GSK, Lilly and Vir Biotechnology achieve positive results in Phase II COVID-19 study

GlaxoSmithKline (GSK), Lilly, and Vir Biotechnology make progress against COVID-19. The three companies have announced positive initial results from the Phase II BLAZE-4 study evaluating the combination of balanivimab with VIR-7831 in low-risk adults with coronavirus. 

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What did the results reveal

The results indicated that the two monoclonal antibodies in combination have demonstrated a 70% relative reduction in persistently high viral load at seven days of treatment compared to placebo. In addition, bamlanivimad administered with VIR-7831 has demonstrated a statistically significant reduction in secondary endpoints compared to placebo. Bamlanivimab and VIR-7831 bind to different parts of the SARS-Cov-2 spyke protein. Preclinical data suggest that co-administration of these two investigational antibodies may provide protection against the current variants, which are resistant to bamlanivimab.  

“These virological data support our belief that together, bamlanivimab and VIR-7831 could be a promising option for the treatment of Covid-19,” as explained by Daniel Skovronsky, CEO and chairman of Lilly. George Scangos, CEO of Vir, commented that “this virological evaluation of two antibodies with different resistance profiles is an encouraging development in our fight against the pandemic.” 

Vir expects to continue discussions with the U.S. Food and Drug Administration (FDA) about VIR-7831 as monotherapy and co-administered with bamlanivimab. Finally, Hal Barron, CEO and president of GSK, said that these results “support our hypothesis that, by binding to a highly conserved epitope, VIR-7831 can help deliver benefits to patients.”  

VIR-7831 is not yet approved by any health authority 

VIR-7831 is an experimental compound not approved by the FDA or any health authority. The pharmaceutical consortium has applied to the FDA for emergency use authorization for VIR-7831 based on the results of the Phase III Comet-Ice study. The study has demonstrated an 85% reduction in hospitalization or death in patients who received VIR-7831 as monotherapy compared to placebo, the primary endpoint of the trial. GSK and Vir will continue discussions with the European Medicines Agency (EMA) and other regulators with the goal of making VIR-7831 available to Covid-19 patients as soon as possible.

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