Merck's logo will be displayed on a screen at the New York Stock Exchange on November 17, 2021.
Andrew Kelly | Reuters
Merck said Thursday that the experimental treatment designed to protect babies against respiratory syncytial virus produced positive results in a mid- to late-stage trial, moving the company a 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 among infants every year. Complications from the virus are the leading cause of hospitalizations among newborns, making Merck's drug, if approved, could be a valuable new treatment option.
Merck plans to discuss the trial data with regulators around the world, with the goal of making the treatment available to infants as early as the 2025 to 2026 RSV season, according to a news release.
The study examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season. Merck presented the results at the IDWeek medical conference in Los Angeles.
According to Merck, the treatment reduced RSV-related hospital admissions by more than 84% and hospital admissions due to lower respiratory tract infections by 90% compared to a placebo in infants over five months. Clesrovimab also reduced lower respiratory infections requiring medical attention by more than 60% compared to a placebo over five months.
RSV is a common cause of lower respiratory infections, such as pneumonia. The results were consistent over both the five- and six-month periods of the trial, Merck said.
Rates of adverse and serious side effects were similar between patients who received Merck's shot and those who took placebos in the study. There were no treatment- or RSV-related deaths in the study, the company added.
“These promising results demonstrating reduced incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play an important role in helping alleviate the ongoing burden of RSV for infants and their families,” Dr. Octavio Ramilo, chairman of the Division of Infectious Diseases at St. Jude's Children's Research Hospital, said in Merck's press release. Ramilo is also a researcher working on the processes.
Merck's Clesrovimab could potentially compete with 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 release antibodies directly into the bloodstream to provide immediate protection.
But Merck's treatment can be administered to babies regardless of their weight, which the company says can provide convenience in terms of dosing. Meanwhile, the recommended dosage of Beyfortus is based on a baby's body weight.
Last year, Pfizer And GSK Rolling out RSV vaccines administered to expectant mothers who can pass the protection on to their fetuses.