Therapy Areas: Inflammatory Diseases
Regeneron partners with Sanofi to launch global Kevzara clinical trial programme for COVID-19
18 March 2020 -

Biotechnology company Regeneron Pharmaceuticals Inc (NASDAQ:REGN) stated on Tuesday that it has started a clinical programme to evaluate Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection in partnership with Sanofi.

According to the company, 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 critically ill with COVID-19. It is being investigated for its ability to reduce the overactive inflammatory immune response associated with COVID-19.

The company added that IL-6 is supported by preliminary data from a single-arm study in China using another IL-6 receptor antibody.

This US based trial will begin at medical centres 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 to supportive care plus placebo. The multi-centre, double-blind, Phase 2/3 trial has an adaptive design with two parts and is anticipated to enroll up to 400 patients.

In conjunction, the first part will recruit patients with severe COVID-19 infection across 16 US sites to 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, concluded the partnership.

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