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August 7, 2015
| Torii Pharmaceutical Co., Ltd. |
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Torii announces positive results for the Phase II/III Clinical Study of TO-206,
an Allergen Immunotherapy Tablet for Japanese Cedar Pollinosis |
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Torii Pharmaceutical Co., Ltd. (TSE:4551) announced today positive results for the Phase II/III clinical study of TO-206, an allergen immunotherapy tablet for Japanese cedar pollinosis.
This is a randomized, placebo-controlled, double-blind, comparative study to evaluate the efficacy and safety of TO-206 in patients with Japanese cedar pollinosis.
The study met its primary endpoint, providing statistically significant improvement in "Total Combined Rhinitis Score (TCRS)" compared to placebo, proving that sublingually administered TO-206 reduced symptoms of Japanese cedar pollinosis.
Furthermore, no specific finding was observed in tolerability or safety.
Torii has been pursuing clinical development of TO-206 which is expected improved convenience of use such as storage at room temperature as compared to "CEDARTOLEN® SUBLINGUAL DROP - Japanese Cedar Pollen", a sublingual immunotherapy drug for Japanese cedar pollinosis, launched in October 2014.
Torii will proceed with the preparations for submission of a New Drug Application of TO-206 to the Japanese Ministry of Health, Labour and Welfare.
| Japanese cedar pollinosis |
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Japanese cedar pollinosis collectively refers to an allergic disease caused by Japanese cedar pollen. Patients with Japanese cedar pollinosis have excessive immunological reaction to Japanese cedar pollen and develop sneezing, nasal discharge, nasal occlusion, itchiness of the eyes, and runny eyes among other symptoms.
According to a nationwide survey, about 20% of Japanese people have pollinosis and about 70% of them have Japanese cedar pollinosis.
(A FY 2010 MHLW-subsidized research program for prophylaxis/treatment of immunological allergic diseases, "Research for Correct Treatment of Pollinosis")
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| Allergen immunotherapy |
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Allergen immunotherapy is a therapeutic method of administering the causative allergen of an allergic disease at a low dose at first and then an increased dose in order to reduce hypersensitivity to the allergen and has following characteristics.
●Alleviation of allergy symptoms and long-term remission are expected.
●Prior to commencement of treatment, a definitive diagnosis of causative allergen is necessary.
●Long-term treatment (3 – 5 years) is required.
●Efficacy is expected on not all of the patients.
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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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