Eli Lilly and Company announced Monday morning that a study conducted by the National Institute of Allergy and Infectious Diseases (NIAID) of hospitalized Covid-19 patients found that its rheumatoid arthritis drug baricitinib, in combination with Gilead’s antiviral drug remdesivir, reduces the median hospital stay of patients by one day compared to treatment with remdesivir alone.
Baractinib is an anti-inflammatory treatment for rheumatoid arthritis, an autoimmune disease. Its use as a potential treatment for severe cases of Covid-19, which is accompanied by severe lung inflammation, was first suggested by drug discovery company BenevolentAI in February. Baractinib is one of several drugs being tested by NIAID in combination with remdesivir, which a NIAID study published in May found reduces median hospitalization times by four days.
The Adaptive Covid-19 Treatment Trial (ACTT-2) began on May 8 and included over 1,000 patients in a double-blind, placebo-controlled study that compared patients who received a combination of remdesivir and baricitinib to patients who only received remdesivir. In addition to reducing hospitalization time (the primary goal of the study), the company reported positive patient outcomes of the combined treatments, but did not go into specifics.
“The investigators plan to conduct further analyses and post more detailed results as soon as possible,” NIAID said in a statement, adding that “a manuscript will be prepared and submitted to a peer-reviewed journal.”
Baricitinib, which the Indianapolis-based Lilly sells under the brand name Olumiant, is a rheumatoid arthritis treatment currently approved in over 70 countries, including the United States. The drug treats rheumatoid arthritis, an autoimmune disorder, by blocking particular signals that the body sends to the immune system. That in turn reduces the joint inflammation which can cause pain and mobility issues for arthritis sufferers.
In February 2020, drug discovery company BenevolentAI published a study in The Lancet suggesting that the anti-inflammatory effects of baricitinib might be an effective treatment for Covid-19, and so Lilly began to investigate the possibility. In severe cases of Covid-19, patients sometimes experience an inflammatory response called a “cytokine storm,” where their immune system goes into overdrive against the virus and inadvertently destroys lung tissue as well. The thinking behind using baricitinib, explains Lilly Bio-Medicines president Patrik Jonsson, is that its anti-inflammatory action reduces the cytokine storm, improving recovery time. Some preclinical work, he adds, also suggests baricitinib may have antiviral properties as well.
So what does this mean for Covid-19 patients? “Obviously, I want to see more data,” says Dr. Amesh Adalja, an infectious disease expert at Johns Hopkins University Center For Health Security. Adalja was not part of the study but did review the press release and notes that even though a reduction in hospital stays may not sound like much, “it is valuable in and of itself to get people out of the hospital quicker, especially because we worry so much about hospital capacity issues with this infection.”
As a result of the new study results, says Jonsson, Lilly plans on approaching the FDA for an emergency use authorization for baricitinib with Covid-19 patients, most likely in combination with remdesivir. “That would be most logical,” he says. “Particularly in hospitalized patients, but we’ll be guided by our discussions with them and with further analysis.”
In addition to its studies of baricitinib in combination with remdesivir, Lilly has also begun a phase 3 trial of baricitinib by itself for severe Covid-19 patients. That study, says Jonsson, will help the company refine applications for its drug against the pandemic. Overall, he says he’s optimistic based on results that have emerged so far.
“We’re excited to see this data,” he says. “We are doing whatever we can to fight Covid-19.”
Share prices in Lilly closed at $149 on Monday, up from the previous close of $148.14.