Sanofi’s RSV drug sees Phase III clinical trial success

pharmafile | April 26, 2021 | News story | Sales and Marketing AstraZeneca, Sanofi 

Sanofi have announced positive topline results from the Phase III MELODY trial into nirsevimab, which demonstrated protection against respiratory syncytial virus (RSV) disease in healthy infants.

The data show nirsevimab reduced lower respiratory tract infections (LRTI) requiring medical attention (inpatient or outpatient) due to respiratory syncytial virus in healthy preterm and term infants.

Nirsevimab reached its primary endpoint, achieving a statistically significant absolute reduction of LRTI caused by RSV in healthy preterm and term infants, compared to placebo through a typical RSV season.

Primary investigator for the MELODY trial, Dr William Muller, Associate Professor, Pediatrics, Northwestern University Feinberg School of Medicine and Scientific Director, Clinical and Community Trials at Ann & Robert H. Lurie Children’s Hospital of Chicago, said: “Despite respiratory syncytial virus being the leading cause of pneumonia and bronchiolitis in the first year of life, there is no routine preventative option currently approved for all infants.

“These exciting trial data demonstrate the potential for nirsevimab to change the prevention landscape not only by providing protection to a broad population of infants across the full respiratory syncytial virus season, but also by achieving this with a single dose.”

RSV is a common, contagious virus that infects the respiratory tract, causing millions of hospitalisations globally in infants, and is the most common cause of bronchiolitis and pneumonia in children younger than one year.

Hospitalisation rates due to RSV infection are consistently highest in the first year of life – with infants under one year representing 75% of RSV hospitalisations in children under five years.

Nirsevimab is being developed in partnership with AstraZeneca and is the first investigational extended half-life monoclonal antibody aiming to protect all infants entering their first RSV season, when they are at highest risk for severe RSV disease.

With nirsevimab, a protective antibody is administered directly to the infant with the goal of providing rapid protection, in contrast to other options for RSV under development, such as maternal vaccines.

Mene Pangalos, Executive Vice President of BioPharmaceuticals R&D at AstraZeneca, said: “These ground-breaking results mark a major scientific advancement in our effort to provide protection against respiratory syncytial virus for all infants. Nearly all children will contract the virus before age two, leading to nearly 30 million acute lower respiratory tract infections globally each year.

“Nirsevimab has the potential to provide a significant public health benefit as the first respiratory syncytial virus immunisation for the general infant population, and these data bring us one step closer to delivering nirsevimab to infants worldwide.”

Kat Jenkins

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