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Multiple Abstracts Highlighting Vir Biotechnology’s Latest Hepatitis Delta & B Data Accepted for Presentation at the EASL Congress 2024

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Vir Biotechnology announced that three abstracts focusing on chronic hepatitis delta and hepatitis B will be presented at the EASL Congress 2024 in Milan from June 5-8.

The presentations include new data from the Phase 2 SOLSTICE trial, evaluating the safety and efficacy of tobevibart and elebsiran in chronic hepatitis delta patients.

Key highlights include 12 and 24-week treatment data, as well as 48-week data for a subset of participants.

Additional 24-week data on all 60 participants will be reported in Q4 2024. An investor conference call is scheduled for June 5 to discuss these findings.

Positive
  • Three abstracts accepted for EASL Congress 2024, increasing visibility.
  • Oral presentation on Phase 2 SOLSTICE trial indicates advanced progress.
  • 48-week treatment data shows ongoing monitoring and efficacy.
  • Additional 24-week data on all participants to be reported in Q4 2024.
  • Potential for tobevibart and elebsiran to address unmet needs in chronic hepatitis delta treatment.
Negative
  • Current data to early and mid-term results (12-24 weeks).
  • Pending data for the full 60 participants delays comprehensive assessment until Q4 2024.
  • No conclusive long-term efficacy and safety data yet available.
  • Potential investor uncertainty due to ongoing trial status.

– Company to present important new data from the Phase 2 SOLSTICE chronic hepatitis delta trial –

– Conference call scheduled for June 5, 2024, at 6:00 a.m. ET / 12:00 p.m. CEST –

SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that three abstracts highlighting new data from the Company’s chronic hepatitis delta and chronic hepatitis B programs have been accepted for presentation at the annual meeting of the European Association for the Study of the Liver, EASL™ Congress 2024, taking place in Milan, Italy from June 5-8. This includes an oral presentation on June 8, which was originally accepted as a late-breaker poster, that will highlight the Company’s latest Phase 2 SOLSTICE trial data. The Company also plans to host an investor conference call on June 5 at 6:00 a.m. ET / 12:00 p.m. CEST to discuss the data.

The SOLSTICE trial (NCT05461170) is evaluating the safety, tolerability and efficacy of tobevibart and elebsiran for the treatment of people living with chronic hepatitis delta. The oral presentation will include data on participants who have reached 12 and 24 weeks of chronic suppressive treatment. The Company will also share 48-week treatment data on the efficacy and safety of tobevibart and elebsiran for the six participants that were previously reported on at the 2023 American Association for the Study of Liver Diseases (AASLD) The Liver Meeting®. The Company is on track to report additional 24-week treatment data on all the approximately 60 SOLSTICE participants in the fourth quarter of 2024.

“Vir remains steadfast in its mission to develop a transformative chronic suppressive therapy for the estimated 12 million or more people living with chronic hepatitis delta. The accepted abstracts highlight the remarkable progress we have made and the potential for tobevibart and elebsiran to make a significant impact in addressing this critical unmet need,” said Carey Hwang, M.D., Ph.D., Vir’s Senior Vice President, Clinical Research and Interim Chief Medical Officer. “We look forward to sharing new data which will offer further insights into virologic response rates, ALT normalization, and durability of viral suppression.”

Presentation details are as follows:

Oral Presentation

  • Title: Efficacy and safety of tobevibart (VIR-3434) alone or in combination with elebsiran (VIR-2218) in participants with chronic hepatitis delta virus infection: preliminary results from the phase 2 SOLSTICE trial in non-cirrhotic and compensated cirrhotic participants (OS-127)
    Session: Viral hepatitis B/D: Therapy
    Date: Saturday, June 8
    Time: 11:45 a.m. CEST (5:45 a.m. EDT)
    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

