Merck Reports Phase 2b/3 Trial Results for RSV Preventative Antibody Clesrovimab in Infants

Merck, known as MSD outside the United States and Canada, has announced promising topline results from its Phase 2b/3 clinical trial (MK-1654-004) which focuses on clesrovimab (MK-1654). This investigational monoclonal antibody aims to protect infants from respiratory syncytial virus (RSV), a virus known to cause serious respiratory infections. The trial demonstrated that clesrovimab met all primary safety and efficacy endpoints, including a significant reduction in RSV-induced medically attended lower respiratory infections (MALRI) up to 150 days post-treatment. Merck plans to present detailed findings at an upcoming scientific conference and will submit the data to global regulatory bodies for review.

Dr. Paula Annunziato, who is the senior vice president of infectious diseases and vaccines at Merck Research Laboratories, emphasized the contagious nature of RSV and its potential to cause severe respiratory issues in infants. She highlighted the global burden of RSV, which is the leading cause of hospitalization among healthy infants worldwide. Dr. Annunziato expressed optimism over the trial's positive outcomes and indicated that Merck is eager to work with regulators to provide a new preventive option for RSV.

The clinical trial, MK-1654-004, was a double-blind, randomized, placebo-controlled study. It assessed both the safety and efficacy of clesrovimab in healthy preterm and full-term infants. Participants were randomly assigned to receive either a single dose of clesrovimab or a placebo. Primary endpoints included the incidence of RSV-associated MALRI from day one through day 150 post-dose, and various safety measures. Safety assessments included the percentage of participants experiencing injection-related adverse events, adverse events of special interest, solicited systemic adverse events, or serious adverse events.

Clesrovimab (MK-1654) is designed as a passive immunization to prevent RSV-related medically attended lower respiratory infections. The monoclonal antibody has an extended half-life, which facilitates durable protection when administered as a single fixed dose, covering infants through their first RSV season.

RSV is a highly contagious virus that leads to seasonal respiratory infections globally, affecting both infants and older adults. Among healthy infants under one year old, RSV is the leading cause of hospitalization worldwide. It can result in severe respiratory conditions such as bronchiolitis and pneumonia, contributing to approximately 101,000 deaths each year among children under the age of five. This underscores the urgent need for effective preventive measures.

Merck, or MSD outside the U.S. and Canada, has been a leader in biopharmaceutical innovation for more than 130 years. The company is committed to utilizing advanced science to improve and save lives worldwide. Known for its development of crucial medicines and vaccines, Merck aims to be a premier research-intensive biopharmaceutical organization. The company is dedicated to fostering a diverse and inclusive global workforce while maintaining responsible and sustainable practices to ensure a healthier future for all communities.

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