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

• In combination, the two monoclonal antibodies demonstrated a 70% relative reduction in persistently high viral load at day 7 compared to placebo.

Eli Lilly and Company, Vir Biotechnology, Inc. and GlaxoSmithKline plc today announced topline data from the expanded Phase 2 BLAZE-4 trial studying low-risk adult patients with mild to moderate COVID-19. Results showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831 (also known as GSK4182136) 500 mg demonstrated a 70 percent (p<0.001) relative reduction in persistently high viral load (> 5.27; cycle threshold value < 27.5) at day 7 compared to placebo, meeting the primary endpoint.

In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared to placebo in the key virologic secondary endpoints of mean change from baseline to days 3, 5 and 7 in SARS-CoV-2 viral load. There were no events for the secondary endpoint of COVID-19 related hospitalisation or death by day 29 in either study arm. One patient (in the treatment arm) visited the emergency room for COVID-19 related symptoms. No serious adverse events were seen with co-administration of bamlanivimab and VIR-7831.

Bamlanivimab and VIR-7831 bind to different regions of the spike protein of SARS-CoV-2. Preclinical data suggest the administration of these two investigational antibodies together may provide protection against current variants of SARS-CoV-2 that are resistant to bamlanivimab.

Daniel Skovronsky, M.D., Ph.D., Lilly's Chief Scientific Officer and President of Lilly Research Laboratories said: “The reduction in persistently high viral load is an important virology endpoint that was demonstrated in Lilly’s Phase 2 BLAZE-1 trial, and subsequently validated in the Phase 3 trial, to be strongly correlated with the clinical outcome of COVID-19 related hospitalisations and deaths in high-risk patients. These virology data support our belief that bamlanivimab and VIR-7831 together could be a promising option for COVID-19 treatment.”

George Scangos, Ph.D., Chief Executive Officer of Vir said: “This virologic evaluation of two antibodies with distinct resistance profiles is an encouraging advance in our fight against the pandemic. VIR-7831 demonstrated positive results in the COMET-ICE trial and recent pre-clinical data suggest that VIR-7831 maintains activity against current circulating variants of concern. Now, with these exciting new data from the BLAZE-4 trial, we believe that VIR-7831 has an important role to play as both monotherapy and in combination with other mAbs. We look forward to continuing conversations with the FDA about VIR-7831 as monotherapy and co-administered with bamlanivimab.”

Dr. Hal Barron, Chief Scientific Officer and President R&D, GSK, said: “These early data from the BLAZE-4 trial, coupled with the results of the COMET-ICE trial demonstrating an 85 percent reduction in progression to hospitalisation or death using VIR-7831, support our hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients. 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.”

VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration (FDA) or any other regulatory authority. An Emergency Use Authorization (EUA) application for VIR-7831 has been submitted to the FDA, based on the results of the COMET-ICE (COVID-19 Monoclonal antibody Efficacy Trial - Intent to Care Early) trial, which stopped enrollment early based on data from an interim analysis demonstrating an 85 percent reduction in hospitalisation or death in patients receiving 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 global regulators to make VIR-7831 available to patients with COVID-19 as soon as possible. The three companies anticipate engaging with global regulators, including the FDA, regarding the possible co-administration of bamlanivimab and VIR-7831 for the treatment of COVID-19.