Stallergenes S.A.: Positive Results From a Phase IIb/III Clinical Trial on the House Dust Mite Desensitization Tablet
announces the release of the first year outcome of its phase IIb/III clinical
trial (VO 57.07) on a sublingual house dust mite desensitization tablet.
“We are very pleased with the outcome of this study, which is the first
large study to ever demonstrate the efficacy of house dust mites allergen in
treating perennial allergic rhinitis. Furthermore, the unexpected quick onset
of action and the good safety profile are addressing the needs of patients
with moderate to severe forms of the disease. This study will be pivotal in
the European registration process of our house dust mites sublingual tablet,
and the basis for further developments in our program” states
Chairman and CEO of Stallergenes. “This study is a genuine landmark which
confirms desensitization as a new therapeutic class in the management of
allergic respiratory disorders. Stallergenes has been consolidating its
leadership in this field through its innovative and development capabilities”.
Stallergenes has been conducting a phase IIb/III clinical trial, with a
sublingual tablet in adults suffering from moderate to severe persistent
allergic rhinitis to house dust mites, including 509 patients, over seven
countries, with a full year of treatment from January to
study compared two treated groups, one with a daily intake of 300 IR
sublingual tablet, the other of 500 IR, with a placebo group. The endpoint
was the adjusted average symptom score on nasal symptoms assessed during the
three last months of the year.
The two treated groups have demonstrated a highly significant statistical
difference on the primary endpoint versus the placebo group (p less than or
equal to 0.0136), with no difference between the two treated groups. In the
different groups, use of rescue medication was allowed throughout the period.
The adjusted average symptom score has been improved by 20% in both treated
groups. In particular, the nasal congestion score has been improved by 40%
(median) and the nasal pruritus by 32% (median). The safety profile has been
For the same level of efficacy, the 300 IR tablet has been selected.
Furthermore, the onset of action was achieved from the 4th month of
treatment, meaning that the difference between the placebo and the treated
groups was statistically significant, the treatment effect being maintained
at the same level up to the end of the study.
The quality of life has been statistically improved and the proportion of
symptom-controlled days increased by 52%.
The study will be pursued over 1 year on an observational basis in
accordance with protocol.
“The conduct of clinical trials in perennial allergic rhinitis is a major
challenge. The outcomes of the VO57.07 are clearly good and consistent,
clinically important and relevant”, said Prof.
international coordinator of the study. “These results are more than
promising for the roll-over of the development of house dust mites sublingual
About House Dust Mites Allergic Rhinitis
caused by house dust mites, making this the leading cause of respiratory
allergy ahead of grass pollens. From early childhood, house dust mites can
trigger allergic rhinitis, worsening over time with a natural progression
towards asthma. The symptoms may be severe, significantly impairing patients’
quality of life.
About the Stalair(R) Development Program
According to World Health Organization (WHO) estimates, 20 to 25% of the
world’s population currently suffers from respiratory allergic symptoms
(rhinoconjunctivitis, rhinitis and/or asthma). By 2020, 50% of the world’s
population may be affected by at least one allergy according to the ISAAC
study. For nearly 15 to 20% of patients currently suffering from severe
allergic rhinitis and rhinoconjunctivitis, their condition is not adequately
controlled and has an adverse effect on their quality of life.
Sublingual desensitization therapy is fully recognized and coded by
international consensus (ARIA), under the aegis of WHO. Supported by a high
level of evidence, this consensus recommends the use of desensitization
therapy when the patient’s allergy is not adequately controlled by
symptomatic treatments, which act on the symptoms of the condition without
addressing its cause.
To date, desensitization therapy is the only treatment option that treats
the immunological causes of allergies and modifies the natural course of the
disease, preventing it from worsening.
Since 2003, Stallergenes has been running the Stalair(R) program, which
aims to address the immunological cause of respiratory allergies with
EBM-documented, registered allergen tablets. This program consists in the
development of tablets for five of the main allergens triggering more than
80% of allergies: grass pollens, house dust mites, birch pollen, ragweed
pollen, Japanese cedar pollen. The entire program is in the clinical
development stage and is proceeding according to schedule.
The first tablet from the program, Oralair(R) (a desensitization tablet
for grass pollens) is available in
tablet is currently being evaluated in other European countries, with a view
to bringing it to market in 2010.
Stallergenes is a European biopharmaceutical company dedicated to
desensitization therapies for the prevention and treatment of allergy-related
respiratory diseases, such as rhinoconjunctivitis, rhinitis and allergic
asthma. A pioneer and leader in sublingual desensitization treatments,
Stallergenes devotes 21% of its turnover, in gross terms, to Research and
Development and is actively involved in the development of a new therapeutic
class: sublingual desensitization tablets.
In 2008, Stallergenes had a turnover of
500,000 patients were treated with Stallergenes desensitization products.
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