GSK, Vir Collaboration Drives Advanced Clinical Trial for Novel COVID-19 Antibody Forward
By Pavel Ryzhov, Ph.D.
The clinical trial landscape for COVID-19 treatment options has been steadily growing as the pandemic enters the fourth quarter of 2020. Many companies, including Gilead, Regeneron, AstraZeneca, Lilly, and others, have initiated several trials to test their medicines’ safety and efficacy. One of the common approaches is the use of monoclonal antibodies raised against SARS-CoV-2.
At this juncture, Vir Biotechnology, Inc., and GlaxoSmithKline plc, have recently announced the expansion of their joint Phase 3 clinical trial. The COVID-19 Monoclonal antibody Efficacy Trial – Intent to Care Early or COMET-ICE aims to evaluate an experimental antibody, VIR-7831, for early treatment of COVID-19 in high-risk of hospitalization patients. The antibody, also known as GSK4182136, was chosen based on virus neutralization, killing of infected cells, and simultaneously achieving high local concentration in the lungs where most of the virus spreads. It can bind to the conserved epitope shared between both SARS-CoV-1 and SARS-CoV-2, potentially making it harder for resistance to develop.
On September 30th, the Independent Data Monitoring Committee completed an assessment of the unblinded safety data. That resulted in the COMET-ICE registrational study to expand globally to further sites in North and South America and Europe. The trial aims to assess both the safety and efficacy of the intravenous infusion of VIR-7831 compared to placebo in 1,300 not-yet hospitalized patients (with equal size of treatment and placebo arms). The primary endpoint is the number of patients progressed to the point of hospitalization or death due to COVID-19 within 29 days of randomization. The companies aim to obtain interim data for safety, futility, and efficacy by the end of 2020, with the primary endpoint results expected in January 2021.
Executives from both companies expressed their enthusiasm and optimism about initiating the Phase 3 trial. George Scangos, CEO of Vir, remarked that the antibody has “characteristics that may enable it to prevent hospitalization or death via multiple mechanisms.” Hal Barron, CSO, and President R&D, GSK, acknowledged that the companies progressed VIR-7831 from pre-clinical studies to a Phase 3 trial in only six months since announcing a collaboration with Vir. He also made several comments about the clinical potential of this antibody: “We believe this neutralizing antibody’s high barrier to resistance, notable effector function and enhanced delivery into the lung suggest it has best-in-class potential in the fight against this global pandemic.”
The COMET clinical development program that Vir and GSK run jointly also involves two additional clinical trials in the future. The first is aimed at the treatment of hospitalized patients and another to prevent symptomatic infection, both of which will investigate the performance of VIR-7831. Besides, the companies plan to test VIR-7832 in Phase 1b/2a clinical trial in 2020, an antibody similar to VIR-7831 (binding a conserved epitope between SARS-CoV-1 and SARS-CoV-2), but with an enhanced effector function, suggesting an additional efficacy in treatment or prophylaxis of the disease via a T-cell response.
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