Sanofi and Regeneron Pharmaceuticals, Inc. announced that the U.S. Phase 3 trial of arthritis drug Kevzara (sarilumab) 400 mg in COVID-19 patients requiring mechanical ventilation did not meet its primary and key secondary endpoints.
In the trial, Kevzara was added to best supportive care compared to best supportive care alone (placebo).
Based on the disappointing results, the companies have stopped the U.S. trial, including in a second cohort of patients who received a higher dose of Kevzara (800 mg).
Meanwhile, a separate Sanofi-led trial outside of the U.S. in hospitalized patients with severe and critical COVID-19 using a different dosing regimen is ongoing. The Independent Data Monitoring Committee, which is overseeing both the Regeneron-led U.S. trial and the Sanofi-led trial outside of U.S., has recommended that the trial outside of the U.S. continue.
The companies expect to report results in the third quarter.
Kevzara, jointly developed by Sanofi and Regeneron, is an approved drug for rheumatoid arthritis and it is being tested for COVID-19 treatment. The latest trial was based on data from a single-arm study in China suggesting that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19. Kevzara is also an interleukin-6 (IL-6) receptor antagonist.
It was in mid-March that Sanofi and Regeneron initiated the clinical program evaluating Kevzara in Covid-19 patients.
In the U.S. trial, the primary analysis group included 194 patients who were critically ill with COVID-19 and receiving mechanical ventilation at the time of enrolment.
Sanofi and Regeneron noted that in the trial, minor positive trends were observed in the primary pre-specified analysis group that did not reach statistical significance. These were countered by negative trends in a subgroup of critical patients who were not mechanically ventilated at baseline.
In the primary analysis group, adverse events were experienced by 80% of Kevzara patients and 77% of placebo patients.
Source: Read Full Article