May 30, 2018
Kissei Announces Negative Topline Results from the additional phase III Clinical Trial evaluating "KPS-0373 (Development Code)" for the Treatment of Spinocerebellar Ataxia
Kissei Pharmaceutical Co., Ltd. [Head Office: Matsumoto-city, Nagano, Japan; Chairman and CEO: Mutsuo Kanzawa (hereinafter referred to as "Kissei")] today announced negative topline results of the additional phase III clinical trial of the investigational drug for the treatment of spinocerebellar ataxia under development (Development Code: KPS-0373). The primary endpoint of the trial was the mean change from baseline in SARA score for the assessment of ataxia, it did not demonstrate statistically significant difference from placebo.
Kissei will decide upon the appropriate future course of action with respect of KPS-0373, after we assess the results in detail including sub-group analysis based on severity.
This result will not impact on the company's financial results for the fiscal year ending March 31, 2019.
About Spinocerebellar Ataxia: Spinocerebellar ataxia is a neurodegenerative disease of unknown etiology with the manifestation of symptoms including ataxia due to cerebellar or spinal degeneration. It has been designated as an intractable disease by the Ministry of Health, Labour and Welfare, and there are 30,000 or more recognized patients in Japan.
About SARA (Scale for the assessment and rating of ataxia) : The SARA is a tool for assessing ataxia. It has 8 categories with accumulative score ranging from 0 (no ataxia) to 40 (most severe ataxia). When completing the outcome measure each category is assessed and scored accordingly. Scores for the 8 categories as follows: 1.Gait, 2.Stance, 3.Sitting, 4.Speech disturbance, 5.Finger chase, 6.Nose-finger test, 7.Fast alternating hand movement, 8.Heel-shin slide.