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  • Kissei Announces the Publication of the Results of Phase III Clinical Trials of Rovatirelin for the Treatment of Spinocerebellar Degeneration in the Journal of Neurology, Neurosurgery, and Psychiatry

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January 22, 2020

Kissei Announces the Publication of the Results of Phase III Clinical Trials of Rovatirelin for the Treatment of Spinocerebellar Degeneration in the Journal of Neurology, Neurosurgery, and Psychiatry

Kissei Pharmaceutical Co., Ltd. (Chairman and CEO: Mutsuo Kanzawa; hereinafter referred to as "Kissei") announced today that the results of two phase III clinical trials of rovatirelin discoverd by Shionogi & Co., Ltd. (President & CEO: Isao Teshirogi, Ph.D.) for the treatment of spinocerebellar degeneration have recently been published in a medical journal, the online version of the Journal of Neurology, Neurosurgery, and Psychiatry*.

Kissei conducted an initial phase III clinical trial of rovatirelin from 2013 to 2015. Based on the results of the initial phase III clinical trial, Kissei conducted an additional phase III clinical trial starting from 2016 to 2018. The primary endpoint of these trials was the mean change from baseline in total SARA score for the assessment of ataxia. However, a statistically significant difference from the placebo-controlled group was not determined.

In this paper, to review the results of both phase III clinical trials, a pooled (post hoc) analysis was performed with patients who met the inclusion criteria for the additional phase III trial, which comprised patients with a more severe condition. The change in total SARA score in the rovatirelin 2.4 mg group indicated a statistically significant improvement compared with the placebo group (a 1.64-point improvement in the rovatirelin 2.4 mg group and a 1.03-point improvement in the placebo group). With regard to safety, it was reported that the most common adverse events (5% or more) in the rovatirelin group were nasopharyngitis, nausea, weight decreased, and contusion; most were mild in severity.

Based on the results of these analyses, Kissei is still under discussion about the future process with the Japanese Pharmaceuticals and Medical Devices Agency.

Rovatirelin has not yet been approved for the treatment of spinocerebellar degeneration.


* Nishizawa M, Onodera O, Hirakawa A on behalf of the Rovatirelin Study Group, et al. Effect of rovatirelin in patients with cerebellar ataxia: two randomised double-blind placebo-controlled phase 3 trials.
Journal of Neurology, Neurosurgery & Psychiatry Published Online First: 14 January 2020. doi: 10.1136/jnnp-2019-322168

https://jnnp.bmj.com/content/early/2020/01/21/jnnp-2019-322168




《Reference》

About KPS-0373 (generic name: rovatirelin):

Rovatirelin is a derivative of thyrotropin-releasing hormone (TRH) discovered by Shionogi & Co., Ltd. It activates the nervous system by promoting the release of acetylcholine and monoamine neurotransmitters such as dopamine after binding to TRH receptors distributed in the central nervous system, and is expected to improve the ataxias in patients with spinocerebellar degeneration.

About spinocerebellar degeneration:

Spinocerebellar degeneration is a nerve degeneration disorder of unknown etiology in which symptoms such as ataxia appear owing to the degeneration of the cerebellum or spinal cord. It is designated as an intractable disease by the Ministry of Health, Labour and Welfare, with 30,000 or more patients certified with this condition in Japan. Although the pathogenesis has been investigated by recent basic research, many aspects remain unclear and there is no definitive treatment. Therefore, symptomatic treatment is currently performed. The "Survey of Medical Needs on Neurologic Diseases" conducted in cooperation with the Japan Health Sciences Foundation and the Japan Society of Neurological Therapeutics reported that spinocerebellar degeneration is a "disease for which development of new therapies is urgent" for the following reasons: low treatment satisfaction, low availability of drugs, and the absence of effective treatment.

About SARA (Scale for the Assessment and Rating of Ataxia):

It is a semi-quantitative method for the assessment of ataxia in spinocerebellar degeneration and other similar conditions; it consists of eight categories (gait, stance, sitting, speech disturbance, finger chase, nose-finger test, fast alternating hand movements, and heel-shin slide) and is used internationally. The scores from the eight categories are summed, with a maximum score of 40; 0 indicates no symptoms and 40 indicates the most severe symptoms.