Phase 3 Study Launches For Oral COVID-19 Disease Treatment

An Indiana based pharmaceutical company announced the 1st patient has been enrolled in a Phase 3 study to evaluate the efficacy and safety of Olumiant for COVID-19 disease patients.

Olumiant (baricitinib) is an oral, once-daily, JAK1/JAK2 inhibitor, approved in the USA, and 70 other countries as a treatment for adults with moderately to severely active rheumatoid arthritis.

Eli Lilly and Company announced on June 15, 2020, it expects to enroll 400 patients in this late-stage study, with data expected in the next few months. 

The phase 3 study will be conducted in the U.S., Europe, and Latin America and includes patients hospitalized with SARS-CoV-2 coronavirus infection who have at least 1 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, said Lilly in its related press statement.

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 viruses. 

A manuscript detailing this mechanism of action of baricitinib in COVID-19 has been accepted for publication by EMBO Molecular Medicine.

"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, in a press statement. 

"This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment."

"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 run by the National Institute of Allergy and Infectious Diseases. 

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.

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.

The U.S. prescribing information for the approved use of baricitinib for RA includes boxed warnings regarding the use of baricitinib, including warnings about the risk for developing blood clots and serious infections. 

To learn more please visit us at Lilly.

COVID-19 disease treatment news is published by Precision Vaccinations.