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www.fdanews.com/articles/202115-eli-lilly-gsk-and-vir-antibody-combination-sees-positive-results-in-phase-2-trial

Eli Lilly, GSK and VIR Antibody Combination Sees Positive Results in Phase 2 Trial

March 30, 2021

Eli Lilly’s bamlanivimab with Vir Biotechnology’s and GlaxoSmithKline’s VIR-7831 appear to be a potent antibody combination against COVID-19 infection, significantly reducing viral load in a mid-stage study.

In the phase 2 trial, patients saw a 70 percent reduction in high viral load at one week after treatment when compared to the placebo group, the companies announced yesterday. No serious adverse events were reported in the study.

Last week, GSK and Vir filed for an FDA Emergency Use Authorization for VIR-7831, after the treatment was shown to provide an 85 percent reduction in hospitalization and death rates vs. placebo (DID, March 29).

The FDA previously authorized bamlanivimab for treating COVID-19 and later authorized bamlanivimab in combination with Lilly’s other COVID-19 antibody, etesevimab (DID, Feb. 11).

The FDA recently ordered Eli Lilly and Regeneron to assess their antibody combinations against new variants (DID, March 29), and concerns about diminished antibody effectiveness caused HHS to stop distribution of bamlanivimab nationwide (DID, March 29).

Both bamlanivimab and VIR-7831 work by binding to SARS-CoV-2’ spike protein, but at different regions. According to the companies, preclinical data indicated the dual therapy could confer greater protection against variants resistant to bamlanivimab. ― Jason Scott