Eli Lilly-Incyte's Baricitinib Study In Hospitalized COVID-19 Patients Fails To Meet Main Goal - Eli Lilly and Co (NYSE:LLY), Incyte (NASDAQ:INCY)

Eli Lilly And Co LLY and Incyte Corporation INCY have reported results from the COV-BARRIER Phase 3 study evaluating baricitinib plus standard of care (SoC) versus placebo plus SoC in hospitalized COVID-19 patients.
The trial did not meet statistical significance on the primary endpoint of the proportion of participants progressing to non-invasive ventilation or death by Day 28.
Baricitinib-treated patients were 2.7% less likely than those receiving standard of care to progress to ventilation (non-invasive or mechanical) or death.
Treatment with baricitinib in addition to SoC (which included 79% receiving corticosteroids and 19% receiving remdesivir, with some receiving both) resulted in a significant reduction in death from any cause by 38%.
A numerical reduction in mortality was observed for all baseline severity subgroups of baricitinib-treated patients. It was most pronounced for patients receiving non-invasive mechanical ventilation at baseline (17.5% versus 29.4% for baricitinib plus SoC versus SoC.
The frequency of adverse events was generally similar in the baricitinib and placebo groups.
Severe infections and venous thromboembolism occurred in 8.5% and 2.7% of patients treated with baricitinib, respectively, versus 9.8 % and 2.5% on placebo.
Lilly intends to publish detailed results of this study in a peer-reviewed journal in the coming months.
The company will share the data from the study with regulatory authorities in the U.S., European Union, and other geographies to evaluate the next steps for baricitinib in hospitalized COVID-19 patients.
Yesterday, the FDA extended the review period for baricitinib in atopic dermatitis by three months.
Price Action: LLY shares are up 0.3% at $182.8 in premarket trading on the last check Thursday, while INCY shares closed 2.2% lower at $81.38 on Wednesday.

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