Sanofi (EPA: SAN) and Regeneron Pharma (NSDQ: REGN) of New York State have started clinical trials of Kevzara® (sarilumab) in patients hospitalized with severe COVID-19. Kevzara, a fully-human mAb that inhibits the IL-6 receptor, has been approved since 2017 in the US and EU as a treatment for rheumatoid arthritis. In COVID-19 patients, the drug is aimed at inhibiting the overwhelming inflammatory response in the lungs of patients with serious disease. Sanofi also plans to start trials of Kevzara outside the US in the near future.

Sanofi and Regeneron developed the drug jointly, but in Q4 of 2019, Sanofi announced plans to take global control of Kevzara while Regeneron will receive royalties on sales.

Sanofi and Regeneron decided to start the trial after another IL-6 receptor antibody (tocilizumab) was effective in COVID-19 patients. Tocilizumab lowered fevers and reduced the need for supplemental oxygen in 75% of patients (15 out of 20) (the results were not peer-reviewed). Based on the results, China updated its COVID-19 treatment guidelines to include tocilizumab) as a treatment in patients with severe or critical disease.

This US-based trials will begin at medical centers in New York. They will assess the safety and efficacy of adding Kevzara to usual supportive care, compared to supportive care plus placebo. The multi-center, double-blind, Phase II/III trial is expected to enroll up to 400 patients,

The first part of the trial will recruit patients with severe COVID-19 infection in 16 US. sites. It will evaluate the impact of Kevzara on fever and patients' need for supplemental oxygen. The second, larger part of the trial will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalization.

Regeneron also announced that it expects to have a novel antibody cocktail for the prevention and treatment of COVID-19 ready for human tests by this summer. It said both programs were developed by its own antibody discovery, development and manufacturing technologies, starting with its proprietary VelocImmune human antibody mouse platform. It used the same technology to develop an Ebola virus candidate, which was shown to increase survival in infected patients last year

"At Sanofi, we are taking a leading role in addressing the global challenge of COVID-19 disease. We believe that there is scientific evidence to suggest that Kevzara may be a potentially important treatment option for some patients, and this trial will provide the well-controlled, rigorous scientific data we need to determine if IL-6 inhibition with Kevzara is better than current supportive care alone. Additionally, we expect to rapidly initiate trials outside the US in the coming weeks, including areas most affected by the pandemic such as Italy," said John Reed, MD, PhD, Sanofi's Global Head of Research and Development. "In addition to Kevzara, Sanofi Pasteur, the vaccines global business unit of Sanofi, is leveraging previous development work for a SARS vaccine as part of our goal to quickly develop a COVID-19 vaccine."

"To initiate this trial quickly, Regeneron and Sanofi have worked closely with the US Food and Drug Administration and the Biomedical Advanced Research and Development Authority, otherwise known as the FDA and BARDA ," said George D. Yancopoulos, MD, PhD, Co-founder, President and CSO of Regeneron. "Our trial is the first controlled trial in the US to evaluate the effect of IL-6 inhibition prospectively in COVID-19 patients. In addition to our Kevzara program."

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Disclosure: none.