Merck's Clesrovimab Lowers RSV Disease And Hospitalization In Preterm And Full-term Infants

(RTTNews) - Merck & Co., Inc. (MRK) announced the positive results from the Phase 2b/3 clinical trial (MK-1654-004) evaluating clesrovimab, the company's investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease during their first RSV season.

Results from the Phase 2b/3 pivotal trial, which evaluated 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 (AEs) and serious adverse events were comparable between the clesrovimab and placebo groups, and there were no treatment or RSV-related deaths during the study.

In the Phase 2b/3 trial, clesrovimab reduced RSV-associated hospitalizations (secondary endpoint) and RSV-associated lower respiratory infection hospitalizations (tertiary endpoint) by more than 84% and 90%, respectively, through 5 months.

In addition, Merck announced data from a planned interim analysis of the MK-1654-007 trial, a Phase 3 trial evaluating the safety and efficacy of clesrovimab versus palivizumab in infants and children at increased risk for severe RSV disease. The primary endpoint of the study is the safety and tolerability of clesrovimab in infants entering their first RSV season.

Interim results showed clesrovimab had a comparable safety profile to palivizumab, and no drug-related serious adverse events were reported to date. Incidence rates of RSV-associated MALRI requiring greater than or equal to 1 indicator of lower respiratory infection or severity and RSV-associated hospitalizations (secondary endpoints) were also comparable between clesrovimab (3.6% and 1.3%, respectively) and palivizumab (3.0% and 1.5%, respectively) through Day 150 (5 months).

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