Sanofi, Regeneron Begin Clinical Trial for Antiviral Kevzara for Coronavirus
Sanofi and Regeneron Pharmaceuticals, Inc., a Tarrytown, New York-based biopharmaceutical company, have started a clinical program evaluating Kevzara (sarilumab), an antiviral compound, in patients hospitalized with severe COVID-19 (the novel coronavirus).
Jointly developed by both companies, 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 infection, according to information from the companies. The role of IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.
The US-based trial will begin at medical centers in New York, one of the epicenters of the COVID-19 outbreak in the US, 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 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 and 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.
In late 2019, Regeneron and Sanofi announced their intent to simplify the joint collaboration for Kevzara, which is expected to be finalized in the first-quarter of 2020. The companies will continue to collaborate on COVID-19 and other related acute respiratory distress syndrome (ARDS) development, with Regeneron leading US-based work and Sanofi leading work outside of the US.