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Lilly/Vir's Cocktail COVID-19 Therapy Meets Study Endpoint
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Eli Lilly (LLY - Free Report) along with Vir Biotechnology (VIR - Free Report) and GlaxoSmithKline (GSK - Free Report) announced positive top-line data from the expanded phase II study — BLAZE-4 — evaluating a cocktail of two antibodies low-risk adult patients with mild-to-moderate COVID-19. The study evaluated 700mg of Lilly’s bamlanivimab (LY-CoV555) co-administered with 500mg of Vir’s VIR-7831.
Data from the study demonstrated that the cocktail therapy achieved a 70% relative reduction in persistently high viral load after seven days of treatment compared to placebo. The therapy also demonstrated statistically significant reduction of mean change in viral load at day 3, 5 and 7 from baseline. Moreover, there were no COVID-19 related hospitalizations or deaths after 29 days of treatment.
In February, Lilly announced a deal with Vir and Glaxo to develop the combination therapy for certain COVID-19 patients.
So far this year, Lilly’s stock has risen 10.3% compared with an increase of 0.7% for the industry.
The two monoclinal antibodies — bamlanivimab and VIR-7831 — treat COVID-19 by binding with different regions of the spike protein of SARS-CoV-2, and thereby may achieve better efficacy compared to either of them alone. Pre-clinical data suggests that the combination of these two antibodies may protect against current variants of SARS-CoV-2 that are resistant to bamlanivimab.
Please note that bamlanivimab was granted emergency use authorization (“EUA”) by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. It is also authorized for emergency/temporary use in numerous countries for this indication. Moreover, bamlanivimab in combination with Lilly’s another antibody candidate, etesevimab, was granted EUA last month. Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor, Olumiant, is also approved for emergency use in combination with Gilead’s remdesivir to treat hospitalized COVID-19 patients.
Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. Sales should be higher in 2021 with emergency approval received for bamlanivimab/etesevimab cocktail. In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.
Although VIR-7831 is yet to receive an approval or EUA for any indication, the candidate has demonstrated encouraging progress as monotherapy in a late-stage study. Interim data from the phase III COMET-ICE study evaluating VIR-7831 monotherapy, for the early treatment of COVID-19 in adults who are at high risk of hospitalization, showed that it led to 85% reduction in hospitalization or death as compared to placebo.
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Lilly/Vir's Cocktail COVID-19 Therapy Meets Study Endpoint
Eli Lilly (LLY - Free Report) along with Vir Biotechnology (VIR - Free Report) and GlaxoSmithKline (GSK - Free Report) announced positive top-line data from the expanded phase II study — BLAZE-4 — evaluating a cocktail of two antibodies low-risk adult patients with mild-to-moderate COVID-19. The study evaluated 700mg of Lilly’s bamlanivimab (LY-CoV555) co-administered with 500mg of Vir’s VIR-7831.
Data from the study demonstrated that the cocktail therapy achieved a 70% relative reduction in persistently high viral load after seven days of treatment compared to placebo. The therapy also demonstrated statistically significant reduction of mean change in viral load at day 3, 5 and 7 from baseline. Moreover, there were no COVID-19 related hospitalizations or deaths after 29 days of treatment.
In February, Lilly announced a deal with Vir and Glaxo to develop the combination therapy for certain COVID-19 patients.
So far this year, Lilly’s stock has risen 10.3% compared with an increase of 0.7% for the industry.
The two monoclinal antibodies — bamlanivimab and VIR-7831 — treat COVID-19 by binding with different regions of the spike protein of SARS-CoV-2, and thereby may achieve better efficacy compared to either of them alone. Pre-clinical data suggests that the combination of these two antibodies may protect against current variants of SARS-CoV-2 that are resistant to bamlanivimab.
Please note that bamlanivimab was granted emergency use authorization (“EUA”) by the FDA in November 2020 as a monotherapy for high-risk patients recently diagnosed with mild-to-moderate COVID-19. It is also authorized for emergency/temporary use in numerous countries for this indication. Moreover, bamlanivimab in combination with Lilly’s another antibody candidate, etesevimab, was granted EUA last month. Lilly and Incyte’s (INCY - Free Report) oral JAK inhibitor, Olumiant, is also approved for emergency use in combination with Gilead’s remdesivir to treat hospitalized COVID-19 patients.
Bamlanivimab was a key driver of Lilly’s sales growth in the fourth quarter, contributing $871.2 million in sales due to a key supply contract with the U.S. government. Sales should be higher in 2021 with emergency approval received for bamlanivimab/etesevimab cocktail. In fact, in 2021, Lilly expects to generate revenues in the range of $1-$2 billion from COVID-19 therapies.
Although VIR-7831 is yet to receive an approval or EUA for any indication, the candidate has demonstrated encouraging progress as monotherapy in a late-stage study. Interim data from the phase III COMET-ICE study evaluating VIR-7831 monotherapy, for the early treatment of COVID-19 in adults who are at high risk of hospitalization, showed that it led to 85% reduction in hospitalization or death as compared to placebo.
Eli Lilly and Company Price
Eli Lilly and Company price | Eli Lilly and Company Quote
Zacks Rank
Lilly currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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The biotech sector is projected to surge beyond $775 billion by 2024 as scientists develop treatments for thousands of diseases. They’re also finding ways to edit the human genome to literally erase our vulnerability to these diseases.
Zacks has just released Century of Biology: 7 Biotech Stocks to Buy Right Now to help investors profit from 7 stocks poised for outperformance. Our recent biotech recommendations have produced gains of +50%, +83% and +164% in as little as 2 months. The stocks in this report could perform even better.
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