Date: 2014-03-10
Type of information: Initiation of preclinical development
phase: 2-3
Announcement: results
Company: ALK Abello (Denmark) Torii Pharmaceutical (Japan)
Product: Mitizax® (immunotherapy tablet)
Action
mechanism: immunotherapy product
Disease: house dust mite induced hay fever and asthma
Therapeutic area: Allergic diseases - Inflammatory diseases - Respiratory diseases
Country: Japan
Trial
details: The two trials will include approximately 1,800 subjects and will investigate safety and efficacy of Mitizax® in the treatment of house dust mite induced allergic rhinitis and asthma in a Japanese population.
Latest
news: * On July 31, 2012, ALK has announced that its strategic partner, Torii, is advancing the clinical development programme for Mitizax® by initiating two parallel Phase II/III trials in Japan. The two Phase II/III trials in Japan are part of the largest development programme in the history of allergy immunotherapy. In Europe, ALK is currently conducting two similar clinical Phase III trials which will complete in 2013. In North America, Mitizax® has been licensed to Merck (known as MSD outside the USA and Canada) and is currently in Phase II clinical development. * On September 26, 2011, ALK has announced that its strategic partner, Torii, has begun the clinical development programme with Mitizax® and initiated a Phase I study in Japan. Mitizax® is ALK’s new innovative allergy immunotherapy tablet (AIT) against house dust mite induced hay fever and asthma. The Phase I study will include approximately 50 subjects and is intended to investigate safety and tolerability of Mitizax® in a Japanese population. The initiation releases a milestone payment to ALK and full-year outlook is adjusted upwards. In January 2011, ALK and Torii entered into an exclusive license agreement to develop, register and commercialise ALK’s house dust mite allergy immunotherapy products for asthma and allergic rhinitis in Japan. * On June 16, 2014, ALK announced that its partner for Japan, Torii Pharmaceutical Co has completed its second of two Phase II/III trials into ALK’s sublingual allergy immunotherapy tablet (SLIT-tablet) for the treatment of house dust mite (HDM)-induced respiratory diseases.
Torii initiated the trial in 2012 as a randomised, multi-centre, placebo-controlled, double-blind comparative trial, looking at both the safety and efficacy of the drug in patients with house dust mite-induced allergic asthma. While the trial confirmed that the treatment was well tolerated by patients, with no new or unexpected findings reported, the trial did not meet the primary efficacy endpoint of showing a statistically significantly lower risk of moderate to severe asthma exacerbations when compared with patients who received placebo. A parallel trial, investigating the safety and efficacy in HDM-induced allergic rhinitis was successfully completed in March 2014 and met its primary efficacy endpoint. In all, approximately 1,800 patients have participated in the two Japanese clinical trials.
Torii will now seek to discuss the trial results, along with relevant supportive documentation from ALK's European development programme, with the Japanese health authorities. Based on the available data, Torii expects to submit a registration application to the authorities within the next six-to-ten months.
Torii’s two trials were similar in design to ALK’s successfully completed European trials. ALK targets a regulatory filing for the house dust mite SLIT-tablet in H2 2014 in Europe.* On March 10, 2014, ALK has announced that its partner for Japan, Torii Pharmaceutical Co., Ltd., has reported positive results from its Phase II/III trial into ALK's sublingual allergy immunotherapy tablet (SLIT-tablet) for house dust mite-induced allergic rhinitis (hay fever). The trial met its primary efficacy endpoint by showing a significantly lower ‘Total Combined Rhinitis Score' (TCRS) when compared with patients who received placebo. The trial also showed that the treatment was well tolerated and had a favourable safety profile.The trial was initiated by Torii in 2012 as a randomised, multi-centre, placebo-controlled, double-blind comparative trial, looking at both the safety and efficacy of the drug in patients with house dust mite-induced allergic rhinitis. A second, parallel trial, looking at safety and efficacy in house dust mite-induced allergic asthma, was initiated at the same time and is expected to report in the coming months. In all, approximately 1,800 patients participated in the two trials, the results of which will determine whether Torii will submit a New Drug Application in Japan.
Initiation of patient dosing in the Phase II/III trials in Japan entitles ALK to an undisclosed milestone payment from Torii. This payment has already been included in ALK’s financial outlook for 2012.
