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Sanofi has reported that the Phase III clinical trial of Kevzara (sarilumab) performed outside the US failed to meet the primary and key secondary endpoints in Covid-19 patients.
The trial compared a 200mg and 400mg dose of the drug to placebo when added to the usual hospital care in a total of 420 severely or critically ill hospitalised patients with Covid-19.
It involved sites across Argentina, Brazil, Canada, Chile, France, Germany, Israel, Italy, Japan, Russia and Spain.
Data from the ex-US trial showed numerical trends towards a reduction in the duration of hospital stay and an acceleration in time to clinical outcomes improvement, but these trends were not statistically significant.
Sanofi also reported a trend towards decreased mortality in the critical patient group, which was not observed in severely ill patients.
In addition, the time to discharge was shortened by two to three days in the patients on Kevzara within the first two weeks of treatment.
Serious adverse events were found in 26% to 29% of Kevzara patients and 24% on placebo.
Sanofi Research and Development global head John Reed said: “Although this trial did not yield the results we hoped for, we are proud of the work that was achieved by the team to further our understanding of the potential use of Kevzara for the treatment of Covid-19.
“At Sanofi, we are committed to help combat the global Covid-19 pandemic, including developing vaccine candidates that can be manufactured at large-scale.”
Kevzara is designed to specifically bind to the IL-6 receptor and inhibit IL-6 mediated signalling. The drug is currently indicated in several countries to treat adults with moderately to severely active rheumatoid arthritis.
In July this year, Sanofi and Regeneron Pharmaceuticals have reported that a Phase III trial of Kevzara failed to meet its primary and key secondary endpoints in Covid-19 patients who required mechanical ventilation in the US.