Mark says experimental RSV treatments protect children in trials, paving the way for potential approval

Mark The experimental treatment designed to protect children from respiratory syncytial virus has shown positive results in mid- to late-stage trials, the company said Thursday, bringing the company one step closer to filing for approval of the shot.

The pharmaceutical giant could emerge as a new competitor in the market for treatments against RSV, which causes thousands of deaths among older Americans and hundreds of deaths in children each year. Viral complications are the leading cause of hospital admissions in newborns, making the Merck drug a valuable new treatment option if approved.

According to a release, Merck plans to discuss the study data with global regulators with the goal of making the treatment available to children as early as the 2025 to 2026 RSV season.

The trial tested the safety and efficacy of a single dose of treatment, claserovimab, in healthy preterm and full-term infants entering their first RSV season. Mark presented the results at the IDWK Medical Conference in Los Angeles.

According to Mark, the treatment reduced RSV-related hospitalizations by more than 84% and hospitalizations due to lower respiratory tract infections by 90%, compared with placebo in children over five months. Clerovimab also reduced lower respiratory tract infections requiring treatment by more than 60% compared with placebo over five months.

RSV is a common cause of lower respiratory tract infections such as pneumonia. Results were consistent through both the five-month and six-month time points in the trial, Mark said.

The rates of adverse and serious side effects were comparable between patients receiving Merck's shot and those receiving placebos in the trial. There were no treatment- or RSV-related deaths in the study, the agency added.

“These promising results demonstrate a reduction in the incidence of RSV disease, including hospitalizations, highlighting the potential for claserovimab to play an important role in helping to reduce the continuing burden of RSV on children and their families,” said Dr. Octavio Ramillo, Division Chair at St. Jude's Children's Research Hospital. Infectious diseases, Dr. Mark's release. Ramillo is also an investigator working on the trial.

Merck's claserovimab could potentially compete against a similar treatment Sanofi And AstraZeneca called Beyfortus, which was in short supply nationwide last RSV season due to unprecedented demand. Both are monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection.

But Merck's treatment can be administered to children regardless of their weight, which the company says could offer advantages in dosing. Meanwhile, the recommended dose of Beyfortus is based on a child's body weight.

last year, Pfizer And GSK RSV vaccines have been introduced that are given to expectant mothers to protect their fetuses.