Date: 2016-04-27
Type of information: Results
phase: 2
Announcement: results
Company: Shionogi (Japan) Stallergenes Greer (UK)
Product: sublingual house dust mite and Japanese cedar pollen immunotherapy tablets (STAGR120)
Action
mechanism: immunotherapy product. In September 2010, Stallergenes signed exclusive partnership agreements with Shionogi for the clinical development, registration and commercialization of sublingual house dust mite and Japanese cedar pollen immunotherapy tablets. As part of this, the Company is eligible to development, regulatory and sales milestones, as well as royalty payments on net sales.
Disease: seasonal allergic rhinitis induced by Japanese Cedar pollen
Therapeutic area: Allergic diseases - Immunological diseases - Respiratory diseases
Country: Japan
Trial
details: The Primary efficacy endpoint was the Average Rhinoconjunctivitis Total Symptom Score (ARTSS) after four months of treatment. The ARTSS includes six symptom scores (sneezing, nasal discharge, nasal obstruction, itchy nose, watery eyes and itchy eyes).This was a randomized, double-blind, placebo-controlled, dose ranging trial in an environmental challenge chamber (EEC) to assess the efficacy and safety of Japanese Cedar Pollen sublingual immunotherapy tablets for the treatment of seasonal allergic rhinitis – the first ever in Japan. Patients aged 12 to 49 years with medical history consistent with Japanese Cedar Pollen-induced allergic rhinitis were eligible. A total of 330 patients were randomized to receive four months of treatment with Japanese Cedar Pollen sublingual immunotherapy tablets or placebo.
Latest
news: * On April 27, 2016, Stallergenes Greer, a biopharmaceutical company specializing in treatments for respiratory allergies, announced its partner, Shionogi reported positive results for the phase II clinical study of its sublingual immunotherapy tablet for the treatment of seasonal allergic rhinitis induced by Japanese Cedar pollen (STAGR120). Conducted in Japan, the study achieved its primary efficacy endpoint with all treated groups demonstrating a positive, statistically significant difference on the Average Rhinoconjunctivitis Total Symptom Score (ARTSS) versus the placebo group. Overall, the safety profiles were favorable. All active dose groups showed a significant reduction in the six nasal and ocular symptom score, compared to placebo. Local adverse reactions were observed, most of them were mild in severity. No unexpected adverse events were observed.
