Vir Biotech, Glaxo Begin Phase III Study on Coronavirus Therapy
Vir Biotechnology, Inc. VIR, along with its partner GlaxoSmithKline GSK, announced that they are expanding their COMET-ICE study to Phase III. The study examines the candidate monoclonal antibody VIR-7831 for the early treatment of COVID-19 in patients at high hospital risk. Patient enrollment for the above study is currently in progress.
The companies decided to move into Phase III testing, the most important phase of the evaluation of a drug / candidate after a positive assessment of the lead's safety and tolerability data in part of the Phase II COMET-ICE study by an independent data monitoring committee . The registration study is now being expanded to include additional locations in North America, South America and Europe.
VIR-7831 (also known as GSK4182136) entered Phase II / III assessment in August 2020.
The Phase III portion of the trial will evaluate the safety and effectiveness of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 out-of-hospital subjects. First data from this are expected by the end of 2020, while full results (primary endpoint) are expected in the first quarter of 2021. If successfully developed, VIR-7831 can advance the outpatient treatment of COVID-19.
Vir Biotechnology's shares rose 6.1% on Tuesday following the above announcement. In fact, the stock is up 230% so far this year, compared to the industry's 0.9% gain.
The above study is part of a collaboration agreement that Vir Biotechnology and UK pharmaceutical company Glaxo signed 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 includes two additional clinical trials: one for the treatment of COVID-19 patients in the hospital and one for the prophylaxis of symptomatic infections. VIR-7831 aside, the company's VIR-7832 antibody has shown 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 of VIR-7832 later in 2020. VIR-7832 has the same properties as VIR-7831. In addition, it can act as a therapeutic and / or prophylactic T-cell vaccine.
In particular, monoclonal antibodies that are directed against the SARS-CoV-2 virus can provide an effective immune response to COVID-19.
Regeneron REGN initiated studies on its novel antibody cocktail treatment REGN-COV2, which is intended to prevent and treat the spread of the SARS-CoV-2 virus. Last month, the company announced promising initial data from a descriptive analysis of a seamless Phase I / II / III study evaluating REGN-COV2 in non-hospitalized patients with COVID-19.
Regeneron, along with Gilead Sciences, Inc., is one of the leading biotech companies working on drugs for the treatment of coronaviruses. Eli Lilly LLY is also making arduous efforts to develop several potentially neutralizing antibodies for the treatment of COVID-19.
Vir Biotechnology currently has a Zacks Rank 3 (Hold). The full list of today's Zacks # 1 Rank (Strong Buy) stocks can be found here.
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