ALK-Abello's experimental house dust mite allergy pill remains on track for a 2014 filing, after a second Phase III trial assessing its safety and efficacy achieved its targets.
The Danish drugmaker said top-line results of the Phase III MITRA trial showed that its therapy induced significant reductions in moderate to severe asthma exacerbations caused by the house dust mite.
It also said that tolerability was good and that the pill seems to have a "favourable safety profile", keeping it on track for regulatory submission in Europe next year.
House dust mites are the most common cause of allergy in the world, affecting 90 million people in Europe, North America and Japan, and more than 100 million in China. Nearly 50% of all house dust mite-allergic rhinitis patients suffer from concomitant asthma.
Back in June, ALK said data from the 992-patient Phase III MERIT trial showed its treatment significantly reduced symptoms and medication use in patients with house dust mite-induced allergic rhinitis.
According to ALK chief Jens Bager, taken together, results from the MITRA and MERIT trials represent "a major step forward in developing the first clinically documented allergy immunotherapy tablet for patients severely impacted by house dust mite-induced respiratory diseases experiencing poor control of their condition".
Across the Atlantic, ALK’s partner Merck & Co is currently performing a Phase IIb trial in the US, and has started preparations for a pivotal Phase III clinical trial to assess the drug as a treatment of house dust mite-induced rhinitis/rhinoconjunctivitis in adolescents and adults.