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Vir Biotech, Glaxo Begin Phase III Study on Coronavirus Therapy
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Vir Biotechnology, Inc. (VIR - Free Report) along with its partner GlaxoSmithKline (GSK - Free Report) announced that they are expanding their COMET-ICE study to phase III. The study is evaluating their monoclonal antibody candidate VIR-7831 for the early treatment of COVID-19 in patients who are at a high risk of hospitalization. Patient enrollment is currently underway in the above-mentioned study.
The companies decided to enter into phase III testing, the most crucial phase of evaluation of any drug/candidate following a positive assessment of safety and tolerability data from the lead in portion of the phase II COMET-ICE study by an Independent Data Monitoring Committee. The registrational study will now expand worldwide to additional sites in North America, South America and Europe.
VIR-7831 (also known as GSK4182136) entered into phase II/III evaluation in August 2020.
The phase III portion of the study will evaluate the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants. Initial data from the same is expected by 2020-end while complete results (primary endpoint) are expected in the first quarter of 2021. If successfully developed, VIR-7831 has the potential to advance outpatient treatment for COVID-19.
Shares of Vir Biotechnology were up 6.1% following the above announcement on Tuesday. In fact, the stock has skyrocketed 230% so far this year compared with the industry’s increase of 0.9%.
The above study is part of a collaboration agreement signed between Vir Biotechnology and British pharma giant Glaxo in April 2020 to develop antibody treatments for coronaviruses including SARS-CoV-2, the virus that causes COVID-19.
We note that the COMET clinical program for VIR-7831 has two additional clinical studies: one for the treatment of hospitalized COVID-19 patients and the other for the prophylaxis of symptomatic infection. Apart from VIR-7831, the company’s VIR-7832 antibody demonstrated high affinity for the SARS-CoV-2 spike protein and can bind the virus and potentially treat COVID-19.
Vir Biotechnology and Glaxo also expect to start a phase Ib/IIa study on VIR-7832 later in 2020. VIR-7832 shares the same characteristics as VIR-7831. Moreover, it may function as a therapeutic and/or prophylactic T cell vaccine.
Notably, monoclonal antibodies directed against the SARS-CoV-2 virus have the potential to provide effective immune response to COVID-19.
Regeneron (REGN - Free Report) initiated studies on its novel investigational antibody "cocktail" treatment REGN-COV2, which is designed to prevent the spread of SARS-CoV-2 virus and treat the same. Last month, the company announced promising first data from a descriptive analysis of a seamless phase I/II/III study, which is evaluating REGN-COV2 in non-hospitalized patients with COVID-19.
Regeneron is one of the leading biotech companies along with Gilead Sciences, Inc., working on drugs for the treatment of coronavirus. Eli Lilly (LLY - Free Report) is also making painstaking efforts to develop several potential neutralizing antibodies for the treatment of COVID-19.
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
Image: Bigstock
Vir Biotech, Glaxo Begin Phase III Study on Coronavirus Therapy
Vir Biotechnology, Inc. (VIR - Free Report) along with its partner GlaxoSmithKline (GSK - Free Report) announced that they are expanding their COMET-ICE study to phase III. The study is evaluating their monoclonal antibody candidate VIR-7831 for the early treatment of COVID-19 in patients who are at a high risk of hospitalization. Patient enrollment is currently underway in the above-mentioned study.
The companies decided to enter into phase III testing, the most crucial phase of evaluation of any drug/candidate following a positive assessment of safety and tolerability data from the lead in portion of the phase II COMET-ICE study by an Independent Data Monitoring Committee. The registrational study will now expand worldwide to additional sites in North America, South America and Europe.
VIR-7831 (also known as GSK4182136) entered into phase II/III evaluation in August 2020.
The phase III portion of the study will evaluate the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants. Initial data from the same is expected by 2020-end while complete results (primary endpoint) are expected in the first quarter of 2021. If successfully developed, VIR-7831 has the potential to advance outpatient treatment for COVID-19.
Shares of Vir Biotechnology were up 6.1% following the above announcement on Tuesday. In fact, the stock has skyrocketed 230% so far this year compared with the industry’s increase of 0.9%.
The above study is part of a collaboration agreement signed between Vir Biotechnology and British pharma giant Glaxo in April 2020 to develop antibody treatments for coronaviruses including SARS-CoV-2, the virus that causes COVID-19.
We note that the COMET clinical program for VIR-7831 has two additional clinical studies: one for the treatment of hospitalized COVID-19 patients and the other for the prophylaxis of symptomatic infection. Apart from VIR-7831, the company’s VIR-7832 antibody demonstrated high affinity for the SARS-CoV-2 spike protein and can bind the virus and potentially treat COVID-19.
Vir Biotechnology and Glaxo also expect to start a phase Ib/IIa study on VIR-7832 later in 2020. VIR-7832 shares the same characteristics as VIR-7831. Moreover, it may function as a therapeutic and/or prophylactic T cell vaccine.
Notably, monoclonal antibodies directed against the SARS-CoV-2 virus have the potential to provide effective immune response to COVID-19.
Regeneron (REGN - Free Report) initiated studies on its novel investigational antibody "cocktail" treatment REGN-COV2, which is designed to prevent the spread of SARS-CoV-2 virus and treat the same. Last month, the company announced promising first data from a descriptive analysis of a seamless phase I/II/III study, which is evaluating REGN-COV2 in non-hospitalized patients with COVID-19.
Regeneron is one of the leading biotech companies along with Gilead Sciences, Inc., working on drugs for the treatment of coronavirus. Eli Lilly (LLY - Free Report) is also making painstaking efforts to develop several potential neutralizing antibodies for the treatment of COVID-19.
Zacks Rank
Vir Biotechnology currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Biggest Tech Breakthrough in a Generation
Be among the early investors in the new type of device that experts say could impact society as much as the discovery of electricity. Current technology will soon be outdated and replaced by these new devices. In the process, it’s expected to create 22 million jobs and generate $12.3 trillion in activity.
A select few stocks could skyrocket the most as rollout accelerates for this new tech. Early investors could see gains similar to buying Microsoft in the 1990s. Zacks’ just-released special report reveals 8 stocks to watch. The report is only available for a limited time.
See 8 breakthrough stocks now>>