COVID-19 Treatment Phase 3 Study Expands Globally
The COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) study evaluating VIR-7831 for the early treatment of COVID-19 in patients who are at high risk of hospitalization, announced its global expansion.
GlaxoSmithKline plc and Vir Biotechnology, Inc. stated an Independent Data Monitoring Committee recommended on September 30, 2020, that the study continues into Phase 3 based on a positive evaluation of safety and tolerability data from the Phase 2 lead-in.
The COMET-ICE registrational study will now expand globally to additional sites in North America, South America, and Europe.
VIR-7831 (also known as GSK4182136) is a fully human anti-SARS-CoV-2 monoclonal antibody that was selected based on its potential to neutralize the virus, kill infected cells, provide a high barrier to resistance, and achieve high concentrations in the lungs.
George Scangos, Ph.D., chief executive officer of Vir, said in a press release: “VIR-7831 is an antibody with characteristics that may enable it to prevent hospitalization or death via multiple mechanisms. We look forward to continuing to collaborate with GSK to accelerate its development.”
Dr. Hal Barron, chief scientific officer, and president R&D, GSK, added: “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 Phase 3 portion of the COMET-ICE study will assess the safety and efficacy of a single intravenous infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally (670 patients in the treatment arm and approximately 670 patients in the placebo arm).
The primary efficacy endpoint is the proportion of patients who have a progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization. Interim analyses are planned to evaluate safety, futility, and efficacy, the results of which may be available as early as the end of 2020.
Results for the primary endpoint are expected in the first quarter of 2021, with current estimates in January 2021.
The COMET clinical development program for VIR-7831 includes two additional planned trials – one for the treatment of hospitalized patients and another for the prevention of symptomatic infection. The companies also expect to start a Phase 1b/2a trial in the second half of 2020 evaluating VIR-7832, a second investigational SARS-CoV-2 neutralizing antibody that shares the same characteristics as VIR-7831, plus enhanced effector function, which may confer additional efficacy in treatment or prophylaxis by stimulating a T-cell response.
VIR-7831/GSK4182136 has been engineered with the potential to enhance lung bioavailability and have an extended half-life, said the companies.
Additional COVID-19 therapeutic development news is listed on this CoronavirusToday webpage.
PrecisionVaccinations publishes research-based COVID-19 therapeutic development news.