Regeneron has started a drug trial to see whether the drug Kevzara that it developed with the French multinational pharmaceutical company Sanofi and has been approved to treat patients with rheumatoid arthritis also works to treat the inflammatory effects of the virus COVID-19.
The coronavirus attacks the lungs and causes inflammation, resulting in a diminished ability to breathe. It has been theorized that Kevzara (sarilumab) might inhibit lung inflammation in COVID-19 in the same way it inhibits inflammation in arthritis patients.
Kevzara is a monoclonal antibody drug that binds to and blocks the interleukin-6 (IL-6) protein signaling pathway that has been associated with rheumatoid arthritis. IL-6 helps regulate immune responses and inflammation among other functions.
In a Chinese study, when the protein in 21 patients who had COVID-19 was blocked using a different IL-6 receptor antibody, their fevers rapidly declined and the supplemental oxygen that 15 of them had been receiving was able to be reduced.
Westchester-based Regeneron said that if its clinical trial goes all the way to completion about 400 patients will have been enrolled. To enter the U.S. trial, patients must be hospitalized with laboratory-confirmed COVID-19 that is classified as severe or critical.
George D. Yancopoulos, co-founder, president and chief scientific officer of Regeneron, said, “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. Despite this encouraging finding, it’s imperative to conduct a properly designed, randomized trial to understand the true impact. Our trial is the first controlled trial in the U.S. to evaluate the effect of IL-6 inhibition prospectively in COVID-19 patients.”
At the same time, Regeneron has been making progress in its efforts to create a cocktail of monoclonal antibodies that will provide immunity against the novel coronavirus and provide those who already have the virus some ready-made antibodies for their body to use in fighting it.
Regeneron has announced that its scientists have isolated hundreds of antibodies created in mice that might have a possibility of fighting COVID-19. The mice were re-engineered so their immune systems emulate the immune systems of humans. It also has isolated antibodies from humans who have recovered from COVID-19.
Regeneron plans to find the two antibodies that have the greatest ability to bind to so-called spike proteins on the surface of the virus and thus block them from infiltrating human cells.
The company said that using a multi-antibody approach allows for targeting of different parts of the virus and may help protect when and if the virus goes through changes similar to the way new strains of influenza appear from year to year.
The company said that as the lead antibodies are selected it plans to immediately begin clinical-scale production and hopes to have the quantities necessary for clinical trials by the beginning of summer. Its goal would be to produce hundreds of thousands of doses per month by the end of summer.