Sanofi and Regeneron Launch Second Kevzara Trial Against COVID-19

Vaccine Clinical Trial

Regeneron and Sanofi dosed the first patient outside of the United States with the rheumatoid arthritis drug Kevzara as part of a second global clinical trial assessing the medication as a treatment for COVID-19, the disease caused by the novel coronavirus pandemic.

The companies initiated a Phase II/III trial in Italy, Spain, Germany, France, Japan, Canada and Russia. The belief is that Kevzara, an inhibitor of IL-6, could calm an overactive immune response against the lungs and other organs seen in some severe COVID-19 patients. The idea is that Kevzara may calm that immune response in these patients, IL-6 may play a role in driving the overactive inflammatory response in the lungs of patients who are severely or critically ill with COVID-19 infection. The companies began testing Kevzara following anecdotal reports from China that patients treated with Roche’s Actemra, also an IL-6 inhibitor, showed efficacy in treating these patients.

“Data from a single-arm study in China suggest that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19. Despite this encouraging finding, it's imperative to conduct a properly designed, randomized trial to understand the true impact of Kevzara, which we are now doing through this global clinical trial program,” George D. Yancopoulos, co-founder, president and chief scientific officer of Regeneron said in a statement.

The European trial is designed to evaluate the safety and efficacy of Kevzara in adults hospitalized with serious complications from COVID-19. The trial is expected to enroll approximately 300 patients, depending on the status of the COVID-19 outbreak and the proportion of patients with severe COVID-19. After receiving the study dose, patients will be assessed for 60 days, or until hospital discharge or death. The European trial is the second Kevzara trial initiated against COVID-19 by the two companies. Earlier this month Regeneron and Sanofi initiated a trial in the United States.

"Sanofi and Regeneron are relentlessly working to rapidly initiate trials around the world that will help determine whether Kevzara has the potential to play a role in addressing the COVID-19 disease global health crisis. These trials will provide important data to determine whether Kevzara ameliorates the life-threatening complications of COVID-19 infections by counteracting the overactive inflammatory immune responses in the lungs when damaged by the virus,” John Reed, Sanofi’s global head of research and development said in a statement.

In addition to studying Kevzara, Regeneron is also advancing an antibody program against COVID-19. In March, Regeneron said it identified hundreds of virus-neutralizing antibodies and intends to begin large-scale manufacturing by mid-April. As BioSpace previously reported, the antibody cocktail therapy is expected to be administered as prophylaxis before exposure to the SARS-CoV-2 virus or as a treatment for those already infected.

On its own, Sanofi is attempting to develop a vaccine for COVID-19. The company has teamed up with Translate Bio to develop a novel messenger RNA vaccine against the virus and is also working with the Biomedical Advanced Research and Development Authority (BARDA) to advance a novel COVID-19 vaccine candidate. That agreement calls for Sanofi to initiate the development of a recombinant, protein-based vaccine candidate against COVID-19.

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