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Alk Abello A/S' Partner Merck & Co Inc Plans to Initiate Phase III Clinical Trial with HDM AIT in North America


Wednesday, 10 Oct 2012 08:47am EDT 

Alk Abello A/S announced that its strategic partner Merck & Co Inc (knowns as MSD outside the United States and Canada) is planning to advance the clinical development program for the house dust mite allergy immunotherapy tablet (HDM AIT) by initiating a Phase III clinical trial in North America. HDM AIT is ALK's new AIT against HDM-induced hay fever and asthma. 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. In Europe, ALK is conducting two clinical Phase III trials investigating safety and efficacy of HDM AIT (MITIZAX) in the treatment of HDM-induced allergic rhinitis and asthma, respectively. In Japan, HDM AIT has been licensed to Torii and is 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 payment from Merck. This payment is expected to occur in 2013 at the earliest.