Eli Lilly and Company today announced additional details on its SARS-CoV-2 neutralizing antibody programs – including interim data on combination therapy in recently diagnosed patients with mild-to-moderate COVID-19 – and plans to make these therapies broadly available to patients.
Data from a new interim analysis of the BLAZE-1 clinical trial showed that combination therapy with two of Lilly’s SARS-CoV-2 neutralizing antibodies reduced viral load, symptoms and COVID-related hospitalization and ER visits.
The randomized, double-blind, placebo-controlled Phase 2 study evaluated LY-CoV555 and LY-CoV016, which bind complementary regions of the SARS-CoV-2 spike protein, for the treatment of symptomatic COVID-19 in the outpatient setting. The combination cohort enrolled recently diagnosed patients with mild-to-moderate COVID-19, who were assigned to 2800 mg of each antibody (n=112) or placebo (n=156).
The combination therapy significantly reduced viral load at day 11, meeting the primary endpoint of the study.
Lilly has now submitted an initial request for Emergency Use Authorization (EUA) for LY-CoV555 monotherapy in higher-risk patients who have been recently diagnosed with mild-to-moderate COVID-19.
“The monoclonal neutralising antibody drugs are very promising with slightly different versions being developed by several pharmaceutical companies. This announcement from Eli Lilly follows broadly similar results reported by Regeneron last week,” notes Prof Martin Landray, Professor of Medicine & Epidemiology, Nuffield Department of Population Health, University of Oxford. “Both studies show that monoclonal antibodies targeted at the coronavirus spike protein can reduce the viral load and improve symptoms. Although Eli Lilly report that fewer patients receiving the treatment were admitted to hospital or attended the emergency room than in the placebo group, this should be interpreted with caution in such a small study.”
Lilly expects to submit a subsequent request for EUA for combination therapy in November, pending clinical trial enrollment, once additional safety data accumulate and sufficient supply is manufactured. Lilly anticipates having data to support a biologics license application (BLA) submission for combination therapy as early as Q2 2021.
“There is a way to go before we know whether this class of drugs is effective in reducing the worst manifestations of COVID,” said Professor Landray. “We need to know if they improve outcomes for patients – avoid hospital admission, shorten hospital stay, reduce need for mechanical ventilation, and improve survival. Furthermore, it is important to establish how well they work in different types of patients (the elderly, particular ethnic groups, those with other disease) and at different stages of the disease (early vs. late, mild vs. severe, requiring oxygen or mechanical ventilation). Randomised clinical trials to answer these questions are now a priority. It is encouraging to see that both Eli Lilly and Regeneron have active plans for much larger trials in a range of different settings including residential care homes, outpatients, and hospital inpatients.”
Lilly says it is working to publish the monotherapy and combination therapy data in peer-reviewed journals as soon as possible.
