Date: 2015-08-07
Type of information: Results
phase: 2-3
Announcement: results
Company: ALK Abello (Denmark) Torii Pharmaceutical (Japan)
Product: sublingual immunotherapy tablet (SLIT-tablet)
Action
mechanism: immunotherapy product
Disease: Japanese cedar tree pollen allergy
Therapeutic area: Allergic diseases - Immunological diseases
Country: Japan
Trial details:
Latest
news: * On August 7, 2015, ALK announced that its partner for Japan, Torii Pharmaceutical 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). 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 favourable safety profile. The randomised, 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. Torii will now proceed with the preparations for a submission of a New Drug Application (NDA)to the Japanese Ministry of Health, Labour and Welfare. * On September 2, 2014, ALK announced that its strategic partner, Torii, has advanced the clinical development programme for the Japanese cedar tree pollen sublingual immunotherapy tablet (SLIT-tablet) and initiated a Phase II/III clinical trial in Japan. The trial is expected to include approximately 1,000 subjects and will investigate safety and efficacy of the SLIT-tablet in the treatment of Japanese cedar tree pollen-inducertnd allergic rhinitis. In addition, Torii is currently finalising the development of ALK\'s house dust mite SLIT-tablet and is expected to submit a registration application to the Japanese authorities within six months. ALK’s partnership with Torii covers the development, registration and commercialisation of SLIT-tablets against house dust mite-induced allergy. It also covers ALK’s existing SCIT product against house dust mite allergy, diagnostics and the development of a SLIT-tablet against Japanese cedar pollen allergy. Japan is the second largest pharmaceutical market in the world where an estimated 25-35 million people suffer from allergy caused by Japanese cedar tree pollen or house dust mites.
