The Merck logo is displayed on a screen at the New York Stock Exchange on November 17, 2021.
Andrew Kelly | Reuters
merck It said Thursday that its experimental treatment designed to protect babies from respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company closer to seeking approval of the shot.
The pharmaceutical giant could emerge as a new competitor in the market for RSV treatments, which causes thousands of deaths among older Americans and hundreds of deaths among infants each year. Complications from the virus are the leading cause of hospitalization among newborns, making Merck's drug a valuable new treatment option if approved.
Merck plans to discuss the study 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 statement.
The trial 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.
According to Merck, the treatment reduced RSV-related hospitalizations by more than 84% and decreased hospitalizations for lower respiratory tract infections by 90% compared to a placebo among infants up to five months old. Clesrovimab also reduced lower respiratory tract infections requiring medical attention by more than 60% compared to a placebo over five months.
RSV is a common cause of lower respiratory tract infections, such as pneumonia. The results were consistent throughout the five and six months of the trial, Merck said.
Rates of adverse and serious side effects were comparable between patients who received the Merck injection and those who took placebos in the trial. There were no treatment or deaths related to RSV 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 to alleviate the ongoing burden of RSV on infants and their families,” he said. Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude Children's Research Hospital, said in the Merck statement. Ramilo is also a researcher working on the trials.
Merck's clesrovimab could potentially compete with a similar treatment for sanafi 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 given to babies regardless of their weight, which the company says may offer convenience in terms of dosing. Meanwhile, the recommended dosage of Beyfortus is based on the baby's body weight.
Last year, Pfizer and GSK launched RSV vaccines that are administered to pregnant women that can transmit protection to their fetuses.
