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Vir Biotechnology Receives FDA IND Clearance and Fast Track Designation for Tobevibart and Elebsiran for the Treatment of Chronic Hepatitis Delta Infection

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Vir Biotechnology (Nasdaq: VIR) has received FDA clearance for its IND application and Fast Track designation for its combination treatment of tobevibart and elebsiran aimed at chronic hepatitis delta infection. The IND clearance follows positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024. The Phase 2 SOLSTICE trial data showed high rates of virologic response and ALT normalization at 12 and 24 weeks, with complete 24-week data expected in Q4. This Fast Track designation will facilitate the expedited review and development of this promising treatment. Hepatitis delta, considered the most severe form of chronic viral hepatitis by the WHO, affects over 12 million people globally. Vir plans to initiate its ECLIPSE trial soon, which will support potential registration of the treatment.

Positive
  • FDA IND clearance and Fast Track designation for tobevibart and elebsiran.
  • Positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024.
  • High rates of virologic response and ALT normalization at 12 and 24 weeks in the Phase 2 SOLSTICE trial.
  • Complete 24-week treatment data expected in Q4 2024.
  • ECLIPSE trial initiation to support potential registration of the treatment.
Negative
  • None.

The FDA's Fast Track designation for tobevibart and elebsiran, combined with the IND clearance, is a significant milestone for Vir Biotechnology. Fast Track status is a clear indication that the FDA recognizes the potential of this treatment to address a serious and unmet medical need. Chronic hepatitis delta is particularly severe, often leading to rapid progression to liver cancer and liver-related deaths. This status not only expedites the development process but also facilitates greater interaction with the FDA, potentially accelerating access to new treatments for patients in need.

From a clinical perspective, it's noteworthy that the combination treatment has demonstrated promising results in the preliminary Phase 2 SOLSTICE trial. High rates of virologic response and ALT normalization are strong indicators of efficacy and the fact that the treatment was generally well tolerated further supports its potential. As the complete 24-week treatment data becomes available, it will be important to monitor consistency and durability of these results.

The upcoming ECLIPSE trial, intended to support potential registration, will be pivotal. Success in this trial could pave the way for regulatory approval and commercialization, making the treatment accessible to a broader patient population. The open-label, randomized, controlled design will provide robust evidence of safety and efficacy, enhancing the credibility of the results.

From a financial standpoint, the FDA's IND clearance and Fast Track designation are highly positive developments for Vir Biotechnology. Such regulatory milestones often translate into increased investor confidence, potentially driving up the company’s stock price. Additionally, the Fast Track designation can lead to shorter review times and potentially earlier market entry, which may accelerate revenue generation from this new treatment.

Investors should pay attention to the upcoming release of the complete 24-week treatment data from the Phase 2 SOLSTICE trial. Positive results could further boost the stock, attracting more investment and enabling the company to secure additional funding if needed. However, the financial community will also be vigilant for any adverse results or safety concerns that could arise.

In the broader context, the estimated global patient population of 12 million individuals living with chronic hepatitis delta presents a substantial market opportunity. If tobevibart and elebsiran prove to be effective and receive regulatory approval, they could capture significant market share, leading to substantial revenue growth for Vir Biotechnology. However, investors should also consider the competitive landscape and potential challenges in market penetration.

The market implications of Vir Biotechnology’s recent achievements are profound. The FDA’s Fast Track designation is a clear response to the significant unmet medical need for effective treatments for chronic hepatitis delta. The competitive landscape in the biopharmaceutical industry for antiviral treatments is fierce, but a successful treatment for such a severe condition could position Vir Biotechnology as a leader in this niche market.

The preliminary Phase 2 data showing high rates of virologic response and ALT normalization is promising. However, it is essential to wait for the complete 24-week data to better understand the longevity and robustness of these results. The fact that the treatment was well tolerated adds a competitive edge, given that safety profiles are critical in patient and physician adoption of new therapies.

The ECLIPSE trial will serve as a critical juncture. A well-executed trial with favorable outcomes could not only lead to regulatory approval but also set the stage for strong market uptake. Market strategies post-approval will need to focus on educating healthcare providers about the benefits and efficacy of the new treatment to drive adoption quickly.

Fast Track designation follows positive preliminary Phase 2 trial data presented at the European Association for the Study of the Liver Congress 2024 and underscores the unmet need for people living with chronic hepatitis delta

SAN FRANCISCO--(BUSINESS WIRE)-- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced that the U.S. Food and Drug Administration (FDA) has cleared its investigational new drug (IND) application and granted Fast Track designation for the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection. Tobevibart, an investigational monoclonal antibody, and elebsiran, an investigational small interfering ribonucleic acid, are currently being evaluated in the Company’s Phase 2 SOLSTICE hepatitis delta clinical trial, with complete 24-week treatment data on track to be reported in the fourth quarter.

