Vir Biotechnology Announces Clinical Advances Across Hepatitis Delta and Hepatitis B Programs at AASLD’s The Liver Meeting® 2024

Rhea-AI Summary

Vir Biotechnology (NASDAQ:VIR) announced it will present new data from the Phase 2 SOLSTICE clinical trial evaluating tobevibart and elebsiran for the potential treatment of chronic hepatitis delta at AASLD's The Liver Meeting® 2024. The company will present an oral presentation on the Week 24 primary endpoint analysis of the SOLSTICE trial, along with five poster presentations.

The posters will cover topics including:

• Pharmacokinetics and safety of elebsiran in participants with moderate renal impairment
• Dose-dependent effects of tobevibart on Hepatitis B Surface Antigen composition
• Safety profile of tobevibart and elebsiran for chronic hepatitis B and delta
• Evidence supporting surrogate endpoints and fibroscan in hepatitis D infection
• Economic burden among HDV-infected patient segments

These presentations aim to highlight progress in Vir's hepatitis delta and hepatitis B clinical programs, as well as provide insights into disease burden.

Positive

• Phase 2 SOLSTICE trial data for hepatitis delta treatment to be presented
• Multiple presentations showcasing progress in hepatitis B and D programs
• Potential for tobevibart and elebsiran to address unmet needs in hepatitis delta treatment

Negative

• None.

Insights

Medical Research Analyst

The presentation of Phase 2 SOLSTICE trial data for tobevibart and elebsiran in hepatitis delta is a significant development. These investigational therapies target a severe form of viral hepatitis with treatment options. The 24-week efficacy and safety data will provide important insights into their potential as a new treatment paradigm.

Key points to consider:

• Hepatitis delta often leads to rapid liver disease progression, highlighting the urgent need for effective therapies
• The combination approach of a monoclonal antibody (tobevibart) with siRNA (elebsiran) represents an innovative treatment strategy
• Safety data across hepatitis B and delta programs will be important for assessing the overall risk-benefit profile
• Pharmacokinetic data in patients with renal impairment expands understanding of elebsiran's clinical utility

While promising, investors should note that this is still mid-stage data. The path to potential approval and commercialization remains long, with pivotal trials likely needed. However, positive results could significantly boost Vir's pipeline value in liver diseases.

Financial Analyst

This news highlights Vir Biotechnology's progress in developing treatments for hepatitis delta and hepatitis B, potentially expanding their market opportunities in liver diseases. Key financial implications include:

• Advancing multiple candidates (tobevibart and elebsiran) could diversify risk and increase chances of market success
• Targeting hepatitis delta, a severe form with treatments, could command premium pricing if approved
• Data on economic burden of hepatitis delta may support future pricing and reimbursement strategies
• Multiple presentations at a major liver conference increase visibility and could attract potential partners or investors

However, as a clinical-stage biotech with a $1.04 billion market cap, Vir remains speculative. The company had $1.8 billion in cash as of Q2 2023, providing runway for continued development. Positive data could drive stock momentum, but investors should be aware of the inherent risks in drug development. The focus on both efficacy and safety data is important for long-term commercial potential.

– Phase 2 SOLSTICE Safety and Efficacy Data in Hepatitis Delta Trial at Week 24 to Be Presented –

– Oral and Five Poster Presentations Highlight Important Progress in Hepatitis Delta and Hepatitis B Clinical Programs, and Deliver Key Insights on the Burden of Disease Among Patient Segments in Hepatitis Delta –

SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (NASDAQ:VIR) today announced it will present new data from the Phase 2 SOLSTICE clinical trial evaluating the efficacy and safety profile of tobevibart, an investigational monoclonal antibody (mAb), and elebsiran, an investigational small interfering ribonucleic acid (siRNA) for the potential treatment of chronic hepatitis delta.

These data will be presented in an oral presentation at the upcoming American Association for the Study of Liver Diseases (AASLD) The Liver Meeting^®, in San Diego, CA, November 15-19, 2024. Vir will also present five poster presentations that further characterize these investigational therapies as well as recent efforts to improve the assessment and evaluation of hepatitis delta infection, and insights into the economic burden of hepatitis delta for patients and society. Vir will also share advances from across the chronic hepatitis B development program.

“There is an urgent need for effective therapies for people living with hepatitis delta who can face rapid progression to liver cirrhosis and liver cancer. 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,” said Mark Eisner, M.D., M.P.H., Executive Vice President and Chief Medical Officer, Vir Biotechnology. “Further, patients living with chronic hepatitis B face lifelong treatment and an increased risk of cirrhosis and liver cancer, so developing a functional cure could transform their lives. We are pleased to share data further characterizing our investigational therapies as we continue on our mission to advance a functional cure.”

Vir will be presenting the following abstracts:

• Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: Week 24 primary endpoint analysis from the Phase 2 SOLSTICE trial
  Session: Hepatitis D: Natural History and Treatment
  Date: Monday, November 18
  Time: 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

• Pharmacokinetics and safety of a single dose of elebsiran (VIR-2218, siRNA) subcutaneously administered in adult participants 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.

• 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, Division of Hepatology, Department of Medicine II, Leipzig University Medical Center.

• Safety Profile of tobevibart (VIR-3434) and elebsiran (VIR-2218) for the treatment of chronic hepatitis B and delta (CHB and CHD) (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, and Nicolae Testemitanu, State University of Medicine and Pharmacy, Chişinău, Moldova.

• Review of evidence to support 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.

• Assessing economic burden among unique patient segments in an HDV-infected population (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.

