ALK Presents Phase III Data on House Dust Mite SLIT-tablet at EAACI Annual Congress in Copenhagen

PR56984

HORSHOLM, Denmark, June 9, 2012 /PRN=KYODO JBN/ --

    First sublingual allergy immunotherapy tablet with robust results in

allergic rhinitis and allergic asthma. Data supports European regulatory filing

in 2H 2014

    Today, ALK (ALKB:DC / OMX: ALK B / AKABY / AKBLF) has presented key trial

results on its new sublingual allergy immunotherapy tablet (SLIT-tablet) for

house dust mite (HDM) respiratory allergic diseases at the 2014 Annual Congress

of the European Academy of Allergy and Clinical Immunology (EAACI), in

Copenhagen, Denmark.

    The ALK HDM SLIT-tablet works by addressing the underlying causes of HDM

respiratory allergic diseases. It is the first allergy immunotherapy product

with a comprehensive clinical development programme aimed at treating both

upper and lower airway manifestations of HDM induced allergic respiratory

diseases (namely allergic rhinitis and allergic asthma, respectively).

    Together, the MITRA and MERIT trials involved more than 1,800 patients. The

trials form part of the largest clinical development programme in the history

of allergy immunotherapy, involving more than 5,000 patients from Europe, North

America and Japan.

    MITRA trial in allergic asthma

    The MITRA trial (MT-04) was initiated by ALK in 2011 to evaluate the

efficacy and safety of the HDM SLIT-tablet compared to placebo in patients with

HDM-induced asthma not fully controlled with medium to high dose inhaled

corticosteroid (ICS). The primary endpoint of the trial was reduction in the

risk of moderate-to-severe asthma exacerbation during ICS reduction as measured

by the time to the first exacerbation.

     The MITRA trial met its primary clinical endpoint. Patients who received

the dose of 12 SQ-HDM experienced a significant improvement in their asthma

control as evident by a 34% reduction in risk of suffering a moderate-to-severe

asthma exacerbation during the withdrawal of inhaled corticosteroids.

    Furthermore, the risk of patients experiencing nocturnal awakenings due to

their asthma was significantly reduced in the observation period immediately

preceding as well as after ICS withdrawal with the 12 SQ-HDM dose.

    At randomisation, 28% of patients had uncontrolled asthma, according to the

Global Initiative for Asthma (GINA) control assessment criteria, despite using

medium to high dose ICS. The safety profile for uncontrolled patients was

consistent with that of the general population with no increased risk

identified. This finding may be of high clinical significance as uncontrolled

asthma is considered a contraindication to presently available allergy

immunotherapy products.

    MERIT trial in allergic rhinitis

    The MERIT trial was initiated by ALK in 2011 to evaluate the efficacy and

safety of the HDM SLIT-tablet compared to placebo in the treatment of

HDM-induced allergic rhinitis. The primary endpoint of the trial was a

reduction in the combined rhinitis symptom and medication score.

    Patients selected for the trial had all been diagnosed with

moderate-to-severe HDM-induced allergic rhinitis and were highly symptomatic

and requiring regular pharmacotherapy prior to receiving treatment. These

symptoms were associated with sleep disturbance, impairment of daily activities

or impairment of school or work.

    The MERIT trial met its primary clinical endpoint. The median combined

rhinitis symptom and medication score was reduced by 22% in patients treated

with the 12 SQ-HDM dose versus placebo. Furthermore, patients experienced

significantly fewer days with rhinitis exacerbation (defined as a day with

severe rhinitis symptoms). The risk of experiencing a day with rhinitis

exacerbation was halved, equating on average to approximately 20 fewer days

annually with severe rhinitis symptoms.

    The phase 2 and 3 data presented demonstrated an onset of action with the

12 SQ-HDM dose as early as 8 to 14 weeks post initiation of treatment.

    Both the MITRA and MERIT trials also demonstrated that the treatment was

well tolerated and had a favourable safety profile.

    European regulatory filing on schedule

    Henrik Jacobi, Executive Vice President, Research & Development at ALK,

said: "These trials show very positive results for ALK's new SLIT-tablet in

treating both manifestations of house dust mite-induced respiratory allergic

diseases - allergic rhinitis and allergic asthma. They show that this new

treatment could reduce allergy symptoms so that moderate-to-severe cases become

mild. Based on these findings, we expect to submit a regulatory filing to the

European authorities in the second half of 2014."

    Professor Pascal Demoly, Head of the Respiratory & Allergy Department at

the University Hospital of Montpellier and Principal Investigator on the MERIT

trial, said: "This is the first time we have seen robust data on the use of

allergy immunotherapy for the treatment of both HDM allergic rhinitis and

allergic asthma."

    He continued: "The HDM SLIT-tablet can be an important new treatment option

for doctors involved in the management of patients with HDM respiratory

allergic diseases whose condition is not well controlled by existing

pharmacotherapy. For patients, it offers hope of relief from the burden of

chronic respiratory allergy, and a potential release from the constant need to

take symptomatic medication."

    ALK-Abello A/S

    For further information please contact:

    Press:

    Martin Barlebo,

    tel. +45-4574-7901,

    mobile +45-2064-1143

    Investor Relations:    

    Per Plotnikof,

    tel. +45-4574-7527,

    mobile +45-2261-2525

    About ALK

    ALK is a research-driven global pharmaceutical company focusing on allergy

prevention, diagnosis and treatment. ALK is the world leader in allergy

immunotherapy - a unique treatment of the underlying cause of allergy. The

company has approximately 1,800 employees with subsidiaries, production

facilities and distributors worldwide. ALK has entered into partnership

agreements with Merck and Torii to commercialise sublingual allergy

immunotherapy tablets in North America and Japan, respectively. The company is

headquartered in Horsholm, Denmark, and listed on NASDAQ OMX Copenhagen. Find

more information at http://www.alk.net.

    About the MITRA trial

    The trial was a randomised, placebo-controlled, double-blind,

multi-national, multi-centre trial involving 834 patients from 13 European

countries. Patients were divided into three treatment arms. Patients from the

first two groups received two different doses of the tablet, while patients in

the third group received placebo. Patients were dosed once daily for up to 18

months. Additionally, all patients received treatment with ICS until the last

part of the trial, when ICS usage was reduced by 50% for three months, and then

completely withdrawn for another three months. The trial design and success

criteria were discussed with the European Medicines Agency (EMA) as scientific

advice prior to trial initiation.

    About the MERIT trial

    The trial was a randomised, placebo-controlled, double-blind,

multi-national, multi-centre trial involving 992 patients from 12 European

countries. Patients were divided into three treatment arms of equal size.

Patients in the first two groups received two different doses of the tablet,

while patients in the third group received placebo but had unrestricted access

to symptom-relieving medication. The patients received treatment once daily for

one year.

    About house dust mite allergy

    House dust mites are the most common cause of allergy in the world.

HDM-induced 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 up to 20% are facing moderate to severe symptoms. The condition appears

early in life, is present all year round and patients face an elevated risk of

developing asthma and other allergies.  

    SOURCE: ALK