The trial showed that clesrovimab reduced RSV-related respiratory infections in infants through day 150.
RT’s Three Key Takeaways:
- Trial Results: Merck’s phase 2b/3 clinical trial for clesrovimab (MK-1654) met its primary safety and efficacy endpoints, demonstrating a reduction in RSV-related respiratory infections in infants.
- Vaccination Impact: Clesrovimab, an investigational monoclonal antibody, is designed to provide rapid and durable protection against RSV in preterm and full-term infants, potentially safeguarding them through their first RSV season with a single dose.
- Regulatory Path Forward: Merck plans to present detailed findings at an upcoming scientific congress and will submit the data to global regulatory authorities.
Merck announced positive topline results from its phase 2b/3 clinical trial evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.
In the trial, clesrovimab met its primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections caused by RSV through day 150. Findings of the study will be presented at an upcoming scientific congress, and Merck plans to file these data with global regulatory authorities, according to a release from the company.
“RSV is highly contagious and can cause inflammation in the airways of infants leading to difficulty breathing. As a widespread illness globally, RSV is the leading cause of hospitalization for healthy infants,” says Paula Annunziato, MD, senior vice president of infectious diseases and vaccines, Global Clinical Development, Merck Research Laboratories, in a release. “We are encouraged by these findings and look forward to working with regulators to provide a new option to help address the impact of RSV on infants and their families.”
Study Design and Outcomes of the Clesrovimab Trial
The phase 2b/3 double-blind, randomized, placebo-controlled study is designed to evaluate the safety and efficacy of clesrovimab in healthy preterm and full-term infants. Participants were randomized to receive either a single dose of clesrovimab, via intramuscular injection, or placebo.
The primary endpoints include the incidence of participants with RSV-associated medically attended lower respiratory infection from day 1 (post-dose) to day 150 as compared to placebo and safety. Safety measures assessed included the percentage of participants with any injection-related adverse events (AEs), AEs of special interest, solicited systemic AEs, or serious adverse events.
Monoclonal Antibody
Clesrovimab is an investigational extended half-life monoclonal antibody developed as a passive immunization for the prevention of RSV-associated medically attended lower respiratory infection. Clesrovimab is being studied in infants (pre-term and full-term) to provide rapid, durable protection through their first RSV season with a single, fixed-dose administration.
Respiratory syncytial virus is the leading cause of hospitalization for healthy infants under a year old globally. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 101,000 deaths a year worldwide in children under 5.
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