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Lilly provides comprehensive update on progress of SARS-CoV-2 neutralizing antibody programs

Published: 2020-10-07 12:30:00 ET

- Lilly submitted request for emergency use authorization (EUA) for monotherapy to U.S. Food and Drug Administration (FDA)

- New data show combination therapy met primary and secondary endpoints, reducing viral load, symptoms and hospitalizations; EUA request to follow

- Plan to initiate a large open-label pragmatic study in COVID-19 outpatients in October

- Media and investor call to be held at noon EDT today

INDIANAPOLIS, Oct. 7, 2020 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY) 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.

"Our teams have worked tirelessly the last seven months to discover and develop these potential antibody treatments," said Daniel Skovronsky, M.D., Ph.D., Lilly's chief scientific officer and president of Lilly Research Laboratories. "We believe the data generated to date provide sufficient evidence that both monotherapy and combination therapy may be effective to treat COVID-19 in patients with a high risk for serious outcomes. Lilly is diligently working with regulators around the world to make these treatments available."

Investors, media and the general public are invited to a conference call today at noon EDT, where Lilly will provide more data and discussion on these programs. The webcast information is available here. A replay will also be available on the website following the conference call.

Combination therapy clinical trial dataData 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 (p=0.011), meeting the primary endpoint of the study. Most patients, including those receiving placebo, demonstrated near complete viral clearance by day 11. Further, combination treatment reduced viral levels at day 3 (p=0.016) and day 7 (p

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