– Approximately 3,000 participants enrolled with initial trial data expected in mid-2023 –
SAN FRANCISCO, Dec. 21, 2022 (GLOBE NEWSWIRE) -- Vir Biotechnology, Inc. (Nasdaq: VIR) today announced it has achieved the target enrollment of approximately 3,000 participants in the groundbreaking Phase 2 PENINSULA (PrevEntioN of IllNesS DUe to InfLuenza A) trial evaluating VIR-2482 for the prevention of illness due to influenza A. PENINSULA is the first Phase 2 outpatient trial to evaluate the role of a monoclonal antibody in the prevention of influenza A illness. The first participant was dosed in October 2022 and initial trial data are expected in mid-2023.
“We are experiencing the worst flu season in more than a decade, with at least 150,000 hospitalizations and 9,300 deaths from flu reported in the U.S. alone so far. These numbers emphasize the urgent need for additional preventive approaches against seasonal flu, especially for those at highest risk of hospitalization,” said Phil Pang, M.D., Ph.D., executive vice president, chief medical officer and interim head of research at Vir Biotechnology. “The rapid enrollment of the PENINSULA trial is a significant milestone that brings us one step closer to addressing the critical gap in preventing flu illness among those at high risk of serious illness. We look forward to reviewing the initial data to better understand whether a single shot of VIR-2482 has the potential to provide protection for the entire flu season.”
VIR-2482 is an intramuscularly administered investigational monoclonal antibody that has demonstrated in vitro the ability to neutralize all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. Designed to be a prophylactic against both seasonal and pandemic influenza A, VIR-2482 has been engineered to have an extended half-life, providing the potential for protection throughout an entire flu season.
Design of the Phase 2 PENINSULA Trial
The multi-center, double-blind, randomized, placebo-controlled Phase 2 PENINSULA trial (ClinicalTrials.gov Identifier: NCT05567783) is evaluating the efficacy, safety and tolerability of two different doses of VIR-2482 in preventing influenza A illness in healthy adults. The dose-ranging, proof-of-concept trial enrolled approximately 3,000 men and women ages 18 to 64 without risk factors for serious complications from an influenza infection who have not received an influenza vaccination for the current season.
The primary efficacy endpoint is the proportion of trial participants with protocol-defined influenza-like illness with confirmed influenza A infection compared to placebo. Other endpoints will evaluate the effect of VIR-2482 on the severity and duration of illness in trial participants with confirmed influenza A compared to placebo.
The Company also recently fully enrolled a Phase 1b prophylaxis trial evaluating the safety of VIR-2482 in elderly participants (age 65 and older) receiving a flu vaccine. This population is representative of the Company’s anticipated Phase 3 trial population. Initial data from the Phase 1b prophylaxis trial are expected in mid-2023.
About Seasonal and Pandemic Influenza A
Seasonal influenza is a highly contagious respiratory disease that can cause severe illness and life-threatening complications. It varies from season to season, but in past years has led to approximately 4 million hospitalizations and about 500,000 deaths a year worldwide. There remains a significant unmet need to address the shortcomings of current preventive and therapeutic options, which provide annual efficacy ranging from 10%-40% among patients >65 years.
Pandemic influenza is a contagious airborne respiratory disease that is unpredictable in timing and severity and for which humans have little or no immunity. Four influenza pandemics have occurred over the past century, with the most severe being the 1918 Spanish flu, which is estimated to have caused at least 50 million deaths worldwide.
VIR-2482 is an investigational intramuscularly administered influenza A-neutralizing monoclonal antibody. In vitro, it has been shown to cover all major strains of influenza A that have arisen since the 1918 Spanish flu pandemic. VIR-2482 is designed as a prophylactic for influenza A. It has the potential to address the limitations of current flu vaccines and lead to meaningfully higher levels of protection due to its broad strain coverage and because it does not rely on an individual to create their own protective antibody response. VIR-2482, which incorporates Xencor’s Xtend™ technology, also has been half-life engineered so that a single dose has the potential to last the entire flu season. Under the collaboration agreement signed with GSK in 2021, GSK has an exclusive option to lead post-Phase 2 development and commercialization of VIR-2482.
The development of VIR-2482 has been supported in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response (ASPR); Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Number: 75A50122C00081.
About Vir Biotechnology
Vir Biotechnology is a commercial-stage immunology company focused on combining immunologic insights with cutting-edge technologies to treat and prevent serious infectious diseases. Vir has assembled four technology platforms that are designed to stimulate and enhance the immune system by exploiting critical observations of natural immune processes. The Company’s current development pipeline consists of product candidates targeting COVID-19, hepatitis B and hepatitis D viruses, influenza A and human immunodeficiency virus. Vir routinely posts information that may be important to investors on its website.
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 benefits of VIR-2482 to protect against seasonal and pandemic influenza, the timing and design of VIR-2482’s Phase 2 PENINSULA trial and Phase 1b prophylaxis trial, including anticipated timing of data readouts, statements regarding Vir’s scientific and executional expertise, and risks and uncertainties associated with drug development and commercialization. Many factors may cause differences between current expectations and actual results, including risks of unexpected safety or efficacy data or results observed during the Phase 2 PENINSULA trial or Phase 1b prophylaxis trial 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 the COVID-19 pandemic, 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.
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