Eli Lilly disclosed on Monday that it has started a Phase Three clinical trial for Olumiant (baricitinib) as a possible COVID-19 drug. Olumiant has already been granted clearance for the treatment of moderate to severe rheumatoid arthritis and Eli Lilly believes it could help prevent cytokine storms in patients with severe coronavirus infections.
The company also believes that Olumiant could block host cells from producing copies of the disease-causing SARS-CoV-2 virus. The trial is one of several efforts by the US biotech group to help contain the coronavirus pandemic which, according to a Reuters report, has killed over 400,000 people worldwide.
The drug is being tested to see if deaths from COVID-19 disease can be reduced and its severity lowered. Lilly scientists agree that baricitinib may help suppress the potentially deadly immune response and diminish the ability of COVID-19 to replicate in infected cells.
Eli Lilly, based in Indianapolis, said the latest study will complement ongoing research of the rheumatoid arthritis drug in partnership with the National Institute of Allergy and Infectious Diseases.
Lilly stated it intends to enroll about 400 patients in the double-blind, placebo-controlled study that will include patients hospitalized with SARS-CoV-2 infection who have at least one elevated inflammation marker but do not require invasive mechanical ventilation at the entry to the study.
The study is expected to increase similar efforts to examine the use of baricitinib in conjunction with Gilead Sciences. Recently Gilead's antiviral drug won U.S. use of emergency authorization.
Gilead's antiviral vaccine recently won emergency authorization use from the U.S. Food and Drug Administration after a study discovered it cut COVID-19 patients' hospital stays by four days or about a third.
Lilly Bio-Medicines president Patrik Jonsson told Fierce Pharma that Olumiant could represent a very important first step in minimizing mortality rates for patients suffering COVID-19.
"It is not going to be the final step," Jonsson disclosed. Instead, antibody vaccines would represent that "final step" toward quelling COVID-19, he said. For the Phase Three study, Lilly is planning to enroll patients in the US, Europe, and Latin America and expects opening sites where "we see a spike or significant increase" in COVID-19 infections, Angus Liu of Fierce Pharma, reported.
Eli Lilly has launched two additional clinical trials for future therapies with COVID-19. It announced last week it was initiating a Phase 1 trial for JS016, an investigational antibody therapy.
Eli Lilly is working with Junshi Biosciences which will jointly perform a Phase 1 trial in China for JS016. In healthy participants who have not been diagnosed with COVID-19, this trial will test the safety, tolerability, immunogenicity, and pharmacokinetics.
