HØRSHOLM, Denmark, June 13, 2016 /PRNewswire/ --
- Treatment benefit increased over time. In the
two years after treatment completion, the
estimated risk of experiencing asthma symptoms
nearly halved
- Significant improvement in allergic rhinoconjunctivitis
symptoms, with benefit sustained two years after end of
treatment
- Patients showed modified immunological responses to grass
pollen, indicating inhibition of disease
progression
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today presented new
data from the GRAZAX® Asthma
Prevention (GAP) trial with GRAZAX®, ALK's allergy
immunotherapy tablet against grass pollen allergy.
The data, presented at the 2016 Annual Congress of the European
Academy of Allergy and Clinical Immunology (EAACI) in Vienna, confirm that GRAZAX® can
prevent asthma symptoms, as well as offering sustained relief from
grass allergy symptoms. Moreover, immunological findings were
highly supportive of the disease-modifying nature of the
treatment.
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The GAP trial is the largest allergy immunotherapy trial ever
conducted in children and investigated the effect of
GRAZAX® versus placebo on the risk of developing asthma.
It involved a three-year treatment phase and a two-year follow-up
phase and included 812 children aged 5-12 years at the start of
treatment.
New data confirms prevention of asthma symptoms
The detailed analysis of the GAP trial results confirmed that
treatment with GRAZAX® prevented asthma symptoms in
children:
- GRAZAX® treatment reduced the proportion of patients
with asthma symptoms[1]or use of asthma
medication[2] Asthma medication included
short-acting beta-2-agonist (SABA), systemic corticosteroid,
inhaled corticosteroid (ICS), leukotriene receptor antagonist
(LTRA), long-acting beta-2-agonist (LABA), systemic corticosteroid,
inhaled corticosteroid (ICS), sustained-release theophylline, or
cromolyn sodium. when evaluated at end of trial, i.e., two years
post treatment (Odds Ratio: 0.66, p<0.05)
- GRAZAX® treatment also reduced the proportion of
patients experiencing asthma symptoms during the entire five year
trial period (Odds Ratio: 0.71, p<0.05) with the effect most
pronounced during the two year post-treatment period (Odds Ratio:
0.55, p<0.05)
In addition, the treatment effect increased with time and was
apparent both during the grass pollen season and during winter.
Moreover, the GAP trial demonstrated the efficacy of
GRAZAX® on grass allergic rhinoconjunctivitis in
children, with benefits persisting for two years after
treatment.
Inhibition of disease progression
The trial also yielded new data, with the detailed analysis of
patients' immunological response supportive of early intervention
with GRAZAX®.
Two years after treatment, GRAZAX®-treated children
were less IgE sensitised to grass pollen and had lower total IgE,
both indicating a reduced allergic response. GRAZAX®
patients also had higher grass pollen-specific IgG4 levels,
indicating raised immunological tolerance. Meanwhile, the wheal
size from the skin prick test using grass allergen - an indicator
of the extent of an allergic reaction - was significantly smaller
for the GRAZAX® group than for the placebo group.
The continued analysis of data from the GAP landmark trial
follows the initial release of top-line data in January 2016. This showed that GRAZAX® treatment
significantly reduced the proportion of children experiencing
asthma symptoms or using asthma medication, however there was no
detectable effect in terms of time to the first diagnosis of
reversible impairment of lung function and the primary endpoint of
the trial was therefore not met. The safety and tolerability of
GRAZAX® were both favourable and in line with previous
studies, with no new or unexpected findings.
Erkka Valovirta, paediatric allergist, Adjunct Professor at the
University of Turku, Finland, and
principal investigator for the GAP trial, said: "These
results further enhance our understanding of allergic
disease and the benefit of GRAZAX®
treatment for children whose grass allergy is not
well controlled by conventional therapies. For the first
time, we also see that, by treating paediatric
patients early enough, we can change the trajectory of
their immune system development."
He added: "The GAP trial provides further evidence that it is
possible to reprogramme the allergic immune response.
