March 20, 2020
Regeneron and Sanofi have announced the initiation of a U.S. phase 2/3 trial evaluating anti-IL6 mAb Kevzara (sarilumab) in patients hospitalized with severe COVID-19 infection, to begin at medical centers in New York.
The adaptive design trial is expected to enroll up to 400 patients. The first part will evaluate the impact of Kevzara on fever and need for supplemental oxygen and the second part will evaluate the improvement in longer-term outcomes (preventing death, reducing the need for medical ventilation, supplemental oxygen and/or hospitalization).
Patients will be randomized 2:2:1 into Kevzara high dose, Kevzara low dose and placebo. The primary endpoint is reduction of fever and the secondary endpoint is decreased need for supplemental oxygen.
Trials outside the U.S. are expected to rapidly initiate, including in most affected areas such as Italy.
The restructuring of the Kevzara collaboration between the two companies is expected to be finalized in 1Q2020 as they continue to collaborate on COVID-19, with Regeneron leading U.S. work and Sanofi leading ex-U.S. work.
IL6 may play a role in driving the overactive inflammatory response in the lungs of COVID-19 patients and this is the first controlled U.S. trial to evaluate the effect of this cytokine inhibition.
This trial represents how drugs for autoimmune diseases may be beneficial in what has been declared a pandemic by the World Health Organization.
Secondly, it would provide Kevzara with momentum after having been unsuccessful in expanding the IL6 market in RA. Competitor IL6 inhibitor Actemra has had more reach than Kevzara beyond rheumatoid arthritis in other indications, including CAR-T cell induced cytokine release syndrome (CRS). Actemra was approved for coronavirus patients in China with CRS earlier in March, and is also being evaluated for its effect against the virus in a China clinical trial of approximately 200 patients.