Clinical Trials

* On June 10, 2015, ALK announced that its partner, Merck&Co, has published positive results from a Phase II environmental exposure chamber trial evaluating the onset and dose-related efficacy of the house dust mite (HDM) sublingual allergy immunotherapy tablet (SLIT-tablet). The results appear in the latest printed edition of The Journal of Allergy and Clinical Immunology (JACI). The randomised, double-blind trial took place between October 2012 and August 2013 and enrolled 124 patients with HDM allergic rhinitis with or without conjunctivitis and with or without asthma. Over the course of 24 weeks, patients were treated daily with either a 12 developmental units (DU) or 6 DU dose of the HDM SLIT-tablet, or placebo. Before the trial began, and again after eight, 16 and 24 weeks of treatment, patients were exposed to HDM allergen using the Vienna Challenge Chamber – placing them in a room containing a precisely controlled HDM allergen load for six hours to induce an allergic response – and were asked to score their allergy symptoms every 15 minutes. The primary endpoint was the total nasal symptom score (TNSS). Total ocular symptoms score and asthma symptoms were also recorded.

By week 24, patients reported that the higher 12 DU dose HDM SLIT-tablet improved nose symptoms by 49%, and eye symptoms by 68%, compared with placebo. Nose and eye symptoms also improved with the 6 DU dose HDM tablet, but to a lesser extent. The most commonly reported side effects were mild-to-moderate throat irritation and temporary swelling of the mouth after dosing during the first weeks.

* On March 4, 2014, ALK's partner in North America, Merck &Co has presented new data from a Phase 2b trial with its investigational sublingual house dust mite allergy immunotherapy tablet at the annual meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego, USA. The trial results showed that both doses of active treatment significantly reduced the average total nasal symptom score compared to placebo in adults with house dust mite-induced allergic rhinitis.  The study was conducted in 124 adult patients 18 years of age and older with house dust mite-induced allergic rhinitis, with or without conjunctivitis, using an environmental exposure chamber. In the study, MK-8237 at once-daily doses of 6 Development Units (DU) and 12 DU produced a significant dose- and time-dependent reduction in average total nasal symptom score (TNSS) over the last four hours of the chamber challenge at week 24 of treatment compared to placebo (-27%=6 DU, -49%=12 DU; pMK-8237 demonstrated dose-dependent reductions versus placebo in average TNSS at week 8 (-8%=6 DU; p=NS and -20%=12 DU; p<0.05) and at week 16 (-18%=6 DU, -30%=12 DU; p<0.05). In this study, the most common adverse events occurring in patients receiving MK-8237 6 DU, 12 DU or placebo, respectively, were throat irritation (34%, 52%, 0%), mouth edema (24%, 24%, 0%), lip swelling (5%, 17%, 2%), oral pruritus (15%, 14%, 0%), dyspepsia (2%, 10%, 0%), ear pruritus (0%, 7%, 0%), swollen tongue (0%, 5%, 0%), oropharyngeal swelling (0%, 5%, 0%) and pharyngeal edema (2%, 5%, 0%). There were no local swellings of severe intensity and no serious adverse events reported in patients treated with MK-8237. The majority of adverse events in this study were assessed as mild or moderate. There were no investigator reported systemic allergic reactions or reactions treated with epinephrine for either dose of MK-8237.