It also suggests there may be benefit in offering early treatment
to children in order to minimise the risk of a lifetime of
respiratory disease."
Henrik Jacobi, ALK's Executive
Vice President of Research and Development, said: "We are
particularly excited about these new results. They confirm
the benefit of GRAZAX® in
offering sustained relief from childhood allergic rhinitis both
during and after treatment. They also provide the
strongest evidence yet for the early use of
GRAZAX® in children with
moderate-to-severe allergies and who are at risk of developing
asthma."
He continued: "These insights also reaffirm ALK's position as
the leading innovator in allergy treatment and further advance our
understanding of the way the human immune system responds to
specific allergens."
About the GAP trial
The GRAZAX® Asthma Prevention (GAP) trial
was initiated by ALK in 2009 to evaluate the efficacy and safety of
the grass allergy immunotherapy tablet
(GRAZAX®) in children with allergic
rhinoconjunctivitis. The trial was a randomised, parallel-group,
double-blind, placebo-controlled, multi-national trial
investigating the effect of GRAZAX®
compared to placebo on the risk of developing asthma.
812 children (5-12 years of age) from 101 sites in 11
European countries (Austria,
Denmark, Finland, France, Germany, Great Britain, Norway, Poland, Spain, Sweden and Switzerland) were included in the trial. The
primary criteria for inclusion in the trial were a clinical
relevant history of grass pollen allergic rhinoconjunctivitis
having received symptomatic treatment during the two grass pollen
seasons prior to treatment start and no medical history or signs of
asthma.
The trial consisted of a screening phase, a three-year
treatment phase with daily treatment, and a two-year follow-up
phase. To rule out asthma before randomisation, two screening
visits took place. The purpose of the first screening visit was to
investigate the subject eligibility in terms of all inclusion and
exclusion criteria. At the second screening visit (placed in the
grass pollen season), all subjects were examined according to the
pre-specified asthma diagnosis. Subjects with a suspicion of asthma
or diagnosed with asthma were per definition screening
failures.
After the end of the grass pollen season 2010, eligible
subjects were randomised to GRAZAX®
(N=398) or placebo (N=414) for three consecutive years. The
trial continued with double-blinded follow-up for additional two
years. Independently of whether asthma was diagnosed or not during
the trial, all randomised subjects were to continue in the trial
for five years. Subjects experiencing asthma symptoms during the
trial were instructed to call the investigator for an unscheduled
visit.
The asthma evaluation included four components: asthma
physical examination, asthma medical history, asthma medication
history, and lung-function tests.
About the European Academy of Allergy and Clinical
Immunology (EAACI) Congress
The EAACI Annual Congress is the foremost event of its kind,
drawing allergy experts, policy makers and science media from all
over the world. Its scientific programme and industry-sponsored
sessions provide an important update on the latest research, trends
and product launches in allergy treatment. Find more information
at http://www.eaaci2016.com
About ALK
ALK is a research-driven global pharmaceutical company
focusing on allergy prevention, diagnosis and treatment. ALK is
a world leader in allergy immunotherapy - a treatment of
the underlying cause of allergy. The company has approximately
1,900 employees with subsidiaries, production facilities and
distributors worldwide. ALK has entered into partnership agreements
with MSD (known as Merck (NYSE: MRK) in the
USA and Canada), Torii, Abbott and Seqirus
(previously bioCSL) to commercialise sublingual allergy
immunotherapy tablets in North
America, Japan,
Russia, Australia and New
Zealand, respectively. The company is headquartered
in Hørsholm, Denmark, and listed
on NASDAQ Copenhagen. Find more information at
http://www.alk.net.
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1. Asthma symptoms included wheezing, chest tightness, shortness
of breath or cough for more than 10 days.
2. Asthma medication included short-acting beta-2-agonist
(SABA), systemic corticosteroid, inhaled corticosteroid (ICS),
leukotriene receptor antagonist (LTRA), long-acting beta-2-agonist
(LABA), systemic corticosteroid, inhaled corticosteroid (ICS),
sustained-release theophylline, or cromolyn sodium.
SOURCE ALK