Can a medicine approved for rheumatoid arthritis treat patients with COVID-19? Eli Lilly wants to find out.
The Indianapolis-based drugmaker has entered into an agreement with the National Institute of Allergy and Infectious Diseases to study its popular drug baricitinib in a trial to investigate its safety and effectiveness for hospitalized patients diagnosed with COVID-19.
Baricitinib, also known under the brand name Olumiant, is approved in more than 65 countries as a treatment for adults with moderately to severely active rheumatoid arthritis. It has been used by more than 100,000 patients.
Right now, baricitinib is a fairly restricted drug in the United States due to its safety profile. The Food and Drug Administration approved it in 2018, but cited safety risks of infections, malignancies and blood clotting. It said Lilly could only sell a low-dose version, reducing the number of patients eligible for the treatment. And the drug was slapped with a black box warning, the strictest labeling of prescription drugs.
Nevertheless, Lilly wants to see if the drug might be useful for COVID-19, a disease often marked by respiratory distress, coughing and sore throat. At the same time, dozens of other drugmakers and biotechs have begun racing to try to find a treatment or cure.
Patrik Jonsson, Lilly’s president of Bio-Medicines, said the idea to test baricitinib started in February when officials with an artificial intelligence platform based in the United Kingdom and unaffiliated with Lilly wrote a letter to the British medical journal Lancet, saying they planned to assess many currently approved medications that might be used in treating COVID-19.
Currently, there are no treatments for the disease, which has claimed more than 177,000 lives worldwide, including more than 22,000 in the U.S.
“They used artificial intelligence to review the literature and understand if it could be any already approved medication that could be used to treat the COVID-19,” Jonsson said.
A few weeks later, the same group submitted a new letter to Lancet in which they said they specified an interest in baricitinib, saying the medicine’s anti-inflammatory effects might be beneficial in treating COVID-19.
Since then, various groups have conducted preclinical studies on baricitinib, and independent investigators also initiated small-scale trials in Italy and Canada, but they have not been placebo-controlled.
All these together has led Lilly to the decision that the drug should be studied further for possible benefits in treating COVID-19, and it initiated discussions with the National Institute of Allergies and Infectious Diseases.
“And that’s why we are extremely, extremely excited, and of course, curious to see for ourselves,” Jonsson said.
The trials, involving hundreds of patients, will start soon in the U.S. and expand later to Europe and Asia. Lilly hopes to get trial results by June to see whether the drug worked against the symptoms of COVID-19 and is relatively safe.
Lilly’s hypothesis is that baricitinib can be used to inhibit a protein involved in the viral reproduction of the virus.
“We are doing everything we possibly can, committing all resources needed to rapidly find an answer,” Jonsson said.