29.03.2021 14:58:45

Lilly, Vir And GSK Announce Positive Data From Phase 2 BLAZE-4 Trial On COVID-19

(RTTNews) - Eli Lilly and Co. (LLY), Vir Biotechnology Inc. (VIR) and GlaxoSmithKline plc (GSK, GSK.L) said results from phase 2 BLAZE-4 trial, which is studying low-risk adult patients with mild to moderate COVID-19, showed that investigational bamlanivimab (LY-CoV555) 700 mg co-administered with VIR-7831--also known as GSK4182136-- 500 mg demonstrated a 70 percent relative reduction in persistently high viral load at day 7 compared to placebo. It was 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.

The companies noted that 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.

Hal Barron, chief scientific officer and president R&D, GSK, said that the 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 hypothesis that by targeting a highly conserved epitope, VIR-7831 may help deliver benefits to patients.

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.

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