Merck says experimental RSV treatment protected infants in trial

Merck on Thursday said its experimental treatment designed to guard infants from respiratory syncytial virus showed positive ends in a mid- to late-stage trial, bringing the corporate one step closer to filing for approval of the shot. 

The pharmaceutical giant could emerge as a recent competitor available in the market for treatments against RSV, which causes hundreds of deaths amongst older Americans and tons of of deaths amongst infants annually. Complications from the virus are the leading reason for hospitalization amongst newborns, making Merck’s drug a invaluable recent treatment option if approved.

Merck plans to debate the study data with regulators worldwide, with a goal of constructing the treatment available for infants as early because the 2025 to 2026 RSV season, in response to a release. 

The trial examined the protection 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 outcomes on the medical conference IDWeek in Los Angeles.

The treatment reduced RSV-related hospitalizations by greater than 84% and decreased hospitalizations resulting from lower respiratory infections by 90% compared with a placebo amongst infants through five months, in response to Merck. Clesrovimab also reduced lower respiratory infections that required medical attention by greater than 60% compared with a placebo through five months.

RSV is a typical reason for lower respiratory tract infections comparable to pneumonia. Results were consistent through each the five-month and six-month time points within the trial, Merck said.

The rates of adversarial and serious uncomfortable side effects were comparable between patients who received Merck’s shot and those that took placebos within the trial. There have been no treatment or RSV-related deaths within the study, the corporate added. 

“These promising results demonstrating decreased incidence of RSV disease, including hospitalizations, highlight the potential for clesrovimab to play a very important role in helping to alleviate the continued burden of RSV on infants and their families,” Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. Jude’s Kid’s Research Hospital, said in Merck’s release. Ramilo can be an investigator working on the trials. 

Merck’s clesrovimab could potentially compete against the same treatment from Sanofi and AstraZeneca called Beyfortus, which was in brief supply nationwide last RSV season resulting from unprecedented demand. Each are monoclonal antibodies, which deliver antibodies directly into the bloodstream to supply immediate protection. 

But Merck’s treatment could be administered to infants no matter their weight, which the corporate said may offer convenience when it comes to dosing. Meanwhile, the really useful dosage of Beyfortus is predicated on an infant’s body weight. 

Last yr, Pfizer and GSK rolled out RSV vaccines which are administered to expectant moms who can pass on protection to their fetuses.