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FRANKFURT, Oct 21 (Reuters) - GlaxoSmithKline said
it would move its experimental vaccine against the respiratory
syncytial virus (RSV), a cause of pneumonia in toddlers and the
elderly, into the final stage of testing, encouraged by
mid-stage trial results.
RSV vaccine development has been fraught with setbacks for
decades but the pharma industry is gearing up to bring a first
inoculation to market over the next few years.
The area is a key growth opportunity for GSK, as it seeks to
offset declining sales of its blockbuster lung drug Advair due
to generic competition.
GSK said a Phase I/II trial with about 1,000 healthy adults
aged 60-80 showed that the vaccine prompted a "robust" increase
in antibodies and immune cells one month after injection,
indicating a stimulated immune system.
A separate product, designed to give pregnant women the
ability to confer immunity to their unborn children, led to high
levels of protective neutralising antibodies in non-pregnant
healthy woman taking part in a Phase I/II trial.
GSK said Phase III studies, with the potential to produce
data for regulatory approval, would likely start over the coming
months.
The vaccines were well-tolerated with side effects including
injection-site pain and headache, GSK added.
Companies including Johnson &, Sanofi and
Moderna are competing to get a vaccine approved against
RSV, which globally leads to about 3 million hospital stays for
children under five per year.
Swedish Orphan Biovitrum's Synagis, a monthly
shot, is currently the only preventive treatment against RSV in
high-risk infants. Sanofi and partner AstraZeneca
are working on longer-acting nirsevimab, which could be
given once per cold season to that group, if approved.
GSK is also conducting early-stage studies of an RSV vaccine
for children and plans to publish results some time between Oct.
26-29 for a subgroup of children which already had some exposure
to the virus.
(Reporting by Ludwig Burger. Editing by Jane Merriman)
