Vir Biotechnology, Inc. ( VIR Quick Quote VIR - Free Report) along with its partner GlaxoSmithKline ( GSK Quick Quote 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.
REGN Quick Quote 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 Quick Quote 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
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