Sanofi/Regeneron Drug in Trials for Treatment of Severe COVID-19

Sanofi and Regeneron have begun a second Phase 2/3 trial for Kevzara (sarilumab) in COVID-19 patients in Italy, Spain, Germany, France, Canada and Russia following initiation of the first trial in the US. Sanofi is leading the trials outside the US, with Regeneron leading the US trials.

Jointly developed by Sanofi and Regeneron under a global collaboration agreement, Kevzara is a fully-human monoclonal antibody currently approved in multiple countries for treatment of rheumatoid arthritis. Kevzara binds specifically to the IL-6 receptor and has been shown to inhibit IL-6-mediated signaling. IL-6 is an immune system protein produced in increased quantities in patients with rheumatoid arthritis and has been associated with disease activity, joint destruction and other systemic problems.

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 infection. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor inhibitor.

“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. 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,” said George D. Yancopoulos, M.D., Ph.D., Co-founder, President and Chief Scientific Officer of Regeneron.

The trial outside of the US will assess the safety and efficacy of adding a single intravenous dose of Kevzara to usual supportive care, compared to supportive care plus placebo. The trial has an adaptive design with two parts and is anticipated to enroll approximately 300 patients. The trial will recruit hospitalized patients from several countries who are severely or critically ill with COVID-19 infection.

The use of Kevzara to treat the symptoms of COVID-19 is investigational and has not been evaluated by any regulatory authority. (Source: Sanofi Genzyme Website, 30 March, 2020)