Lilly Begins a Phase 3 Clinical Trial with Baricitinib for Hospitalized COVID-19 Patients
06/15/2020
- Study Will Further Understanding of Baricitinib's Potential as a COVID-19 Treatment?- Data Will Complement Ongoing NIAID Trial and Investigator-Initiated Trials
INDIANAPOLIS,?June 15, 2020?/PRNewswire/ --?Eli Lilly and Company?(NYSE: LLY) announced today that the first patient has been enrolled in a Phase 3 randomized, double-blind, placebo?controlled study to evaluate the efficacy and safety of baricitinib, an oral JAK1/JAK2 inhibitor licensed from Incyte, in hospitalized adults with COVID-19. Baricitinib, marketed as OLUMIANT?, is approved in 70 countries as a treatment for adults with moderately to severely active rheumatoid arthritis (RA).
Lilly?expects to enroll 400 patients in the trial, with data expected in the next few months. The study will be conducted in the?U.S.,?Europe?and?Latin America?and includes patients hospitalized with SARS-CoV-2 infection who have at least one elevated marker of inflammation but do not require invasive mechanical ventilation at study entry.
In COVID-19 infection, increased disease severity can be associated with a hyperinflammatory state. It is hypothesized that through JAK1 and JAK2 inhibition, baricitinib may reduce the cytokine storm associated with the complications of this infection. In addition, baricitinib may have a role in inhibiting the host cell proteins that assist in viral reproduction, reducing the ability of infected cells to make more virus. A manuscript detailing this mechanism of action of baricitinib in COVID-19 has been accepted for publication by?EMBO Molecular Medicine.
The primary endpoint for?Lilly's study is the proportion of patients who die or require non-invasive ventilation/high-flow oxygen or invasive mechanical ventilation by Day 28 in patients treated with 4 mg of baricitinib daily (with background therapy) compared to placebo (with background therapy). Patients will receive baricitinib or placebo for up to 14 days or until discharge from the hospital. Key secondary outcomes of this study include the proportion of patients with clinical improvement at different time points, time to recovery, duration of hospitalization, number of ventilator-free days and mortality over a 28-day period.
"Lilly?is committed to fighting this global pandemic, and this includes testing whether existing medicines including baricitinib could help treat the complications of COVID-19 in patients," said?Patrik Jonsson,?Lilly?senior vice president and president of?Lilly?Bio-Medicines. "This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment."
"While the approach to addressing COVID-19 continues to evolve, we're pleased to partner with?Lilly?in this trial to assess baricitinib's potential in the fight against COVID-19 and look forward to learning more about its impact on patients," said?Patrick Milligan, M.D., of Community Health Network in?Indianapolis,?U.S., one of the first sites participating in the study.
"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."
The data from?Lilly's trial will complement data from?the study of baricitinib?with remdesivir in the second phase of the Adaptive COVID-19 Treatment Trial (ACTT-2) run by the?National Institute of Allergy and Infectious Diseases?(NIAID), part of the?National Institutes of Health?(NIH). This study ? which enrolled its first patient last month ? assesses the efficacy and safety of the combination of a 4-mg daily dose of baricitinib plus remdesivir, compared to remdesivir.
Lilly?is also supporting select ongoing multisite and single-site investigator-initiated trials in?Europe?and?North America?for hospitalized patients with COVID-19 infections. These studies by academic and government institutions will provide information on hundreds of additional patients treated with baricitinib and either placebo or active comparators.
Should research efforts for baricitinib in COVID-19 prove successful,?Lilly?will continue to create adequate supply to support both appropriate clinical and investigational use.
Studying baricitinib in controlled trials is important in order to better characterize its potential benefits and understand the safety of its use as a COVID-19 treatment. The?U.S.?prescribing information for the approved use of baricitinib for RA includes boxed warnings regarding the use of baricitinib, including warnings about risk for developing blood clots and serious infections.
About?Lilly's COVID-19 Efforts
Lilly?is bringing the full force of its scientific and medical expertise to attack COVID-19 around the world. We are fighting the pandemic with everything we can: discovering potential medicines to treat and prevent COVID-19, maintaining a reliable supply of our medicines, and supporting patients and communities in times of need.?Lilly?is studying multiple approaches to treat COVID-19, including potential antibodies designed specifically to attack the virus and existing?Lilly?medicines to understand their potential in treating complications of COVID-19.
Indication and Usage for OLUMIANT (baricitinib) tablets (in?the United States) for RA patients
OLUMIANT??(baricitinib) 2-mg is indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis who have had an inadequate response to one or more tumor necrosis factor (TNF) antagonist therapies.?Limitation of Use: Use of OLUMIANT in combination with other JAK inhibitors, biologic disease-modifying antirheumatic drugs (DMARDs), or with potent immunosuppressants such as azathioprine and cyclosporine is not recommended.
IMPORTANT SAFETY INFORMATION FOR OLUMIANT (baricitinib) TABLETS?
WARNING: SERIOUS INFECTIONS, MALIGNANCY, AND THROMBOSIS
SERIOUS INFECTIONS:?Patients treated with Olumiant are at risk for developing serious infections that may lead to hospitalization or death. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. If a serious infection develops, interrupt Olumiant until the infection is controlled. Reported infections include:
- Active tuberculosis (TB), which may present with pulmonary or extrapulmonary disease. Test patients for latent TB before initiating Olumiant and during therapy. Treatment for latent infection should be considered prior to Olumiant use.
- Invasive fungal infections, including candidiasis and pneumocystosis. Patients with invasive fungal infections may present with disseminated, rather than localized, disease.
- Bacterial, viral, and other infections due to opportunistic pathogens.
- with chronic or recurrent infection
- who have been exposed to TB
- with a history of a serious or an opportunistic infection
- who have resided or traveled in areas of endemic tuberculosis or endemic mycoses; or
- with underlying conditions that may predispose them to infection.
Refer to: | Kristen Basu;?basu_kristen_porter@lilly.com; +1-317-447-2199 (media) |
Kevin Hern;?hern_kevin_r@lilly.com; +1-317-277-1838 (investors) |
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SOURCE?Eli Lilly and Company