The combined use of the monoclonal antibodies bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg in Covid-19 patients achieves a relative reduction of 70% in the persistence of a high viral load in on day 7 of treatment compared to placebo. This is demonstrated by the results of the phase II BLAZE-4 study in low-risk patients with mild to moderate Covid-19 launched by the companies Lilly, Vir Biotechnology and GSK.
According to the study, bamlanivimab administered with VIR-7831 has shown a statistically significant reduction, compared to placebo, in virological secondary endpoints of the mean change in SARS-CoV-2 viral load from baseline to days 3, 5 and 7. There were no events for the secondary endpoint of Covid-19-related hospitalization or death on day 29 in either arm of the study. No serious adverse effects were observed with co-administration of bamlanivimab and VIR-7831 .
Bamlanivimab and VIR-7831 bind to different regions of the spyke protein of SARS-CoV-2 . Preclinical data suggest that co-administration of these two investigational antibodies may provide protection against current variants of SARS-CoV-2 that are resistant to bamlanivimab.
Daniel Skovronsky , MD, Ph.D., Lilly’s Chief Scientific Officer and President of Lilly Research Laboratories commented that: “ The reduction of persistently high viral load is an important virological endpoint that was demonstrated in the phase II BLAZE trial. -1 from Lilly , and later validated in the phase III trial, to be closely related to the clinical outcome of Covid-19- related hospitalizations and deaths in high-risk patients. These virological data support our belief that together, bamlanivimab and VIR-7831, could be a promising option for the treatment of Covid-19 ”.
For his part, George Scangos , Ph.D., Vir’s Chief Executive Officer, has assured that “the virological evaluation of two antibodies with different resistance profiles is an encouraging advance in our fight against the pandemic. VIR-7831 demonstrated positive results in the COMET-ICE trial and recent preclinical data suggest that VIR-7831 maintains activity against currently circulating variants of interest . Now, with these exciting new data from the BLAZE-4 trial, we believe that VIR-7831 has a important role to play both as monotherapy and in combinationwith other mAbs. We look forward to continuing discussions with the FDA regarding VIR-7831 as monotherapy and co-administered with bamlanivimab . “
The companies have applied to the US FDA for Emergency Use Authorization (EAU) for VIR-7831 based on the results of the phase III COMET-ICE ( Covid-19 Monoclonal antibody Efficacy Trial – Intent) study. to Care Early) that has stopped enrolling patients early based on the results of an interim analysis showing an 85% reduction in hospitalization or death in patients receiving VIR-7831 as monotherapy compared to placebo, the criterion primary endpoint of the trial. GSK and Vir will continue in discussions with the European Medicines Agency (EMA) and other regulators with the aim of make VIR-7831 available to Covid-19 patients as soon as possible.