GlaxoSmithKline and partner Vir Biotechnology announced that the COMET-ICE study evaluating VIR-7831 as an early treatment for COVID-19 patients deemed to be at high risk of hospitalization will proceed into phase 3 testing, with preliminary results coming possibly before the end of this year. The companies noted that the decision follows a positive evaluation of safety and tolerability data from the phase 2 lead-in portion of the trial.
Hal Barron, president of R&D at GlaxoSmithKline, said “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 companies launched the phase 2/3 COMET-ICE study in late August, with the lead-in portion of the trial evaluating safety and tolerability of a single intravenous infusion of VIR-7831 or placebo over a 14-day period in 20 non-hospitalized patients across the US. Phase 3 will look at a single infusion of VIR-7831 or placebo in approximately 1,300 non-hospitalized participants globally. The primary efficacy endpoint is progression of COVID-19 as defined by the need for hospitalization or death within 29 days of randomization, with these data anticipated in the first quarter of 2021, likely in January.
Potential outpatient therapy
“If successful, VIR-7831 has the potential to advance outpatient treatment for COVID-19,” the companies said. The clinical development program for VIR-7831, also known as GSK4182136, comprises two additional trials, one involving hospitalized patients and another for the prevention of symptomatic infection.
GlaxoSmithKline and Vir stated they also expect to start a phase 1b/2a trial later this year to assess 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.” Both antibodies bind to an epitope on SARS-CoV-2 that is shared with the original SARS virus, “indicating that the epitope is highly conserved, which may make it more difficult for escape mutants to develop,” the companies noted.