HØRSHOLM, Denmark, April 27, 2016 /PRNewswire/ --
ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) today announced that
The Journal of the American Medical Association (JAMA) has
published results from a Phase III clinical trial evaluating the
treatment of house dust mite (HDM) allergic asthma with the
company's HDM sublingual allergy immunotherapy tablet (SLIT-tablet)
ACARIZAX®. The results appear in the latest edition of
JAMA.
(Logo:
http://photos.prnewswire.com/prnh/20160420/357628LOGO )
Professor J. Christian Virchow, University of Rostock, lead
author of the publication said: "JAMA is one of the
world's most prestigious and influential medical
journals and its decision to publish these key results from the
ACARIZAX® clinical development
programme illustrates the ground-breaking nature of this new
treatment."
Henrik Jacobi, ALK's Executive
Vice President of Research and Development, said: "With
its approval in Europe last year,
ACARIZAX® became the first and only HDM
SLIT-tablet to be indicated for both allergic rhinitis and allergic
asthma, and can even be used in patients with not well
controlled house dust mite allergic asthma.
ACARIZAX® works by addressing the cause of
house dust mite respiratory allergic disease and provides an
underlying protection and disease control. The
published results strengthen the case for using
ACARIZAX® to treat house dust mite
allergic asthma".
Trial design
The randomised, double-blind, placebo-controlled trial took
place between August 2011 and
April 2013 and involved 834 adult
patients with HDM allergic asthma and HDM allergic rhinitis, which
were not well-controlled by inhaled corticosteroids (ICS). The
trial was conducted at 109 sites in 13 European countries and forms
part of ALK's ongoing clinical development programme for
ACARIZAX®, which has recently been approved in 11
European countries and where it is currently being launched.
Patients were treated daily with either a 12 SQ-HDM or a 6
SQ-HDM dose, or with placebo in addition to ICS and short-acting
beta-agonists (SABA). After a period of treatment varying between 7
and 12 months, daily ICS use was reduced by half for 3 months and
subsequently withdrawn completely for another 3 months for patients
who did not experience an asthma exacerbation.
The primary endpoint of the trial was reduction in the risk of
moderate to severe asthma exacerbations during steroid reduction as
measured by the time to the first exacerbation
Secondary analysis looked at patients' daytime symptoms,
nocturnal awakenings, their use of SABA - typically used as asthma
'rescue' medication - and the time to their first severe asthma
exacerbation both prior to and during ICS reduction.
Primary endpoint met
The trial showed that 12 SQ-HDM (the dose approved in the EU)
significantly reduced the risk of a moderate or severe asthma
exacerbation relative to placebo with a hazard ratio (HR) of 0.66,
corresponding to a 34% risk reduction. This included:
- A 36% reduction in risk of nocturnal awakening or increase in
daily symptoms (HR: 0.64)
- A 48% reduction in the risk of increased use of SABA treatments
(HR: 0.52)
- A 42% reduction in the deterioration of lung function (HR:
0.58)
ACARIZAX® is also being developed for a number of
other markets around the world in collaboration with ALK's partners
- by MSD (known as Merck in the USA and Canada) for North
America, Abbott for Russia
and South-East Asia, Seqirus for
Australia and New Zealand, and Torii for Japan. Together, these development activities
have involved more than 6,000 patients worldwide and make
ACARIZAX® the best documented product in the history of
HDM allergy immunotherapy. The HDM SLIT-tablet has already been
launched by Torii in Japan under
the brand name MITICURE[TM].
ALK-Abelló A/S
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 to commercialise sublingual allergy immunotherapy tablets
in North America, Japan, Russia and South-East Asia, and 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.
About house dust mite allergy and
ACARIZAX®
House dust mites (HDM) are the most common cause of allergy
in the world. HDM allergy is estimated to affect around 90 million
people in Europe, North America and Japan, and more than 100 million in
China. It is estimated that
one in 10 adults with allergic rhinitis are
poorly controlled with current standard therapies. The condition
appears early in life, is present all year round and patients face
an elevated risk of developing asthma and other allergies.
For some of these patients, the HDM SLIT-tablet is a relevant
treatment option which can improve their quality of life and
potentially modify the underlying cause of their
disease.
In Europe,
ACARIZAX® is indicated in adult patients
(18-65 years) diagnosed by a clinical history and by a positive
test for HDM sensitisation with at least one of the following
conditions:
- Persistent moderate to severe HDM allergic rhinitis despite
the use of symptom-relieving medication
- HDM allergic asthma not well controlled by inhaled
corticosteroids and associated with mild to severe HDM allergic
rhinitis and where patients' asthma status has been carefully
evaluated before initiation of
treatment.
About the Journal of the American Medical Association
(JAMA)
JAMA, published continuously since 1883, is an international
peer-reviewed general medical journal with the key objective of
promoting the science and art of medicine, and the betterment of
the public health. It is the most widely circulated medical journal
in the world, with more than 320,000 recipients of the print
journal, 1.2 million recipients of electronic tables of contents
and alerts, and nearly 15 million annual visits to the
journal's website. JAMA's reach
includes a growing social media presence (108,000 Twitter and
157,000 Facebook followers) and vast international news media
exposure, including more than 20 million viewers of the JAMA video
news report each week. JAMA's acceptance rate is 9.5% of the more
than 7,100 major manuscripts it receives annually and just 4% of
the more than 4,800 research papers received.