Safety Profile of tobevibart (VIR-3434) and elebsiran (VIR-2218) for the treatment of chronic hepatitis B and delta (CHB and CHD) (Poster #1375)
- Review of evidence to support the use of surrogate endpoints and fibroscan in hepatitis D infection (Poster #1174)
- Assessing economic burden among unique patient segments in an HDV-infected population (Poster #3294)