Sanofi begins trial of Kevzara against COVID-19 complications
Sanofi and Regeneron are throwing an already-approved drug at COVID-19, testing Kevzara (sarilumab) in patients hospitalised with severe disease.
The thinking behind this trial is similar to that behind using Roche’s rival IL-6 drug against COVID – evidence suggests that overproduction of this chemical messenger is one of the causes for the inflammation seen in patients who are severely ill with the disease.
Too much IL-6 causes the immune system to begin attacking the patient’s own body instead of the virus and Kevzara, previously approved in rheumatoid arthritis, could be a way of treating the severe symptoms that cause complications seen with COVID-19.
The role of IL-6 is supported by preliminary data from a single-arm study in China using Actemra (tocilizumab).
Sanofi is leading trials outside of the US, while its development partner Regeneron is dealing with trials within the US.
The global clinical programme has now been initiated in Italy, Spain, Germany, France, Canada, Russia and the United States – all countries that have been impacted by COVID-19.
This is the second multi-centre, double-blind, phase 2/3 trial as part of the Kevzara COVID-19 programme, and the companies are continuing to work with health authorities around the world to secure initiation at additional sites.
This follows Sanofi and Regeneron’s announcement earlier this month of the initiation of the first trial, which is US based.
At the beginning of the month Chinese authorities issued guidelines recommending Actemra as a way to combat the severe complications caused by COVID-19.
Roche has since begun its own trial of Actemra in COVID-19 that could lead to approval in other countries if results are supportive.
With no approved therapies for COVID-19, the FDA has allowed chloroquine and hydroxychloroquine to be used in teens and adults with severe COVID-19 under emergency measures, even though there is scant clinical trial evidence to back its efficacy and concerns over its safety.