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Eli Lilly Launches Phase 3 Trial with Baricitinib for COVID-19 Patients
By Judy Ya-Hsuan Lin
Many pharmaceutical companies are fighting against COVID-19, and Eli Lilly is no exception. Lilly is enrolling trial subjects for a Phase 3 study evaluating baricitinib, an FDA approved rheumatoid arthritis treatment, in hospitalized patients with COVID-19.
Baricitinib (OLUMIANT) is a once-daily, oral JAK inhibitor that shows inhibitory potency against JAK enzymes, including JAK1, JAK2, and TYK2. A product of a 2009 collaboration between Lilly and Nevada-based Incyte, the drug was intended to be developed and commercialized for patients suffering from inflammatory and autoimmune diseases. Although it is currently elusive as to which JAK enzymes need to be inhibited explicitly for the drug to achieve maximum therapeutic potential, a number of inflammatory and autoimmune diseases have been found to be associated with JAK-dependent cytokines.
Based on several observations, the increased disease severity observed in COVID-19 is also linked to a hyperinflammatory state. Therefore, in recent months, the JAK inhibitor is also evaluated for its efficacy against the novel coronavirus infection. According to Vincent C. Marconi, M.D., Professor of Medicine and Global Health at Emory University School of Medicine, “several ongoing studies with baricitinib will provide necessary data about this treatment that may combine antiviral activity with suppression of cytokine storm.”
Lilly has launched a Phase 3, placebo-controlled study to test the hypothesis that baricitinib could inhibit JAK1 and JAK2 enzymes to reduce the cytokine storm of COVID-19. Besides, the drug may have the potential to obstruct host cell proteins involved in viral reproduction. In fact, a manuscript that discusses this mechanism of action has been accepted for publication by the journal EMBO Molecular Medicine.
The study will be conducted in the U.S., Europe, and Latin America, with an expected enrollment of 400 hospitalized COVID-19 patients. One of the criteria for enrollment is “patients who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry,” meaning patients with less severe symptoms qualify to participate at the beginning of the trial.
The primary endpoint of the study is to examine the proportion of patients who die or require non-invasive ventilation/high-flow oxygen, or invasive mechanical ventilation at day 28 when treated with 4 mg of baricitinib daily as compared to placebo. Secondary endpoints of the study include the proportion of patients showing clinical improvement at the time required for recovery, duration of hospitalization, number of ventilator-free days, and mortality over the 28-day period.
The data will complement the ongoing study of baricitinib with remdesivir in the second phase of the Adaptive COVID-19 Treatment Trial (ACTT-2) carried out by the National Institute of Allergy and Infectious Diseases (NIAID) under the National Institutes of Health (NIH). The ACTT-2 trial evaluates the efficacy and safety of the combination of a 4 mg daily dose of baricitinib plus remdesivir, compared to remdesivir only.
“Following upon the success of remdesivir to treat moderate to severe COVID-19, hospitalized patients are still in need of novel approaches to reduce mortality,” said Vincent C. Marconi, M.D., professor of medicine and global health at Emory University School of Medicine and Emory’s Rollins School of Public Health. “Several ongoing studies with baricitinib will provide necessary data about this treatment that may combine antiviral activity with suppression of cytokine storm.”
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