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June 16, 2014
| Torii Pharmaceutical Co., Ltd. |
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| Torii announces results for the Phase II/III Clinical Study (asthma) of TO-203, an Allergen Immunotherapy Tablet for House Dust Mite Allergy |
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Today, Torii Pharmaceutical Co., Ltd. (TSE:4551) announced results for the Phase II/III clinical study of TO-203, an allergen immunotherapy tablet for house dust mite allergy, in patients with allergic asthma.
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 asthma. While no specific finding was observed in tolerability or safety, the study did not meet its primary endpoint with statistically significant difference compared to placebo. Torii will conduct further review of the results and consider our future plans.
As Torii announced on March 10, 2014, positive results were obtained from the Phase II/III clinical study of TO-203 in patients with house dust mite-induced allergic rhinitis. We will proceed with the preparations for submission of a New Drug Application of TO-203 for the above rhinitis indication in Japan based on the available data.
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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