Phase III trial into nirsevimab for RSV treatment yields positive results
pharmafile | March 4, 2022 | News story | Medical Communications |
The latest results from Sanofi and AstraZeneca’s Phase III trial nirsevimab support the vaccine’s ability to protect all infants from the respiratory syncytial virus (RSV) with a single dose.
The Phase III MELODY trial analysed healthy infants born at term or late preterm (at east 35 weeks), and researchers found a 74.5% lower incidence of RSV-caused pneumonia, bronchiolitis, and other medically attended lower respiratory tract infections compared to those who were given a placebo. The research found that, in infants older than 28 weeks at the same dose, there was a 77.3% lower incidence of RSV-linked hospitalisations.
MELODY is a randomised, placebo-controlled study conducted among healthy infants entering their first RSV season in 21 countries.
Nirsevimab is an investigational long-acting antibody, designed to work to protect all infants in their first RSV season. The vaccine aims to give direct and rapid protection through a single immunisation dose. RSV is the most common cause of lower respiratory tract infection, and is a leading of infant hospitalisations.
“With three pivotal late-stage trials, our research has been focused on delivering a first-in-class RSV prevention for all infants. Our Phase III MELODY results in healthy late preterm and term infants represent a major milestone toward that goal. We are pleased that nirsevimab has the potential to become the first immunization to protect all infants across the RSV season, with only a single dose,” commented Jean-François Toussaint, the global head of research and development vaccines at Sanofi.
“Respiratory syncytial virus is a leading cause of lower respiratory tract infections, such as bronchiolitis or pneumonia, as well as hospitalizations in infants,” said Mene Pangalos, the executive vice president for biopharmaceuticals R&D at AstraZeneca. “These data show for the first time, the potential to significantly protect all infants through their first RSV season with a single-dose immunization and we look forward to working with health authorities to bring nirsevimab to infants as quickly as possible.”
