Date: 2014-06-09
Type of information: Presentation of results at a congress
phase: 3
Announcement: presentation of results at the 2014 Annual Congress of the European Academy of Allergy and Clinical Immunology (EAACI), in Copenhagen, Denmark.
Company: ALK (Denmark)
Product: Mitizax® (ALK HDM SLIT-tablet - immunotherapy tablet)
Action mechanism:
Disease: house dust mite induced hay fever and asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: Europe
Trial
details: The MERIT and MITRA trials are both Phase III, randomised, parallel-group, double-blind, placebo-controlled trials that will evaluate the efficacy and safety of Mitizax® given once daily compared to placebo in the treatment of house dust mite induced allergic rhinitis and allergic asthma, respectively.
The MERIT study is a Phase III, randomised, parallel-group, double-blind, placebo-controlled study and is intended to enrol 900 adult subjects across 86 centres in 12 European countries. The MERIT trial (MT-06) was initiated by ALK in 2011 to evaluate the efficacy and safety of the allergy immunotherapy tablet versus placebo in the treatment of house dust mite-induced allergic rhinitis. The primary endpoint of the trial was a reduction in the combined rhinitis symptom and medication score. The trial was a randomised, placebo-controlled, double-blind, multi-national, multi-centre trial. 992 patients from 12 European countries 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.
The MITRA study evaluates the efficacy and safety of the allergy immunotherapy tablet in the treatment of allergic asthma caused by house dust mites. Nearly 50% of all house dust mite allergic rhinitis patients suffer from asthma. The trial was a randomised, placebo-controlled, double-blind, multi-centre trial involving 834 patients from 13 European countries. Patients were divided into three treatment arms. Patients in 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 inhaled corticosteroids (ICS) until the last part of the trial, where the ICS usage was reduced by 50% for three months, and then completely withdrawn for another three months.
The MERIT and MITRA trials are part of the largest clinical development programme in the history of allergy immunotherapy, which has seen simultaneous development activities in both Europe and the world’s two largest pharmaceutical markets, Japan and the USA. Once completed, this programme will have involved more than 6,000 patients.
Latest
news: * On June 9, 2014, ALK 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.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. 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. ALK now expects to submit a regulatory filing to the European authorities in the second half of 2014. * On July 11, 2013, ALK has announced positive outcome of the second of two pivotal Phase III trials of its new allergy immunotherapy tablet for the treatment of house dust mite-induced respiratory diseases. The MITRA trial meets its primary endpoint and demonstrates a significant reduction in the risk of moderate-to-severe asthma exacerbations. The results demonstrate that the treatment significantly reduces patients' risks of moderate to severe asthma exacerbations. The results were statistically significant (p<0.05). The trial also demonstrated that the treatment was well tolerated and had a favourable safety profile. The MITRA trial (MT-04) was initiated by ALK in 2011 to evaluate the efficacy and safety of the allergy immunotherapy tablet compared to placebo in patients with house dust mite-induced asthma. 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. Further top-line data from the MITRA trial is expected to be presented in connection with the publication of ALK's six-month interim report (Q2) on 14 August 2013. "The successful outcome of the MERIT and MITRA trials keeps us on course for a European filing in 2014. It also provides positive news for our partners' parallel development programmes in North America and Japan, and increases our confidence that this innovative product will help fuel our future growth," says CEO Jens Bager, ALK. * On June 19, 2013, ALK has announced positive outcome of the first of two pivotal Phase III trials with its new allergy immunotherapy tablet for the treatment of house dust mite-induced respiratory diseases. The MERIT trial meets its primary endpoint and demonstrates that the new treatment has a significant clinical effect in allergic rhinitis. The results demonstrate that the treatment significantly reduces symptoms and medication use in patients with house dust mite-induced allergic rhinitis. The results were highly statistically significant (p<0.01). The trial also demonstrated that the treatment was well tolerated and had a favourable safety profile. The MERIT trial was designed to form a pivotal part of ALK's submission of a registration application in Europe. The new data allows for a filing in 2014; however, ALK will await the outcome of the on-going Phase III MITRA trial before submitting the registration application. ALK expects to report the outcome of the MITRA trial before end of Q3 2013. * On March 20, 2012, ALK has announced that all patients have been successfully recruited for two pivotal Phase III clinical trials (the so-called MERIT and MITRA trials) with Mitizax®, the new innovative allergy immunotherapy tablet against house dust mite induced hay fever and asthma. More than 1,700 patients have now been enrolled in the trials which are expected to be completed by mid-2013. Clinical development with Mitizax® is currently being conducted in Europe, North America and Japan. ALK is working with Merck & Co and Torii Pharmaceutical in North America and Japan, respectively. Its Japanese partner has recently initiated a phase I trial. * On September 26, 2011, ALK has announced that it is initiating an additional Phase III study (called the MERIT study) with Mitizax® in Europe aimed at broadening the therapeutic use of the product. The study is expected to be completed in 2013.
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.
