Merck's logo is shown on a screen at the New York Stock Exchange on November 17, 2021.
Andrew Kelly | Reuters
Merck said Thursday that its experimental treatment to protect infants against respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company a step closer to applying 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 in older Americans and hundreds of deaths in infants each year. Complications from the virus are the most common cause of hospitalization in newborns, making Merck's drug a valuable new treatment option if approved.
According to a press release, Merck plans to discuss the study data with regulators worldwide with the goal of making the treatment available to infants as early as the 2025 to 2026 RSV season.
The study examined the safety and effectiveness of a single dose of the treatment, clesrovimab, in healthy premature and full-term infants entering their first RSV season. Merck presented the results at the IDWeek medical conference in Los Angeles.
Merck said the treatment reduced RSV-related hospitalizations by more than 84% and hospitalizations due to lower respiratory tract infections by 90% compared to a placebo in infants as young as five months old. Clesrovimab also reduced lower respiratory tract infections requiring medical attention by more than 60% over five months compared to a placebo.
RSV is a common cause of lower respiratory tract infections such as pneumonia. The results were consistent at both five and six months of the study, Merck said.
The frequency of adverse and serious side effects was similar between patients who received Merck's shot and those who took placebo in the study. The company added that there were no treatment-related or RSV-related deaths in the study.
“These promising results, showing a lower incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in alleviating the ongoing RSV burden for infants and their families,” Dr. Octavio Ramilo, chairman of the Division of Infectious Diseases at St. Jude's Children's Research Hospital, said the Merck press release. Ramilo is also involved in the court proceedings as an investigator.
Merck's clesrovimab could potentially compete with a similar treatment Sanofi And AstraZeneca called Beyfortus, which was in short supply across the country last RSV season due to unprecedented demand. Both are monoclonal antibodies that release antibodies directly into the bloodstream, providing immediate protection.
However, Merck's treatment can be given to infants regardless of their weight, which the company says could provide more convenient dosing. Meanwhile, the recommended dosage of Beyfortus is based on an infant's body weight.
Last year, Pfizer And GSK Introduction of RSV vaccines given to expectant mothers that can pass protection to their fetuses.
Comments are closed.