Merck (MRK) announced the presentation of positive results from the Phase 2b/3 clinical trial evaluating clesrovimab, the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus disease during their first RSV season. The results, along with interim findings from the ongoing Phase 3 trial of clesrovimab, were presented during IDWeek 2024, held October 16-19 in Los Angeles, California. Results from MK-1654-004, a placebo-controlled Phase 2b/3 pivotal trial evaluating a single dose of clesrovimab administered to healthy preterm and full-term infants (birth to 1 year of age) met all prespecified endpoints, with consistent results through both the 5-month and 6-month time points. The incidence of adverse events and serious AEs were comparable between the clesrovimab and placebo groups, and there were no treatment or RSV-related deaths during the study.
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