“The IND clearance and Fast Track designation from the FDA, along with the encouraging preliminary data from our Phase 2 hepatitis delta trial, underscore the potential of tobevibart and elebsiran to transform the treatment landscape for people living with this severe and life-threatening disease,” said Marianne De Backer, M.Sc., Ph.D., MBA, Vir’s Chief Executive Officer. “We are committed to working closely with health authorities to bring this potential groundbreaking treatment to patients as quickly as possible, addressing a critical unmet medical need.”

The FDA’s Fast Track designation is intended to facilitate the development and expedite the review of drugs to treat serious conditions and fill an unmet medical need. The World Health Organization considers hepatitis delta to be the most severe form of chronic viral hepatitis due to more rapid progression towards liver cancer and liver-related death. It is estimated that at least 12 million people are living with chronic hepatitis delta globally.

In June, the Company announced preliminary Phase 2 SOLSTICE trial data which suggests treatment with tobevibart alone or in combination with elebsiran was generally well tolerated and participants achieved high rates of virologic response at weeks 12 and 24, durable virologic response through 48 weeks, and high rates of ALT normalization. The complete 24-week treatment data is expected in the fourth quarter. The Company is working to expedite the initiation of its next study, the ECLIPSE trial. The open-label, randomized, controlled ECLIPSE trial is designed to support potential registration and will evaluate the safety and efficacy of a monthly-administered subcutaneous injection of tobevibart and elebsiran using the current standard of care therapy as a comparator.

About the Phase 2 SOLSTICE Trial

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. One cohort is evaluating the combination of tobevibart and elebsiran dosed every 4 weeks with a second cohort evaluating tobevibart monotherapy every 2 weeks. Approximately 50% of participants have compensated cirrhosis.

About Tobevibart (VIR-3434)

Tobevibart is an investigational subcutaneously administered antibody designed to inhibit entry of hepatitis B and hepatitis delta viruses into hepatocytes, neutralize both hepatitis B virus and hepatitis delta virus virions, 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 have an extended half-life and was identified using Vir’s proprietary monoclonal antibody discovery platform.

About Elebsiran (VIR-2218)

Elebsiran is an investigational subcutaneously administered 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. Vir believes it has the potential to 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, the ability of tobevibart and elebsiran (as monotherapies or combination therapies) to treat and/or prevent chronic hepatitis Delta (CHD) or chronic hepatitis B virus (CHB), Vir’s plans and expectations for its CHD and CHB programs, the timing and outcome of Vir’s planned interactions with the FDA, Vir’s ability to realize the benefits from receiving the Fast Track designation from the FDA, whether Vir maintains Fast Track designation and/or receives any additional accelerated development paths from the FDA for tobevibart and elebsiran (as monotherapies or combination therapies) to treat and/or prevent CHD or CHB, timing and enrollment for Vir’s ECLIPSE trial, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including that receiving Fast Track designation might not result in a more expedited development or regulatory review process, and such a designation does not increase the likelihood that the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection will receive marketing approval in the United States; the Fast Track designation does not change the standards for regulatory approval; the FDA may later decide that the combination of tobevibart and elebsiran for the treatment of chronic hepatitis delta infection no longer meets the conditions for qualification or that the time period for FDA review or approval will not be shortened; 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 is the recent FDA designation for Vir Biotechnology (VIR)?

Vir Biotechnology received FDA IND clearance and Fast Track designation for its combination treatment of tobevibart and elebsiran for chronic hepatitis delta infection.

What are tobevibart and elebsiran?

Tobevibart is an investigational monoclonal antibody, and elebsiran is an investigational small interfering ribonucleic acid, both evaluated for treating chronic hepatitis delta infection.

What were the results of the Phase 2 SOLSTICE trial for Vir Biotechnology?

The preliminary Phase 2 SOLSTICE trial data showed high rates of virologic response and ALT normalization at 12 and 24 weeks.

When will the complete 24-week treatment data be available?

The complete 24-week treatment data is expected in the fourth quarter of 2024.

What is the purpose of the ECLIPSE trial for Vir Biotechnology (VIR)?

The ECLIPSE trial is designed to evaluate the safety and efficacy of a monthly-administered injection of tobevibart and elebsiran and will support potential registration of the treatment.

Why is the Fast Track designation significant for Vir Biotechnology's treatment?

The Fast Track designation facilitates the development and expedited review of drugs to treat serious conditions and fill an unmet medical need, potentially bringing the treatment to patients faster.

Vir Biotechnology, Inc.

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