Oct 17 (Reuters) -
Merck ( MRK ) 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 ( MRK ) said.
The incidence of treatment-related side effects were
comparable between the clesrovimab and placebo groups, Merck ( MRK )
said, adding that there were no treatment or RSV-related deaths
during the study.
Merck ( MRK ) 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 ( AZN ) 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 ( MRK ) reported on Thursday that clesrovimab had a comparable
safety profile to Synagis, citing interim results from a
separate late-stage study.
Pfizer's ( PFE ) 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.