Updated on 10 August 2015
Copenhagen-based ALK has announced that its partner in Japan, Torii Pharmaceutical Co Ltd, has reported positive results from its phase II/III trial into a sublingual allergy immunotherapy tablet (SLIT-tablet) for Japanese cedar tree pollen allergic rhinitis (hay fever).
ALK indicates that the trial met its primary efficacy endpoint providing statistically significant improvement in the 'Total Combined Rhinitis Score' (TCRS) compared with patients who received placebo, demonstrating that the SLIT-tablet reduced symptoms of Japanese cedar pollen allergic rhinitis. The trial also showed that the treatment was well tolerated and had a favorable safety profile.
Commenting on the results, ALK's President and CEO Jens Bager said, "These results mark another step on our journey towards globalizing ALK's portfolio of SLIT-tablets. Our partnership with Torii continues to progress rapidly and we are getting closer to the launch of these products in the world's second largest pharmaceutical market."
The randomized, placebo-controlled, double-blind, comparative trial, which included approximately 1,000 subjects, was initiated in 2014 to investigate the safety and efficacy of the SLIT-tablet in patients with Japanese cedar tree pollen allergic rhinitis.
With these positive results, Torii intends to submit a New Drug Application to the Japanese Ministry of Health, Labour and Welfare.