Merck's investigational monoclonal antibody, Clesrovimab (MK-1654), has demonstrated significant efficacy in reducing respiratory syncytial virus (RSV) disease and related hospitalizations in healthy preterm and full-term infants. The findings, presented at IDWeek 2024, suggest Clesrovimab could be a vital preventive measure for infants during their first RSV season.
Phase 2b/3 Trial Results
The Phase 2b/3 trial, conducted across over 22 countries, involved healthy preterm and full-term infants. Results indicated that Clesrovimab led to a 60.4% reduction in RSV-associated medically attended lower respiratory infections. Furthermore, the antibody resulted in an 84.2% decrease in RSV-related hospitalizations, with severe cases of lower respiratory infections dropping by 91.7%.
Safety Profile
According to Anushua Sinha, MD, the safety profile of Clesrovimab was comparable to placebo. This is a crucial factor, suggesting that the antibody is well-tolerated in infants, making it a potentially safe option for widespread preventive use.
Clinical Implications
RSV is a common respiratory virus that can lead to severe illness in infants, particularly those born prematurely or with underlying health conditions. The significant reductions in RSV-associated infections and hospitalizations demonstrated by Clesrovimab highlight its potential to alleviate the burden of RSV on healthcare systems and improve infant health outcomes. The trial results suggest that Clesrovimab could offer a proactive strategy to protect infants during their vulnerable first RSV season.
