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Sanofi, Regeneron launch trials of arthritis drug Kevzara for COVID-19

The interleukin-6 inhibitor will be evaluated in critically ill patients

Kevzara

Regeneron and Sanofi are the latest in a string of drugmakers looking to develop new, or evaluate existing, therapeutics for activity against the novel coronavirus disease COVID-19.

The two partners are set to begin a clinical programme evaluating the efficacy of Kevzara (sarilumab), an interleukin-6 inhibitor (IL-6), as a treatment for severely ill, hospitalised COVID-19 patients.

According to Regeneron, the IL-6 pathway could play a role in the overactive inflammatory response observed in the lungs of severely and critically ill COVID-19 patients.

The announcement comes close on the heels of China’s approval of Roche’s rival IL-6 inhibitor Actemra (tocilizumab) for the treatment of coronavirus patients with lung complications.

Prior research has suggested that high levels of IL-6 – a biomarker for inflammation and a high-level immune response – is associated with a higher mortality rate in people with community-acquired pneumonia.

Preliminary findings from a single-arm, 21-patient Chinese trial found that COVID-19 patients experienced rapidly reduced fevers, with 75% of patients experiencing a reduced need for supplemental oxygen, after treatment with Roche’s drug.

Encouraged and spurred on by the initial efficacy of Actemra, Kevzara’s owners are carrying out their own trials of the drug as a treatment for the novel coronavirus, with Regeneron overseeing the US trials, and all other trials lead by Sanofi.

The US-based trial is set to begin at medical centres in New York – one of the epicentres of the outbreak in the country.

Regeneron anticipates that the phase 2/3 trial will enrol up to 400 patients with the virus, with the first part of the study recruiting severely ill COVID-19 patients across 16 sites and evaluating the drug’s effect on fever and patients’ need for supplemental oxygen.

The second part of the study will be larger than the first, and will evaluate the improvement in longer-term outcomes including preventing death and reducing the need for mechanical ventilation, supplemental oxygen and/or hospitalisation.

"To initiate this trial quickly, so that the results may inform evidence-based treatment of this ongoing pandemic, Regeneron and Sanofi have worked closely with the US Food and Drug Administration and the Biomedical Advanced Research and Development Authority, also known as the FDA and BARDA," said George Yancopoulos.

As well as launching the Kevzara clinical programme, Regeneron is developing a ‘novel antibody cocktail’ for use against COVID-19  which it hopes to have available for human testing by the summer.

Sanofi is also already in partnership with BARDA for the fast-track development of a COVID-19 vaccine, based on its previous research into SARS, a disease which is caused by another type of coronavirus.

On Kevzara, the French drugmaker’s global head of research and development John Reed said the company plans to “rapidly initiate trials outside the US in the coming weeks, including areas most affected by the pandemic such as Italy”.

Article by
Lucy Parsons

16th March 2020

From: Research

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