Sanofi and Regeneron Pharmaceuticals announced Monday that they have initiated a clinical programme evaluating whether IL-6 inhibition with Kevzara (sarilumab) is better than current supportive care alone for patients hospitalised with severe COVID-19. A Phase II/III study in the US led by Regeneron will begin enrolling patients immediately, while Sanofi's global R&D chief John Reed said "we expect to rapidly initiate trials outside the US in the coming weeks, including areas most affected by the pandemic, such as Italy."
The companies noted that the US trial is expected to enroll up to 400 adults, recruited across approximately 16 sites, who are hospitalised with laboratory-confirmed COVID-19 classified as severe or critical, or who are suffering from multi-organ dysfunction. After receiving the study dose, patients will be assessed for 60 days, or until hospital discharge or death.
Specifically, in the Phase II part of the study, participants will be randomised to receive a low or high dose of Kevzara or placebo. The primary endpoint is reduction of fever, while the secondary goal is decreased need for supplemental oxygen. Findings from the initial part of the study will determine the design of the larger Phase III portion of the trial, which will look at longer-term outcomes, including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalisation.
The drugmakers noted that "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," citing preliminary data from a 21-patient Chinese study that used Roche's IL-6 receptor antibody Actemra (tocilizumab). According to Sanofi and Regeneron, non-peer-reviewed results from that study showed that fevers rapidly declined, while 75% of patients had a reduced need for supplemental oxygen within days of receiving Actemra. The findings prompted Chinese officials to update their treatment guidelines and approve Actemra to treat patients with severe or critical disease.
Kevzara, which is approved to treat patients with moderately to severely active rheumatoid arthritis, was jointly developed by Sanofi and Regeneron under a global collaboration agreement signed in 2007. This past December, they announced their intent to restructure the joint alliance in a move expected to be finalised in the first quarter of 2020.
Besides Kevzara, Sanofi's global vaccines business is also working with the US Biomedical Advanced Research and Development Authority to develop a vaccine against the coronavirus infection by leveraging previous research that had been conducted for a SARS vaccine. Meanwhile, Regeneron chief scientific officer George Yancopoulos noted that his company is "also rapidly advancing a novel antibody cocktail for the prevention and treatment of COVID-19, which we hope to have available for human testing this summer." He credited Regeneron's end-to-end antibody discovery, development and manufacturing technologies, including its VelocImmune human antibody mouse, as helping to "expedite a typically years-long process into a matter of months."
In February, Regeneron expanded a collaboration with the US Department of Health and Human Services to develop antibody treatments against COVID-19, with CEO Leonard Schleifer recently suggesting his company hopes to have its treatment produced and ready for clinical testing possibly by August.
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