The drug under examination is Kevzara (sarilumab), a fully-human monoclonal antibody that inhibits the interleukin-6 (IL-6) pathway by binding and blocking the IL-6 receptor.
Kevzara was developed under a collaboration between Regeneron and Sanofi; it was approved in 2017 as a treatment for rheumatoid arthritis.
Developers believe that IL-6 may play a role in the overactive inflammatory response in the lungs of patients who are ill with the coronavirus disease.
Clinical trials will recruit patients hospitalized with severe coronavirus infection, and it is anticipated to include up to 400 participants.
The trials will begin at medical centers in New York, which is considered one of the epicenters of the outbreak in the US, and will expand across 16 sites in the country.
During a second stage of the trials, researchers will evaluate patients’ improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization.
The expectations for the clinical development project are supported by data from clinical research in China, where patients experienced reduced fevers and need for supplemental oxygen within days of receiving tocilizumab, another IL-6 receptor antibody.
Following these results, China included the use of that IL-6 inhibitor in its treatment guidelines to fight the pandemic.
Concurrently with testing the effectiveness of Kevzara against coronavirus, Regeneron is developing a ‘multi-antibody cocktail’ that could be administered either as a treatment or as prophylaxis before exposure to the coronavirus.
The company said it anticipates taking this development project into human clinical studies by early summer.
