Lilly, Incyte Phase 3 Study of Covid-19 Drug Didn't Meet Primary Endpoint
April 08 2021 - 7:44AM
Dow Jones News
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 07:29 ET (11:29 GMT)
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