About Tobevibart (VIR-3434)

Tobevibart is an investigational broadly neutralizing monoclonal antibody targeting the hepatitis B surface antigen. It is designed to inhibit the entry of hepatitis B and hepatitis delta viruses into hepatocytes, and to reduce the level of circulating viral and subviral particles in the blood. Tobevibart was identified using Vir’s proprietary antibody discovery platform and has been engineered to have an extended half-life and optimized binding to immune cells. Tobevibart is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta.

About Elebsiran (VIR-2218)

Elebsiran is an investigational hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) designed to degrade hepatitis B virus RNA transcripts and limit the production of hepatitis B surface antigen. Current data indicates that it has the potential to have direct antiviral activity against hepatitis B virus and hepatitis delta virus. Elebsiran is administered subcutaneously, and it is currently in clinical development for treatment of patients with chronic hepatitis B and patients with chronic hepatitis delta. It is the first asset in Vir’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical studies.

About Chronic Hepatitis Delta

Chronic hepatitis delta (CHD) is a long-lasting, inflammatory liver disease caused by the hepatitis D virus (HDV), which requires the presence of hepatitis B virus (HBV) for its replication¹. CHD affects nearly 5% of people who have a chronic infection with HBV, and it is considered by the World Health Organization to be the most severe form of chronic viral hepatitis². Co-infection with HDV accelerates progression towards liver cancer and liver-related death by almost a decade in comparison to HBV mono-infected persons, independently of their age³. There is no cure, and treatment options are limited.

References:

¹ NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis D - NIDDK (nih.gov), accessed September 2024.
² WHO Hepatitis Delta Factsheet - Hepatitis D (who.int), accessed September 2024
³ CDC https://www.cdc.gov/hepatitis/hdv/hdvfaq.htm

About Chronic Hepatitis B

Chronic hepatitis B (CHB) a is a long-lasting, inflammatory liver disease caused by the hepatitis B virus (HBV)¹. 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 disease². Complications from CHB may include liver cirrhosis, liver failure and liver cancer³. Although CHB can be treated, there’s no cure available today¹.

References:

¹ CDC Hepatitis B Basics | Hepatitis B | CDC
² WHO Hepatitis B Factsheet - Hepatitis B (who.int), accessed September 2024
³ NIH National Institute of Diabetes and Digestive and Kidney Diseases Hepatitis B - NIDDK (nih.gov), accessed September 2024.

About Vir Biotechnology, Inc.

Vir Biotechnology, Inc. is a clinical-stage biopharmaceutical company focused on powering the immune system to transform lives by discovering and developing medicines for serious infectious diseases and cancer. Vir’s clinical-stage portfolio includes infectious disease programs for chronic hepatitis delta and chronic hepatitis B infections, in addition to multiple oncology programs. Vir also has a preclinical portfolio of programs across a range of other infectious diseases and oncologic malignancies. Vir routinely posts information that may be important to investors on its website.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “plan,” “potential,” “aim,” “expect,” “anticipate,” “promising” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Vir’s expectations and assumptions as of the date of this press release. Forward-looking statements contained in this press release include, but are not limited to, statements regarding Vir’s strategy and plans, the potential clinical effects of tobevibart and elebsiran, the potential benefits, safety and efficacy of tobevibart and elebsiran, the timing, nature and significance of data from Vir’s multiple ongoing trials evaluating tobevibart and elebsiran, Vir’s plans and expectations for its CHD and CHB programs, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including unexpected safety or efficacy data or results observed during clinical trials or in data readouts; the occurrence of adverse safety events; risks of unexpected costs, delays or other unexpected hurdles; difficulties in collaborating with other companies; successful development and/or commercialization of alternative product candidates by Vir’s competitors; changes in expected or existing competition; delays in or disruptions to Vir’s business or clinical trials due to geopolitical changes or other external factors; and unexpected litigation or other disputes. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You should not place undue reliance on these statements, or the scientific data presented. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Vir’s filings with the U.S. Securities and Exchange Commission, including the section titled “Risk Factors” contained therein. Except as required by law, Vir assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

View source version on businesswire.com: https://www.businesswire.com/news/home/20241014730787/en/

Media

Arran Attridge

Senior Vice President, Corporate Communications

aattridge@vir.bio

Investors

Richard Lepke

Senior Director, Investor Relations

rlepke@vir.bio

Source: Vir Biotechnology, Inc.

FAQ

What data will Vir Biotechnology (VIR) present at AASLD's The Liver Meeting 2024?

Vir Biotechnology will present new data from the Phase 2 SOLSTICE clinical trial evaluating tobevibart and elebsiran for chronic hepatitis delta treatment, including Week 24 primary endpoint analysis. They will also present five posters on various aspects of their hepatitis B and D programs.

What are the investigational therapies Vir Biotechnology (VIR) is developing for hepatitis delta?

Vir Biotechnology is developing tobevibart, an investigational monoclonal antibody (mAb), and elebsiran, an investigational small interfering ribonucleic acid (siRNA), for the potential treatment of chronic hepatitis delta.

When and where will Vir Biotechnology (VIR) present its hepatitis delta data?

Vir Biotechnology will present its hepatitis delta data at the American Association for the Study of Liver Diseases (AASLD) The Liver Meeting® in San Diego, CA, from November 15-19, 2024.

What topics will Vir Biotechnology's (VIR) poster presentations cover at AASLD 2024?

Vir's poster presentations will cover pharmacokinetics and safety of elebsiran, dose-dependent effects of tobevibart, safety profiles of both drugs, evidence for surrogate endpoints in hepatitis D, and the economic burden of hepatitis delta virus infection.