Phase 2 trial evaluating Bamlanivimab with VIR-7831 against COVID-19 yields positive topline data

Eli Lilly, Vir Biotechnology and GlaxoSmithKline (GSK) have reported 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% relative reduction in persistently high viral load 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 hospitalization 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, 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 hospitalizations 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, CEO 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.”

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 hospitalization or death using VIR-7831, support our hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients.”

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