Sanofi and Regeneron Pharmaceuticals, Inc have begun patient treatment outside the United States as part of an evaluation of Kevzara (sarilumab) in patients hospitalized with severe cases of COVID-19.
The effort is part of Phase 2 and 3 trials in Italy, Spain, Germany, France, Canada, and Russia. It is a multi-center, double-blind trial that focuses on assessing the safety and efficacy of single intravenous doses of Kevzara for supportive care. Approximately 300 patients will be enrolled, all of them hospitalized with severe or critical COVID-19 infections.
“These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of COVID-19 infections by counteracting the overactive inflammatory responses in the lungs when damaged by the virus,” said Dr. John Reed, Sanofi’s Global Head of Research and Development. “In addition to this clinical trial aiming to help critically ill COVID-19 patients, our work continues to bring forth a vaccine for disease prevention, along with efforts to provide other important Sanofi medicines that may help patients impacted by COVID-19.”
Kevzara works by inhibiting the interleukin-6 (IL-6) pathway, binding and blocking the IL-6 receptor, which could, according to at least one Chinese study, drive the overactive inflammatory response that decimates in the lungs of those with the most severe cases of COVID-19.
“Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19,” said Dr. George Yancopoulos, co-founder, president and Chief Scientific Officer of Regeneron. “Despite this encouraging finding, it’s imperative to conduct a properly designed, randomized trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program. In addition to the Kevzara program, Regeneron continues to rapidly advance a novel antibody cocktail for the prevention and treatment of COVID-19.”
Sanofi is leading the tests abroad, while Regeneron conducts tests stateside. Patients will be studied for 60 days or until hospital discharge or death. At this time, Kevzara remains investigational — its potential has not been evaluated or approved by any regulatory authority.