GlaxoSmithKline plc GSK announced that its partner Vir Biotechnology VIR has initiated a phase II/III study — COMET-ICE — to develop a monoclonal antibody candidate — VIR-7831 (also known as GSK4182136) — for the early treatment of COVID-19 in patients who are at high risk of hospitalization. The first patient in the study was dosed with the candidate last week.
The study will evaluate a single 500mg dose of the candidate for prevention of hospitalization of COVID-19 patients with early symptomatic infection. The companies expect initial results from the study before year-end and complete results in the first quarter of 2021. They also anticipate early access to the potential antibody treatment as soon as the first half of 2021.
The study is part of a collaboration agreement between Glaxo and Vir Biotechnology signed in April to develop antibody treatments for coronaviruses including SARS-CoV-2.
Vir Biotechnology has identified several specific antibody candidates using its proprietary monoclonal antibody platform technology. These include VIR-7831 and VIR-7832 antibodies that have demonstrated high affinity for the SARS-CoV-2 spike protein and can bind the virus and potentially treat COVID-19. Per the deal, Vir’s proprietary technology will be combined with Glaxo’s expertise in functional genomics to accelerate these promising antibody candidates directly into phase II clinical studies, subject to regulatory review. The companies will also work to find new anti-viral antibodies that could be developed into potential treatments for COVID-19 as well as research on SARS-CoV-2 and other coronavirus vaccines.
Glaxo’s shares have declined 15.7% this year so far against the industry’s 1.6% increase.
We note that pre-clinical data on VIR-7831 have shown high potency in neutralizing SARS-CoV-2 that suggests a high barrier to resistance and an ability to recruit immune cells to kill already infected cells. The phase II/III study has two parts that will evaluate the candidate in patients with mild or moderate COVID-19 who are at high risk of progression to severe disease. The first part of the study will evaluate VIR-7831 in non-hospitalized patients for assessment of safety. The second and expansion phase of the study will progress with the aim of reducing the need for hospitalization.
Glaxo and Vir Biotechnology have plans to initiate two additional clinical studies to evaluate VIR-7831 for the treatment of severely ill hospitalized COVID-19 patients, and prophylaxis of symptomatic infection. The companies also expect to start clinical study on VIR-7832 later this year. VIR-7832 shares the same characteristics as VIR-7831. Moreover, it may also function as a therapeutic and/or prophylactic T cell vaccine.
We note that Gilead’s GILD Veklury (remdesivir) is the only drug to receive an emergency use authorization for treating all hospitalized COVID-19 patients.
Meanwhile, several other pharma companies are developing antibody treatments for COVID-19. AstraZeneca AZN and Regeneron are conducting clinical studies, separately, on cocktail COVID-19 antibody therapies. Moreover, Lilly and Amgen are also involved in developing antibody treatments.
Zacks Rank
Glaxo currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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