Vir Biotechnology Updates on Hepatitis Delta and B Programs at AASLD 2024

1 November 2024
Vir Biotechnology, Inc., a clinical-stage biopharmaceutical company, has announced the presentation of new data from their Phase 2 SOLSTICE clinical trial, which investigates the safety and efficacy of tobevibart and elebsiran in treating chronic hepatitis delta. These findings will be shared at the forthcoming American Association for the Study of Liver Diseases (AASLD) Liver Meeting in San Diego, CA, from November 15-19, 2024. The company will also present five posters that delve deeper into the characterization of these therapies, the assessment and evaluation of hepatitis delta infection, and the economic implications of the disease.

The urgency for effective treatments for individuals with hepatitis delta, who are at risk of rapid disease progression to liver cirrhosis and liver cancer, is evident. Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer at Vir Biotechnology, expressed enthusiasm about the recent data and the potential to help patients with this debilitating disease. Additionally, he highlighted the importance of developing a functional cure for chronic hepatitis B, which could significantly improve the lives of affected individuals.

Vir Biotechnology's presentations at the AASLD meeting will include:

1. **Efficacy and Safety of Tobevibart (VIR-3434) Alone or Combined with Elebsiran (VIR-2218) in Chronic Hepatitis Delta Virus Infection**:
- **Session**: Hepatitis D: Natural History and Treatment
- **Date**: November 18
- **Time**: 6:15 – 6:30 p.m. PT
- **Presenter**: Tarik Asselah, M.D., Ph.D., Professor of Hepatology, Hôpital Beaujon, APHP, Clichy, France

2. **Pharmacokinetics and Safety of a Single Dose of Elebsiran (VIR-2218, siRNA) in Adults with Moderate Renal Impairment**:
- **Poster #1340**
- **Session**: Hepatitis B
- **Date**: November 15
- **Time**: 1:00 – 2:00 p.m. PT
- **Presenter**: Li Wang, Associate Director, Clinical Pharmacology, Vir Biotechnology, Inc.

3. **Dose-Dependent Effects of Neutralizing Anti-HBs Monoclonal Antibody VIR-3434 on Hepatitis B Surface Antigen Composition**:
- **Poster #1409**
- **Session**: Hepatitis B
- **Date**: November 15
- **Time**: 1:00 – 2:00 p.m. PT
- **Presenter**: Florian van Bömmel, M.D., Professor of Medicine, Leipzig University Medical Center

4. **Safety of Tobevibart (VIR-3434) and Elebsiran (VIR-2218) for Chronic Hepatitis B and Delta Treatment**:
- **Poster #1375**
- **Session**: Hepatitis B
- **Date**: November 15
- **Time**: 1:00 – 2:00 p.m. PT
- **Presenter**: Alina Jucov, M.D., Ph.D., Arensia Exploratory Medicine GmbH, Düsseldorf, Germany

5. **Review of Evidence Supporting the Use of Surrogate Endpoints and Fibroscan in Hepatitis D Infection**:
- **Poster #1174**
- **Session**: Hepatitis – Other Infections
- **Date**: November 15
- **Time**: 1:00 – 2:00 p.m. PT
- **Presenter**: Prajakta Bhounsule, Director, Health Economy and Marketing, Vir Biotechnology, Inc.

Additionally, an assessment of the economic burden among unique patient segments in an HDV-infected population will be presented:
- **Poster #3294**
- **Session**: Health Services and Public Health Research
- **Date**: November 17
- **Time**: 1:00 – 2:00 p.m. PT
- **Presenter**: Prajakta Bhounsule, Director, Health Economy and Marketing, Vir Biotechnology, Inc.

**Tobevibart (VIR-3434)** is an investigational monoclonal antibody that targets the hepatitis B surface antigen, aiming to prevent hepatitis B and delta viruses from entering liver cells and reducing the level of circulating viral particles. It was developed using Vir’s proprietary antibody discovery platform and is designed for subcutaneous administration.

**Elebsiran (VIR-2218)** is an investigational siRNA that targets hepatitis B virus RNA transcripts to limit the production of surface antigen. It shows potential for antiviral activity against both hepatitis B and delta viruses and is also administered subcutaneously. This represents the first clinical asset from Vir's collaboration with Alnylam Pharmaceuticals, Inc.

**Chronic Hepatitis Delta (CHD)** is a severe liver disease caused by the hepatitis D virus, requiring hepatitis B virus for replication. Affecting around 5% of those with chronic HBV, it leads to accelerated progression to liver cancer and liver-related death. Current treatment options are limited.

**Chronic Hepatitis B (CHB)** is a long-term inflammatory liver disease caused by HBV, affecting millions globally with significant yearly fatalities. Although treatable, there is no cure, and complications include liver cirrhosis, failure, and cancer.

Vir Biotechnology remains committed to advancing treatments for these serious conditions, with ongoing efforts to provide new therapeutic options and improve patient outcomes.

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