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March 10, 2014
| Torii Pharmaceutical Co., Ltd. |
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| Torii announces positive results for the Phase II/III Clinical Study of TO-203, an Allergen Immunotherapy Tablet for House Dust Mite Allergy |
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Today, Torii Pharmaceutical Co., Ltd. (TSE:4551) announced positive results for the Phase II/III clinical study of TO-203, an allergen immunotherapy tablet for house dust mite allergy, in patients with allergic rhinitis.
This is a randomized, multicenter, placebo-controlled, double-blind, comparative study to evaluate the efficacy and safety of TO-203 in patients with house dust mite-induced allergic rhinitis.
The study met its primary endpoint, providing statistically significant improvement in “Total Combined Rhinitis Score (TCRS)” compared to placebo, proving that sublingually administered TO-203 reduced symptoms of house dust mite-induced allergic rhinitis.
Furthermore, no specific finding was observed in tolerability or safety.
In parallel, another Phase II/III clinical study of TO-203 in patients with house dust mite-induced allergic asthma is also ongoing. Topline result of this study will be announced once it becomes available.
We will decide whether we would submit a New Drug Application for TO-203 in Japan based on the comprehensive review of the results from both studies in the future.
Torii holds the exclusive rights to develop and commercialize TO-203 in Japan, which were licensed from ALK-Abelló A/S in January 2011.
| About allergen immunotherapy |
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Allergen immunotherapy is a therapeutic method that the causative allergen of an allergic disease is administered at a low concentration/dose at first and is increased gradually in order to attenuate hypersensitivity to the allergen.
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| About house dust mite-induced allergic rhinitis/asthma |
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House dust mite-induced allergic rhinitis is a disease accompanied by nasal symptoms such as sneezing, rhinorrhea, nasal congestion, and nasal itching due to an allergy to house dust mites.
House dust mite-induced allergic asthma is a disease accompanied by chronic respiratory tract inflammation due to an allergy to house dust mites, as seen in the rhinitis type of allergy. If a person develops this disease, the respiratory tract becomes narrower than that of healthy people, making it difficult for air to flow through the airways. As a result, various respiratory symptoms such as coughing, sputum, difficulty in breathing, and wheezing may occur. If the symptoms aggravate, seizure-like respiratory symptoms may develop.
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| Total Combined Rhinitis Score |
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| The Total Combined Rhinitis Score (TCRS) is a total overall score of the Total Nasal Symptom Score (sum of the scores allocated as appropriate, depending on the severity of four symptoms: sneezing, nasal discharge, nasal obstruction, and nasal itching) and the Medication Score (sum of the scores allocated as appropriate, depending on the number of antihistaminic doses used to alleviate the symptoms of house dust mite-induced allergic rhinitis), and is used to measure the degree of improvement of allergic symptoms such as rhinitis. |
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