Kevzara is a fully-human monoclonal antibody, which inhibits the interleukin-6 (IL-6) pathway. The drug is being co-developed by Sanofi and Regeneron.
IL-6 is associated with the overactive inflammatory response in the lungs of severely or critically ill Covid-19 patients.
According to the companies, the trial will be initially performed at medical centres in New York, US.
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The multi-centre, double-blind, Phase II / III trial will compare the safety and efficacy of Kevzara in combination with usual supportive care, to placebo and supportive care combination.
With an adaptive design, the trial has two parts, enrolling up to 400 patients.
The first part will enrol severe Covid-19 patients in nearly 16 US sites. It will investigate the drug’s impact on fever and need for supplemental oxygen.
Meanwhile, the second, larger part will monitor longer-term outcomes, such as preventing death and mitigating the need for mechanical ventilation, supplemental oxygen or hospitalisation.
Regeneron Pharmaceuticals co-founder, president and chief scientific officer George Yancopoulos said: “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, randomised 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.”
Last week, Sanofi and Regeneron revealed plans to initiate trials of Kevzara for the treatment of Covid-19 symptoms.
To launch the trial quickly, the companies worked with the US Food and Drug Administration (FDA) and the Biomedical Advanced Research and Development Authority (BARDA).
Sanofi Research and Development global head John Reed said: “Scientific evidence has emerged to suggest that Kevzara may be a potentially important treatment option for critically-ill COVID-19 patients, and this trial will provide the well-controlled, rigorous scientific data we need to determine if IL-6 receptor inhibition with Kevzara is better than current supportive care alone.”
Reed also notes plans to launch trials outside the US, including most affected regions such as Italy, in the coming weeks.
Separately, Regeneron expanded alliance with BARDA for the development of Covid-19 treatments.
Sanofi vaccines division Sanofi Pasteur is also working with BARDA to assess pre-clinical SARS vaccine candidate for protection against Covid-19.