Benzinga | Jun 28, 2021 08:33AM EDT

AstraZeneca's Nirsevimab Shows Favorable Safety, Tolerability Profile In Infants At High Risk Of RSV

* AstraZeneca Plc (NASDAQ:AZN) announced data from the MEDLEY Phase 2/3 trial evaluating nirsevimab in infants at high risk of respiratory syncytial virus (RSV).

* The trial assessed the safety and tolerability of nirsevimab compared to Sobi's Synagis (palivizumab) in infants with chronic lung disease, congenital heart disease, and/or prematurity.

* RSV is a common, contagious pathogen that causes seasonal epidemics of lower respiratory tract infections (LRTI), including bronchiolitis and pneumonia.

* Nirsevimab, being developed by AstraZeneca and Sanofi SA (NASDAQ: SNY), showed a safety and tolerability profile comparable to the only available preventative option against lower respiratory tract infections (LRTI) caused by RSV, with one dose for the entire season.

* The occurrence of treatment-emergent adverse events or treatment-emergent serious adverse events was similar between groups.

* Full results from the MEDLEY trial will be presented at a forthcoming medical meeting. The trial is ongoing to collect additional safety data.

* Nirsevimab is also being evaluated in the MELODY Phase 3 trial, which met its primary endpoint of a statistically significant reduction in the incidence of medically attended LRTI caused by RSV compared to placebo healthy late preterm and term infants.

* The company plans regulatory submissions from the first half of 2022.

* Price Action: AZN shares are up 0.62% at $59.72 during the premarket session on the last check Monday.