(Reuters) – Merck said on Thursday its experimental antibody therapy, clesrovimab, demonstrated a 60.4% effectiveness in reducing respiratory syncytial virus (RSV) infections in infants.
The seasonal shot met its primary goal in the mid-to-late stage trial, reducing the incidence of lower respiratory tract infections in healthy infants up to one year of age entering their first RSV season.
The drug also helped reduce RSV-associated hospitalizations by 84.2% compared to placebo, Merck said.
The incidence of treatment-related side effects were comparable between the clesrovimab and placebo groups, Merck said, adding that there were no treatment or RSV-related deaths during the study.
Merck had said in July that the shot met the main goal in the study, but did not give details.
If approved, clesrovimab will compete in the U.S. market with Sanofi and AstraZeneca’s antibody therapy Beyfortus.
The FDA approved Beyfortus last year to prevent RSV infection in infants and toddlers, also administered once per season.
In a separate late-stage study, Beyfortus showed a 74.5% reduction in the incidence of lower respiratory tract infections requiring medical care in infants.
Swedish Orphan Biovitrum’s preventive RSV therapy Synagis is also available as a monthly injection.
Merck reported on Thursday that clesrovimab had a comparable safety profile to Synagis, citing interim results from a separate late-stage study.
Pfizer’s RSV vaccine, Abrysvo, is approved for use in pregnant women to prevent RSV infections in babies during the first six months after birth.
RSV, which typically causes cold-like symptoms, is a leading cause of pneumonia and death in babies and older adults. The virus leads to 177,000 hospitalizations and 14,000 deaths annually in the United States.
(Reporting by Mariam Sunny in Bengaluru; Editing by Tasim Zahid)
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