Merck Announces Results from Phase IIb Study of an Investigat?ional House Dust Mite Sublingual Allergen Immunother?apy Tablet

Merck, known as MSD outside the US and Canada, has announced results from a Phase IIb study evaluating two doses of its investigational house dust mite sublingual immunotherapy tablet (MK-8237).

The data were presented for the first time during a late-breaking oral session at the 2014 Annual Meeting of the American Academy of Allergy, Asthma & Immunology (AAAAI) in San Diego.  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) during the last four hours of the chamber challenge at week 24 of treatment compared to placebo (-27%=6 DU, -49%=12 DU; p<0.05 for both vs. placebo), the primary efficacy endpoint of the study. TNSS is the total score for four nasal symptoms: itchy nose, blocked nose, runny nose and sneezing.  

“Merck is committed to the research and development of sublingual tablet immunotherapy options for the treatment of allergic rhinitis,” said Dr Sean Curtis, vice president, Respiratory and Immunology, Merck Research Laboratories. “We look forward to continuing with Phase III research, which will provide further insight into the safety and efficacy of MK-8237.”