Merck on Thursday said its experimental treatment designed to protect infants from respiratory syncytial virus showed positive results in a mid- to late-stage trial, bringing the company one step closer to filing for approval of the shot.
The trial examined the safety and efficacy of a single dose of the treatment, clesrovimab, in healthy preterm and full-term infants entering their first RSV season.
Results were consistent through both the five-month and six-month time points in the trial, Merck said.
Merck’s clesrovimab could potentially compete against a similar treatment from Sanofi and AstraZeneca called Beyfortus, which was in short supply nationwide last RSV season due to unprecedented demand.
But Merck’s treatment can be administered to infants regardless of their weight, which the company said may offer convenience in terms of dosing.
Merck announced Thursday that a mid- to late-stage trial of its experimental treatment for respiratory syncytial virus protection in infants had shown promising results, moving the company closer to submitting an application for approval of the vaccine.
With RSV causing hundreds of infant deaths and thousands of older American deaths annually, the pharmaceutical behemoth may become a new rival in the market for treatments. The most common reason for hospitalization among newborns is virus-related complications, so if approved, Merck’s medication would be a useful new treatment option.
Merck said in a release that it intends to share the study data with regulators around the world in order to make the treatment available for infants as early as the 2025–2026 RSV season.
In healthy preterm and full-term infants starting their first RSV season, the trial investigated the safety and effectiveness of a single dose of the medication, clesrovimab. The findings were presented by Merck at the Los Angeles medical conference IDWeek.
In comparison to a placebo, the treatment decreased hospitalizations for lower respiratory infections by 90% and hospitalizations related to RSV by over 84% among infants aged 0–5 months, according to Merck. Over the course of five months, clerovimab also decreased lower respiratory infections that needed medical intervention by over 60% when compared to a placebo.
Pneumonia and other lower respiratory tract infections are frequently caused by RSV. According to Merck, the trial’s outcomes remained consistent at the five- and six-month time points.
The trial found that patients who received Merck’s shot and those who received placebos experienced similar rates of serious and adverse side effects. The company added that the study did not include any treatment-related or RSV-related deaths.
Clesrovimab may be able to help lessen the ongoing burden of RSV on infants and their families, according to these encouraging findings showing a lower incidence of RSV disease, including hospitalizations, said Dr. Octavio Ramilo, chair of the Department of Infectious Diseases at St. In a press release from Merck, Jude’s Children’s Research Hospital stated. Ramilo is an investigator involved in the trials as well.
A comparable medication from Sanofi and AstraZeneca called Beyfortus, which was in short supply nationwide during the previous RSV season due to extraordinary demand, may face competition from Merck’s clesrovimab. Both of them are monoclonal antibodies, which offer instant protection by delivering antibodies straight into the circulation.
However, Merck’s medication can be given to babies of any weight, which could make dosing easier, according to the company. Beyfortus dosage recommendations, meanwhile, are determined by the weight of the baby.
