Clinical Study for Severe COVID-19 Antibody Medication Launches
A phase 2/3 clinical trial has been initiated and will begin enrolling patients immediately, announced Regeneron Pharmaceuticals, Inc. and Sanofi.
Announced on March 16, 2020, these companies said they started a clinical program evaluating Kevzara® (sarilumab) in patients hospitalized with severe COVID-19 disease infection.
However, the use of Kevzara to treat the symptoms of COVID-19 is investigational and has not been fully evaluated by any regulatory authority.
Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor.
This announcement says IL-6 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 role of IL-6 is supported by preliminary data from a single-arm study in China, using another IL-6 receptor antibody.
This U.S.-based clinical trial will begin at medical centers in New York and will assess the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo.
The multi-center, double-blind, Phase 2/3 trial has an adaptive design with two parts and is anticipated to enroll up to 400 patients.
The 1st 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 2nd, 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.
"To initiate this trial quickly, so that the results may inform the 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," said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron.
"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.”
“This technology was applied to the Ebola virus, where our therapy, REGN-EB3, was shown to dramatically improve survival in infected patients last year,” concluded Dr. Yancopoulos.
Kevzara was jointly developed by Regeneron and Sanofi under a global collaboration agreement.
Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases.
Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health.
SARS-CoV-2 outbreak news is published by Coronavirus Today.com.
COVID-19 medication development news published by Precision Vaccinations.