Trial Testing Arthritis Drug as Covid-19 Treatment

(CDC.gov)

16 Mar. 2020. A clinical trial is enrolling patients with severe novel coronavirus infections to test a synthetic antibody now approved to treat rheumatoid arthritis. The trial is conducted by biotechnology company Regeneron Pharmaceuticals Inc. in Tarrytown, New York and drug maker Sanofi in Paris, developers of sarilumab, a synthetic antibody marketed under the brand name Kevzara.

Regeneron and Sanofi are assessing sarilumab to find treatments among currently available drugs for the rapidly spreading novel coronavirus or Covid-19 pandemic. A global case tracking dashboard hosted by Johns Hopkins University says as of today (16 March), more than 179,000 cases are reported in 155 geographic regions, leading to more than 7,000 deaths. In the U.S., 4,138 Covid-19 cases are confirmed, with 70 deaths attributed to the disease.

Sarilumab treats rheumatoid arthritis, an autoimmune disease, where the immune system is tricked into attacking healthy cells, that leads to inflammation of joints — wrists, fingers, feet, and ankles — and surrounding tissue. The synthetic antibody inhibits a protein called interleukin 6, or IL-6, associated with chronic inflammation and autoimmunity. Regeneron and Sanofi believe sarilumab may help patients with acute respiratory distress syndrome, a severe form of Covid-19 infections, reduce similar inflammation in their lungs.

Early results from a small clinical study in China shows another drug blocking IL-6, tocilizumab, helps treat patients with acute respiratory distress syndrome. The findings, not yet, peer-reviewed, show patients given tocilizumab quickly reduce fevers, and in three-quarters of the 21 cases, reduce the need for supplemental oxygen within days.

The companies’ new mid- and late-stage clinical trial uses an adaptive design that enables the study team to adjust the trial protocols as results come in. The study will first assess the safety and efficacy of sarilumab in patients with severe infections, including pneumonia, fever, or organ dysfunction. Participants will be randomly assigned to receive a high or low dose of sarilumab, or a placebo, and be monitored for 60 days, looking primarily for changes in fever and the need for supplemental oxygen.

As dictated by the early trial results, the researchers will shift into more of a long-term assessment, tracking the need among participants for mechanical ventilation, supplemental oxygen, hospitalization, and prevention of death. If needed, the study team will enroll as many as 400 patients at 16 sites. The companies say they worked with Food and Drug Administration and the Biomedical Advanced Research and Development Authority to get the trial underway.

“Data from China suggest that the IL-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with Covid-19,” says George Yancopoulos, co-founder and chief scientist at Regeneron, in a company statement. Despite this encouraging finding, it’s imperative to conduct a properly designed, randomized trial to understand the true impact.”

Yancopoulos adds that Regeneron is also “advancing a novel antibody cocktail for the prevention and treatment of Covid-19, which we hope to have available for human testing this summer.”

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