Merck's antibody-based drug MK-1654 met the primary endpoint in a phase II/III trial for the prevention of respiratory syncytial virus in infants, the company announced.
The injected treatment significantly reduced the incidence of lower respiratory tract infections in infants compared to placebo and met the study's safety objectives.
Merck plans to submit the trial data to global regulatory authorities and will present detailed findings at an upcoming scientific congress.
RSV is a seasonal respiratory virus that typically causes mild, cold-like symptoms. However, infants and older adults are at a higher risk of developing severe respiratory syncytial virus (RSV)-related illness, which is a leading cause of pneumonia in these populations. RSV results in approximately 177,000 hospitalizations and 14,000 deaths annually in the U.S.
The FDA has approved Nirsevimab, a long-acting antibody therapy for the prevention of RSV in children up to 24 months of age.
Additionally, Pfizer's maternal RSV vaccine is available to protect young infants. It is recommended for administration to women 32 to 36 weeks into pregnancy to prevent lower respiratory tract infections and severe disease in infants up to six months old.