Sanofi and Regeneron’s rheumatoid arthritis drug Kevzara (sarilumab) has failed to hit targets in a late-stage trial involving patients hospitalised with COVID-19, signalling the end of its development in this area.
The global Phase III trial assessing intravenously administered Kevzara at a dose of 200mg or 400mg in severely or critically ill patients hospitalised with COVID-19 did not meet its primary endpoint and key secondary endpoint when Kevzara was compared to placebo added to usual hospital care.
The findings follow the failure of a separate Phase III trial of Kevzara 400mg in COVID-19 patients requiring mechanical ventilation, which also did not meet primary and key secondary endpoints when the drug was added to best supportive care.
“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,” said John Reed, global head of Research and Development, Sanofi.
“In times like these, commitment to properly designed, controlled clinical trials, provides the information and understanding the scientific community needs for fact-based decision making.”
The firm said that while not statistically significant, “numerical trends were observed toward a decrease in duration of hospital stay as well as an acceleration in time to improve clinical outcomes”.
Also, a trend was observed towards reduced mortality in the critical patient group which was not seen in the severe patient group, and the time to discharge was shortened by two-three days in patients treated with Kevzara within the first two weeks of treatment.
However, given the disappointing findings Sanofi and Regeneron did say they do not anticipate conducting further clinical studies for Kevzara in COVID-19, and that more detailed results would be submitted to a peer-reviewed publication later this year.