US pharma giant Merck & Co (NYSE: MRK) has released positive top-line results from its Phase IIb/III clinical trial (MK-1654-004) evaluating clesrovimab (MK-1654), the company’s investigational prophylactic monoclonal antibody designed to protect infants from respiratory syncytial virus (RSV) disease.
Merck noted that clesrovimab met its primary safety and efficacy endpoints, including reducing medically attended lower respiratory infections (MALRI) caused by RSV through Day 150. Detailed findings of the study will be presented at an upcoming scientific congress and Merck plans to file these data with global regulatory authorities.
“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,” said Dr Paula Annunziato, senior vice president, infectious diseases and vaccines, global clinical development, Merck Research Laboratories. “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," she added.
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