As the news keeps coming in fast and furious on the coronavirus pandemic, most of it upsetting, there is some positive news to report. BCW Member Regeneron today announced that it has already begun trials for a COVID-19 treatment. While it won’t happen overnight, it is comforting to know that a leader right here in Westchester and a member of the BCW is taking steps to combat the virus.
Regeneron announced that it has launched a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 infection. This U.S.-based trial will begin at medical centers in New York, and will assess the safety of adding Kevzara to usual supportive care. Kevzara, a fully-human monoclonal antibody, may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19.
The multi-center, double-blind, Phase 2/3 trial has two parts and is anticipated to enroll up to 400 patients. The first part will recruit patients with severe COVID-19 infection across approximately 16 U.S. sites, and will evaluate the impact of Kevzara on fever and patients’ need for supplemental oxygen. The second, larger part of the trial, will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization.
While it is difficult for most of us who do not specialize in this area to understand just how Kevzara® works, it is providing a ray of hope for those afflicted and their families. And those in the industry are marveling at the speed in which this is happening. George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron, explained how the trials will work.
“To initiate this trial quickly, so that the results may inform evidence-based treatment of this ongoing pandemic, Regeneron and Sanofi have worked closely with the U.S. Food and Drug Administration and the Biomedical Advanced Research and Development Authority, also known as the FDA and BARDA,” he 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. In addition to our Kevzara program, Regeneron is also rapidly advancing a novel antibody cocktail for the prevention and treatment of COVID-19, which we hope to have available for human testing this summer.”
We thank Regeneron and the clinical team working on these developments for giving us hope. We pray that the work of scientists like those at Regeneron will help us to put this dark chapter behind us. READ MORE ABOUT THE TRIAL.