- 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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