  • Title: Tobevibart (VIR-3434), a monoclonal antibody, resistance analysis in participants with chronic HBV: Results from a Phase 1 single dose study (WED-376)
    Session: Poster - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies
    Date: Wednesday, June 5
    Time: Available from 8:30 a.m. CEST (2:30 a.m. EDT)
    Presenter: Andrea Cathcart, Ph.D., Senior Director, Clinical Virology, Vir Biotechnology
  • Title: Pharmacokinetics and safety of the monoclonal antibody tobevibart (VIR-3434) administered as monotherapy or in combination with the small interfering RNA elebsiran (VIR-2218) in cirrhotic participants with mild hepatic impairment (WED-389)
    Session: Poster - Viral Hepatitis B and D: New therapies, unapproved therapies or strategies
    Date: Wednesday, June 5
    Time: Available from 8:30 a.m. CEST (2:30 a.m. EDT)
    Presenter: Sneha V. Gupta, Ph.D., Director, Clinical Pharmacology, Vir Biotechnology

A live webcast of the investor conference call will be made available on https://investors.vir.bio and will be archived there for 30 days.

About Tobevibart

Tobevibart is an investigational subcutaneously administered antibody designed to block entry of hepatitis B and hepatitis delta viruses into hepatocytes and to reduce the level of virions and subviral particles in the blood. Tobevibart, which incorporates Xencor’s Xtend™ and other Fc technologies, has been engineered to potentially function as a T cell vaccine against hepatitis B virus and hepatitis delta virus, as well as to have an extended half-life. Tobevibart was identified using Vir’s proprietary monoclonal antibody discovery platform.

About Elebsiran

Elebsiran is an investigational subcutaneously administered hepatitis B virus-targeting small interfering ribonucleic acid (siRNA) that Vir believes has the potential to stimulate an effective immune response and have direct antiviral activity against hepatitis B virus and hepatitis delta virus. It is the first siRNA in the clinic to include Enhanced Stabilization Chemistry Plus (ESC+) technology to enhance stability and minimize off-target activity, which potentially could result in an increased therapeutic index. Elebsiran is the first asset in the Company’s collaboration with Alnylam Pharmaceuticals, Inc. to enter clinical trials.

About Vir Biotechnology, Inc.

Vir Biotechnology, Inc. is an immunology company focused on powering the immune system to transform lives by treating and preventing infectious diseases and other serious conditions, including viral-associated diseases. Vir has assembled two technology platforms that are designed to modulate the immune system by exploiting critical observations of natural immune processes. Its current clinical development pipeline consists of product candidates targeting hepatitis delta and hepatitis B viruses, and human immunodeficiency virus. Vir has several preclinical candidates in its pipeline, including those targeting influenza A and B, COVID-19, RSV/MPV and HPV. 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, 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.

Media

Carly Scaduto

Senior Director, External Communications

cscaduto@vir.bio

+1 314-368-5189

Investors

Richard Lepke

Senior Director, Investor Relations

rlepke@vir.bio

+1 978-973-9986

Source: Vir Biotechnology, Inc.

FAQ

What new data will Vir Biotechnology present at the EASL Congress 2024?

Vir Biotechnology will present data from its Phase 2 SOLSTICE trial on chronic hepatitis delta, including 12 and 24-week treatment data and 48-week data for a subset of participants.

When is Vir Biotechnology's investor conference call to discuss the EASL 2024 data?

The investor conference call is scheduled for June 5, 2024, at 6:00 a.m. ET / 12:00 p.m. CEST.

What is the focus of the Phase 2 SOLSTICE trial?

The Phase 2 SOLSTICE trial is focused on evaluating the safety, tolerability, and efficacy of tobevibart and elebsiran in treating chronic hepatitis delta.

When will additional data from the SOLSTICE trial be available?

Additional 24-week treatment data on all 60 SOLSTICE participants will be reported in the fourth quarter of 2024.

What are the key highlights of Vir Biotechnology's oral presentation at EASL 2024?

The oral presentation will highlight the efficacy and safety of tobevibart and elebsiran in chronic hepatitis delta patients based on 12 and 24-week data.

Vir Biotechnology, Inc.

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