Topline data were announced from the expanded phase 2 BLAZE-4 trial investigating bamlanivimab (Lilly) in combination with VIR-7831 (GlaxoSmithKline and Vir Biotechnology) in low-risk adults with mild to moderate COVID-19.
Bamlanivimab and VIR-7831 are monoclonal antibodies that work by binding to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest that the combination of bamlanivimab and VIR-7831 may provide protection against current SARS-CoV-2 variants that have been resistant to bamlanivimab.
The randomized, double-blind, placebo-controlled trial (ClinicalTrials.gov: NCT04634409) included low-risk adults with mild to moderate COVID-19 who were randomly assigned to receive bamlanivimab alone, bamlanivimab in combination with etesevimab or VIR-7831, or placebo. Results showed a 70% relative reduction in persistently high viral load at day 7 with bamlanivimab 700mg plus VIR-7831 500mg compared with placebo (P <.001). Moreover, statistically significant reductions in key virologic secondary endpoints (ie, mean change from baseline to days 3, 5, and 7 in SARS-CoV-2 viral load) were observed with the combination.
By day 29, there were no reported COVID-19 related hospitalizations or deaths in either study arm. Co-administration of bamlanivimab and VIR-7831 did not result in any serious adverse events; 1 patient visited the emergency room for COVID-19 related symptoms when receiving the combination therapy.
“These early data from the BLAZE-4 trial, coupled with the results of the COMET-ICE trial demonstrating an 85% reduction in progression to hospitalization or death using VIR-7831, support our hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients,” said Dr Hal Barron, chief scientific officer and president R&D, GSK. “We’re continuing to work with regulators to bring VIR-7831 as a monotherapy and potentially co-administered with other monoclonal antibodies to patients in need.”
An Emergency Use Authorization (EUA) application has been submitted to the FDA for VIR-7831 monotherapy as an early treatment for COVID-19 in adults and adolescents. Bamlanivimab is currently authorized by the Food and Drug Administration (FDA) for emergency use as monotherapy and combination therapy with etesevimab for patients at high risk for progressing to severe COVID-19.
Lilly, Vir Biotechnology and GSK announce positive topline data from the phase 2 BLAZE-4 trial evaluating bamlanivimab with VIR-7831 in low-risk adults with COVID-19. [press release]. Indianapolis, IN and San Francisco, CA and London, United Kingdom: Eli Lilly and Company; March 29, 2021.