On November 17, 2021, the Merck logo will appear on the screens of the New York Stock Exchange.
Andrew Kelly Reuter
Merck it said on thursday experimental treatment A vaccine designed to protect infants from respiratory syncytial virus 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. thousands of Each year, the number of deaths among older Americans and infants is in the hundreds. Viral complications are a leading cause of hospitalization in newborns, and Merck’s drug, if approved, would represent a valuable new treatment option.
According to the release, Merck will discuss the study data with regulatory authorities around the world with the goal of making the treatment available to infants as early as the 2025-2026 RSV season.
This study investigated the safety and efficacy of a single dose of the drug clethrovimab 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 lower respiratory tract infection hospitalizations by 90% compared with placebo in infants up to 5 months of age. Creslovimab also reduced lower respiratory tract infections requiring medical care by more than 60% over a five-month period compared to 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 points of the trial.
In this study, the incidence of adverse or serious side effects was similar between patients who received Merck’s injection and those who took a placebo. There were no treatment- or RSV-related deaths in this study, the company added.
“These encouraging results showing reduced rates of RSV illness, including hospitalization, highlight the potential for cleslovimab to play an important role in reducing the continuing burden of RSV on infants and their families. ” said Dr. Octavio Ramiro of the ministry. Infections at St. Jude Children’s Research Hospital, Merck & Co. said in a release. Ramiro is also an investigator working on clinical trials.
Merck’s clethrovimab may compete with similar treatments in the United States. sanofi and AstraZeneca It’s called bay fortus, and last year’s RSV season saw a national shortage due to unprecedented demand. Both are monoclonal antibodies, which deliver antibodies directly into the bloodstream to provide immediate protection.
However, Merck’s therapy can be given to infants regardless of their weight, which could offer convenience in terms of administration, the company said. On the other hand, the recommended dose of Beyfortas is based on the infant’s weight.
last year, pfizer and GSK We have rolled out an RSV vaccine that can be given to pregnant women and pass protection on to their fetuses.