Date: 2015-06-04
Type of information: Initiation of the trial
phase: 3
Announcement: initiation of the trial
Company: Merck&Co (USA - NJ) ALK Abello (Denmark)
Product: HDM AIT (Mitizax® in Europe - immunotherapy tablet)
Action
mechanism: immunotherapy product
Disease: house dust mite-induced allergic rhinitis/rhinoconjunctivitis in children and adults
Therapeutic area: Allergic diseases - Immune diseases
Country: USA, Canada
Trial details:
Latest
news: * On June 4, 2015, ALK announced that its partner, Merck&Co has provided to ALK top-line results from a North-American Phase III clinical trial of ALK’s investigational sublingual allergy immunotherapy tablet (SLIT-tablet) for the treatment of house dust mite (HDM) allergic rhinitis. The trial demonstrated a statistically significant improvement in the primary endpoint in favour of HDM SLIT-tablet compared with placebo. The primary endpoint of the trial was to demonstrate a reduction in the ‘Total Combined Rhinitis Score’ (TCRS) which is the sum of the average daily rhinitis symptom score and the average daily medication score. The trial also showed that the treatment was generally well tolerated. The trial, a randomised, multi-centre, placebo controlled, double-blind, comparative trial, was initiated by Merck&Co in March 2014 to further investigate the safety and efficacy of the HDM SLIT-tablet in patients with HDM allergic rhinitis. It involved approximately 1,500 patients in the USA and Canada and is part of the world’s largest ever allergy immunotherapy development programme, which also includes trials in Europe and Japan. Merck&Co has informed ALK that they now plan to discuss the data and the plans for a regulatory submission of a Biological License Application (BLA) for the HDM SLIT-tablet with the FDA. Merck&Co also informed ALK that they will present the full trial results at a future scientific congress. The HDM SLIT-tablet is currently undergoing regulatory reviews in Europe and Japan based on a combined clinical development programme involving more than 4,000 patients, including the completion of two positive Phase III clinical trials for the treatment of HDM allergic rhinitis and one positive Phase III trial for the treatment of HDM allergic asthma. * On October 10, 2012, ALK has announced that its strategic partner, Merck & Co is planning to advance the clinical development programme for the house dust mite allergy immunotherapy tablet (HDM AIT) by initiating a Phase III clinical trial in North America. The trial is expected to include approximately 1,500 patients and will investigate the safety and efficacy of HDM AIT in the treatment of HDM-induced allergic rhinitis/rhinoconjunctivitis in children and adults. Merck anticipates that the study will initiate patient recruitment in 2013 and it is expected to complete in 2015. The Phase III trial in North America will be part of the largest development programme in the history of allergy immunotherapy. In Europe, ALK is currently conducting two clinical Phase III trials investigating safety and efficacy of HDM AIT in the treatment of HDM-induced allergic rhinitis and asthma, respectively. In Japan, HDM AIT has been licensed to Torii and is currently also in Phase II/III clinical development. Recently, Merck initiated a Phase IIb clinical trial for HDM AIT to evaluate dose-related effectiveness, safety and tolerability of HDM AIT. This trial is expected to enroll 120 patients and to complete in 2013.
Initiation of patient dosing in the Phase III trial in North America entitles ALK to an undisclosed milestone payment from Merck. This payment is currently expected to occur in 2013 at the earliest and consequently, this announcement does not lead ALK to change its financial outlook for the current year.
