The companies initiated a Phase II/III trial in Italy, Spain, Germany, France, Japan, Canada and Russia.
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.
