On Monday, June 15, pharmaceutical giant Eli Lilly announced the beginning of a Phase 3 clinical trial for Olumiant as a potential treatment for COVID-19.
According to a press release from Lilly, “the first patient has been enrolled in a Phase 3 randomized, double-blinded, 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.”
Here’s what you should know about this landmark Phase 3 trial and what it means for the potential future treatment of the novel coronavirus.
What is Baricitinib?
Baricitinib, marketed as OLUMIANT® is currently approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. In initial clinical trials for the treatment of RA, Baricitinib was found to reduce or interrupt the passage of the virus into target cells, as well as to minimize the release of inflammatory agents.
Based on this anti-inflammatory activity, Baricitinib may be able to halt the inflammatory cascade seen in the progression of COVID-19. As explained in a clinical trial sponsored by the Hospital of Prato in Italy, “The evidence on the advantageous action of baricitinib on viral entry and cytokine outbreak constituted the rationale to perform a trial on patients with mild to moderate COVID-19 infection receiving baricitinib combined with antiviral therapy.”
How Will the Study Be Performed?
Eli Lilly plans to conduct its Phase 3 study in the United States, Latin America, and several countries in Europe. A total of 400 patients hospitalized with COVID-19 will receive daily oral doses of Olumiant or a placebo for 14 days.
All patients will be closely assessed for their response to Olumiant and the placebo. After 14 days, researchers will evaluate the primary endpoint: the proportion of patients who die or require intensive care when given Olumiant as compared to those who are given a placebo.
In addition, researchers plan to assess key secondary outcomes of the study over a 28-day period, including:
- Portion of patients with clinical improvement at different time points
- Time to recovery
- Duration of hospitalization
- Number of ventilator-free days
“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,” emphasized Patrik Jonsson, Lilly senior vice president, in a statement. “This randomized controlled study is an important step in our understanding of baricitinib as a potential COVID-19 treatment.”
Patrick Milligan, M.D, a doctor at Community Health Network of Indianapolis, one of the first sites participating in Lilly’s Phase 3 study, shared his thoughts as well. “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.”
Once this Phase 3 trial concludes, the data gathered will be used to complement data from the NIAID’s ACTT-2 study of baricitinib with remdesivir. ACCT-2 began enrolling patients in May to study the efficacy and safety of treating COVID-19 with a combination of a 4-mg daily dose of baricitinib plus remdesivir, compared to remdesivir alone.