Lilly, Glaxo, Vir See Positive Study Data for Covid-19 Treatment

By Robb M. Stewart

Eli Lilly & Co., Vir Biotechnology Inc. and GlaxoSmithKline PLC on Monday reported positive topline data from a trial of a proposed treatment for low-risk adults with Covid-19.

The companies said topline data from an expanded Phase 2 trial studying low-risk adult patients with mild to moderate Covid-19 showed that investigational bamlanivimab at 700 milligrams co-administered with VIR-7831 500 mg demonstrated a 70% relative reduction in persistently high viral load at day seven compared to the placebo, meeting the primary endpoint.

In addition, bamlanivimab administered with VIR-7831 demonstrated a statistically significant reduction compared with the placebo in the key virologic secondary endpoints of mean change from baseline to days three, five and seven in SARS-CoV-2 viral load, they said.

There were no events for the secondary endpoint of Covid-19 related hospitalization or death by day 29 in either study arm, the companies said. One patient in the treatment arm visited the emergency room for Covid-19 related symptoms, while no serious adverse events were seen with co-administration of bamlanivimab and VIR-7831.

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

VIR-7831 is an investigational compound, not approved by the U.S. Food and Drug Administration or any other regulatory authority. An emergency use authorization application for VIR-7831 has been submitted to the FDA, based on the results of a Covid-19 monoclonal antibody efficacy trial that which stopped enrollment early based on data from an interim analysis demonstrating an 85% reduction in hospitalisation or death in patients receiving VIR-7831 as monotherapy compared with a placebo.

Glaxo and Vir said they will continue discussions with the European Medicines Agency and other global regulators to make VIR-7831 available to patients with Covid-19 as soon as possible. The three companies said they anticipate engaging with global regulators, including the FDA, regarding the possible co-administration of bamlanivimab and VIR-7831 for the treatment of Covid-19.

Write to Robb M. Stewart at robb.stewart@wsj.com

(END) Dow Jones Newswires

March 29, 2021 09:29 ET (13:29 GMT)

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