BioPharma

Lilly launches Phase III study of arthritis drug in Covid-19

The company said it had initiated the Phase III study of Olumiant, one of multiple JAK inhibitors that are being tested to find if they can mitigate the cytokine storm associated with Covid-19's worst complications.

By Alaric DeArment on June 16, 2020

This illustration, created at the Centers for Disease Control and Prevention (CDC), reveals ultrastructural morphology exhibited by coronaviruses

A drug used to treat arthritis has become the latest to enter late-stage clinical testing as a potential anti-inflammatory agent in patients with Covid-19.

Indianapolis-based Eli Lilly said Monday that it had started a Phase III clinical trial of Olumiant (baricitinib) among patients hospitalized with Covid-19 who have at least one elevated marker for inflammation, but do not require mechanical ventilation.

The company said the randomized, placebo-controlled study is designed to enroll 400 patients at sites in the U.S., Latin America and Europe. Currently, 15 sites in the U.S. Mexico, Spain and Germany are listed. Patients in the control arm will receive placebo on top of background therapy. The primary endpoint is the percentage of patients who die or require ventilation or high-flow oxygen, while secondary endpoints include the percentage of patients with at least a one-point improvement in the ordinal scale of clinical status or who are discharged from the hospital. The ClinicalTrials.gov database lists the study as not yet recruiting, having been posted on the site on June 9.

Olumiant is a JAK1/JAK2 inhibitor approved for rheumatoid arthritis. The hypothesis of testing it in Covid-19 is that through its anti-inflammatory pathway, it may be able to reduce the cytokine storm associated with the complications caused by Covid-19, and the potential of its mechanism of action in Covid-19 is the subject of an upcoming scientific paper. Other JAK inhibitors, like Jakafi (ruxolitinib) from Incyte – which licensed Olumiant to Lilly – and Pfizer’s Xeljanz (tofacitinib) are also being tested in Covid-19. Olumiant in particular is the subject of or being included in 15 clinical trials in Covid-19 listed on ClinicalTrials.gov.

Several other drugs with anti-inflammatory mechanisms of action are also being tested, such as monoclonal antibodies against IL-6 and even drugs like AstraZeneca’s Calquence (acalabrutinib), a BTK inhibitor used to treat lymphomas. These are distinct from direct-acting antivirals like Gilead Sciences’ remdesivir, which works by targeting the virus itself, or antivirals in development by companies like Regeneron Pharmaceuticals and Vir Biotechnology.

“While the approach to addressing Covid-19 continues to evolve, we’re pleased to partner with Lilly in this trial to assess [Olumiant’s] potential in the fight against Covid-19 and look forward to learning more about its impact on patients,” said study investigator Dr. Patrick Milligan, a physician at Community Health Network in Indianapolis, in a statement.

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Photo: Centers for Disease Control and Prevention