Eli Lilly and Company ( LLY Quick Quote LLY - Free Report) and Incyte Corporation ( INCY Quick Quote INCY - Free Report) announced that a phase III study — COV-BARRIER — evaluating their JAK inhibitor candidate, Olumiant (baricitinib) in combination with standard of care (SoC) in hospitalized COVID-19 patients failed to meet its primary endpoint.
Lilly’s stock has increased 8.1% so far this year against the
industry’s decline of 0.6%.
Data from the late-stage study showed that Olumiant plus SoC, including
Gilead’s ( GILD Quick Quote GILD - Free Report) remdesivir, failed to achieve statistically significant difference in proportion of patients progressing to noninvasive ventilation, invasive mechanical ventilation or death compared to placebo by day 28. The data showed that patients who were treated with Olumiant were 2.7% less likely to progress to ventilation or death than those receiving standard of care, which is not a statistically significant improvement.
Lilly plans to share the data from the COV-BARRIER study with regulatory authorities in different countries to evaluate the future steps of development for baricitinib in this patient population.
However, treatment with Olumiant in addition to SoC achieved a significant reduction of 38% in death from any cause by day 28. The Olumiant-combo regimen also reduced mortality in severe patients.
The COV-BARRIER study was conducted to complement the previously completed ACTT-2 study sponsored by the National Institute of Allergy and Infectious Diseases (NIAID). Data from the study had shown that addition of Olumiant to SoC reduced median time to recovery. Moreover, Olumiant plus remdesivir significantly reduced proportion of patients whose disease progressed to next-stage compared to remdesivir alone.
Please note that Olumiant in combination with remdesivir is approved for emergency use in the United States for treating severe hospitalized patients including patients requiring supplemental oxygen, invasive mechanical ventilation, or extracorporeal membrane oxygenation. Data from COV-BARRIER and ACTT-2 studies support use of baricitinib for treating certain hospitalized patients with COVID-19 due to its potential effect on mortality. Moreover, Olumiant is also approved for treating rheumatoid arthritis and atopic dermatitis.
Meanwhile, several combination regimens of baricitinib are also being evaluated in different clinical studies for COVID-19 patients in different stages of hospitalization.
Zacks Rank & Stock to Consider
Lilly currently has a Zacks Rank #3 (Hold).
Moderna, Inc. ( MRNA Quick Quote MRNA - Free Report) is a better-ranked stock from the biotech sector carrying a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Moderna’s earnings per share estimates have moved up from $11.45 to $14.96 for 2021 in the past 60 days. The stock has soared 28.1% so far this year.
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