HQ Team
July 24, 2024: The US-based Merck and Co.’s investigational medicine to protect infants from respiratory syncytial virus (RSV) disease has resulted in lowering infections, according to the company.
The mid-and end-stage trials of clesrovimab or MK-1654-004 antibody-based injection “met its primary safety and efficacy endpoints,” according to a statement from the New Jersey-based pharmaceutical company.
Merck will file the data for regulatory approvals after it presents the findings of the study at an upcoming scientific congress.
“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, of 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.”
Pre-term, full-term
The safety and efficacy of clesrovimab in healthy preterm and full-term infants were tested during the trials.
Participants were randomized to receive either a single dose of clesrovimab or a placebo. The primary endpoints included 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.
Clesrovimab was studied in infants (pre-term and full-term) to provide rapid, durable protection through their first RSV season with a single, fixed-dose administration, according to the statement.
RSV is a contagious virus that causes widespread seasonal infection with a worldwide burden in infants and older adults. There is a high unmet need for preventative options in both healthy and high-risk infants.
Globally, it is the leading cause of hospitalization for healthy infants under a year old. RSV can lead to serious respiratory conditions like bronchiolitis and pneumonia, causing an estimated 101,000 deaths a year worldwide in children under five.
Wheezing cough
People who become infected with RSV show symptoms within four to six days after the virus enters the body, according to the American Lung Association.
Initial signs of RSV are similar to mild cold symptoms, including sneezing, runny nose, fever, cough and decrease in appetite. Very young infants may be irritable, fatigued and have breathing difficulties.
These symptoms do not usually all show up at the same time, instead, they come in stages. Normally these symptoms will clear up on their own in a few days.
A barking or wheezing cough can be one of the first signs of a more serious illness. In these instances, the virus has spread to the lower respiratory tract, causing inflammation of the small airways entering the lungs. This can lead to pneumonia or bronchiolitis.
