CPhI Online

- Research & Development

Regeneron and Sanofi begin global Kevzara clinical trial program in patients with severe COVID-19

16 Mar 2020

The trial is the first controlled trial in the US to evaluate the effect of IL-6 inhibition prospectively in COVID-19 patients.

Regeneron Pharmaceuticals and Sanofi have started a clinical program evaluating Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection.

Kevzara is a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor. 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.

This US-based trial will begin at medical centers in New York, one of the epicenters of the US COVID-19 outbreak, and will assess the safety and efficacy of adding Kevzara to usual supportive care, compared with supportive care plus placebo.

The multi-center, double-blind, Phase II/III trial has an adaptive design with 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 US 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.

The two companies have worked closely with the US Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA) to initiate the trial quickly, so that the results may inform evidence-based treatment of this ongoing pandemic.

George D. Yancopoulos, Co-founder, President and Chief Scientific Officer of Regeneron explained: "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 US to evaluate the effect of IL-6 inhibition prospectively in COVID-19 patients.

Regeneron is also rapidly advancing a novel antibody cocktail for the prevention and treatment of COVID-19, which the company hopes to have available for human testing this summer.