Merck says experimental RSV treatment protected babies in trial | Wilnesh News

Merck said on thursday experimental treatment A vaccine designed to protect infants against respiratory syncytial virus infection has shown positive results in mid-to-late-stage trials, bringing the company one step closer to applying for approval of the vaccine.

The pharmaceutical giant could emerge as a new competitor in the RSV treatment market, leading to Thousands Hundreds of older Americans die each year and hundreds of infants die. Complications caused by the virus are a leading cause of hospitalization for newborns, and if approved, Merck’s drug would become a valuable new treatment option.

Merck plans to discuss study data with regulatory agencies around the world, with the goal of making the treatment available to infants as early as the 2025-2026 RSV season, according to a press release.

The trial examined the safety and efficacy of a single dose of clesrovimab treatment in healthy preterm and term infants entering their first RSV season. Merck announced the results at the IDWeek medical conference in Los Angeles.

According to Merck, the treatment reduced RSV-related hospitalizations by more than 84% and hospitalizations due to lower respiratory tract infections by 90% in infants under 5 months of age compared with placebo. Clesrovimab also reduced lower respiratory tract infections requiring medical attention by more than 60% over five months compared with placebo.

RSV is a common cause of lower respiratory tract infection Such as pneumonia. Merck said the results were consistent at both the five- and six-month time points of the trial.

In the trial, patients who received Merck’s injection had similar rates of adverse reactions and serious side effects as those who took a placebo. There were no treatment or RSV-related deaths in the study, the company added.

“These encouraging results show a decrease in the incidence of RSV illness, including hospitalization, and highlight the potential of clesrovimab to play an important role in helping reduce the ongoing burden of RSV on infants and their families,” said Octavio Ramilo, Ph.D., chief of the division. explain. Ramiro is also an investigator involved in the trial.

Merck’s clesrovimab may compete with similar treatments from the U.S. Sanofi and AstraZeneca The product, called Beyfortus, was in short supply nationwide last RSV season due to unprecedented demand. Both are monoclonal antibodies that deliver antibodies directly into the bloodstream to provide immediate protection.

But Merck’s treatment can be administered to infants regardless of their weight, which the company said may offer convenience in dosing. Also, the recommended dose of Beyfortus is based on the baby’s weight.

last year, Pfizer and GSK RSV vaccines were introduced to give pregnant women the RSV vaccine, which can pass protection to the fetus.