Merck’s Investigational RSV Antibody, Clesrovimab, Meets Primary Safety and Efficacy Endpoints in Phase 2b/3 Trial for Infant Prevention

1. Positive Topline Results: Merck's Phase 2b/3 trial of clesrovimab (MK-1654) met all primary safety and efficacy endpoints, reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150.
2. RSV Prevention: The investigational monoclonal antibody aims to protect healthy preterm and full-term infants from RSV disease, which is a leading cause of hospitalization for healthy infants under a year old.
3. Trial Design: The double-blind, randomized, placebo-controlled study evaluated the safety and efficacy of clesrovimab in infants, with primary endpoints including the incidence of RSV-associated MALRI and safety measures such as injection-related adverse events and serious adverse events.
4. Global Impact: RSV is a widespread seasonal infection causing an estimated 101,000 deaths a year worldwide in children under five, highlighting the need for preventative options.
5. Regulatory Plans: Merck plans to file the data with global regulatory authorities, paving the way for potential approval and availability of clesrovimab for infant protection.