DJ Lilly, Incyte Phase 3 Study of Covid-19 Drug Didn't Meet Primary Endpoint

By Dave Sebastian

Eli Lilly & Co. and Incyte Corp. said a Phase 3 study evaluating a study of a drug applied to hospitalized Covid-19 patients didn't meet statistical significance on the primary endpoint.

The companies said they defined the primary endpoint as a difference in the proportion of participants progressing to the first occurrence of noninvasive ventilation, invasive mechanical ventilation or death by Day 28. Patients treated with baricitinib were 2.7% less likely than those receiving standard care to progress to ventilation or death, the companies said Thursday.

The treatment with baricitinib in addition to the standard care--which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both--led to a statistically significant reduction in death from any cause by 38% by Day 28, the companies said.

"While [the study] COV-BARRIER did not hit the primary endpoint based on stages of disease progression, the data show that baricitinib meaningfully reduced the risk of mortality above and beyond the recommended standard of care, without additional safety risks," said co-primary investigator E. Wesley Ely, professor of medicine at the Vanderbilt University Medical Center.

The study of 1,525 patients began in June 2020 and enrolled hospitalized patients who didn't require supplemental oxygen, the companies said.

Write to Dave Sebastian at dave.sebastian@wsj.com

(END) Dow Jones Newswires

April 08, 2021 07:14 ET (11:14 GMT)

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