The Merck logo is displayed on a screen at the New York Stock Exchange on November 17, 2021.
Andrew Kelly | Reuters
Merck The US drugmaker said on Thursday that its experimental treatment designed to protect infants from respiratory syncytial virus showed positive results in a mid- to late-stage trial, moving the company one step closer to submitting an application for approval of the vaccine.
The pharmaceutical giant could emerge as a new competitor in the market for treatments against the RSV virus, 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 season, according to a statement.
The trial tested the safety and effectiveness of a single dose of the treatment, clesrovimab, in healthy preterm infants and full-term infants entering their first RSV season. Merck presented the findings at the IDWeek medical conference in Los Angeles.
The treatment reduced RSV-related hospitalizations by more than 84% and hospitalizations for lower respiratory tract infections by 90% compared to placebo among infants at five months, according to Merck. Clesrovimab also reduced the incidence of lower respiratory tract infections requiring medical attention by more than 60% compared to placebo over five months.
Respiratory syncytial virus (RSV) is a common cause of lower respiratory tract infections such as pneumonia. Merck said results were consistent across the five-month and six-month time periods in the trial.
Rates of adverse and serious side effects were comparable between patients who received Merck's shot and those who took a placebo in the trial. The company added that there were no cures or deaths associated with respiratory syncytial virus in the study.
“These promising results demonstrating a lower incidence of RSV disease, including hospitalization, highlight the potential for clesrovimab to play an important role in helping to alleviate the ongoing burden of RSV on infants and their families,” said Dr. Octavio Ramillo, Head of the Department of Infectious Diseases at RSV Hospital. St. Jude Children's Research, Merck said in a statement. Ramilo is also an investigator who works on experiments.
Merck's clesrovimab will likely compete with a similar treatment from Merck Sanofi and AstraZeneca It's called Beyfortus, which was in short supply nationwide this past 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 infants regardless of their weight, which the company said may provide relief in terms of dosing. Meanwhile, the recommended dose of Beyfortus depends on the infant's body weight.
last year, Pfizer and GlaxoSmithKline Introducing RSV vaccines that are given to pregnant mothers that can transfer protection to their fetuses.
