News Releases

January 05, 2021
Taiho Pharmaceutical Co., Ltd.

Taiho Pharmaceutical Begins Phase III Clinical Trial with Therapeutic Drug for Duchenne Muscular Dystrophy (TAS-205) in Japan

Taiho Pharmaceutical Co., Ltd. announced today that it has begun a phase III clinical trial in Japan with its therapeutic drug (development code: TAS-205) for Duchenne muscular dystrophy (DMD).

In December 2019, development of TAS-205 was selected as one of the 4th Cyclic Innovation for Clinical Empowerment (CiCLE) program for fiscal 2019, under the application title: Development of an innovative therapeutic drug for DMD with a novel mechanism of action originating from Japan by utilizing patient registry. This program is operated by the Japan Agency for Medical Research and Development (AMED). The new trial is a placebo-controlled multicenter double-blind comparative study for ambulatory DMD patients (REACH-DMD trial) in Japan. Eighty male DMD patients aged 5 years and older will be registered for this trial, with the purpose to study the efficacy and safety of TAS-205 by orally administering TAS-205 or a placebo twice daily for 52 weeks. For more information on this trial (NCT04587908/jRCT2041200055),

please visit: www.clinicaltrials.gov/

https://jrct.niph.go.jp/en-latest-detail/jRCT2041200055

(which is a system for disclosing clinical study implementation plans and research overviews).

TAS-205 (INN: pizuglanstat) is a selective hematopoietic prostaglandin D synthase (HPGDS) inhibitor discovered by Taiho Pharmaceutical. It is under development as a DMD treatment which can be used regardless of the dystrophin gene mutation type, controlling the decline in motor function in DMD patients by inhibiting HPGDS, which exacerbates the inflammatory response in DMD patients’ muscles.

Taiho Pharmaceutical will strive to make available TAS-205 as soon as possible, to patients and healthcare professionals fighting DMD, a disease strongly considered an unmet medical need.

About CiCLE

This program aims at creating a foundation (including human resources) for a radical transformation in the way research and development is conducted in response to needs arising in clinical settings and for accelerating the practical application to pharmaceutical products. It also seeks to drive the creation of an environment that strongly promotes the fostering of open innovation in the field of medical research and development through the combined efforts of government, academia, and the private sector.

About DMD (Duchenne muscular dystrophy)

DMD is a genetic disorder with a higher prevalence in young males. It is caused by a genetic mutation in a dystrophin gene, which codes a protein supporting the framework of muscle cells. It is a refractory, serious illness leading to a loss of muscle strength caused by the inability to produce normal dystrophin protein. The prevalence of DMD is 1.9 to 3.4 per 100,000 individuals, and there are an estimated 3,000 to 4,000 patients in Japan. At present, oral steroids and viltolarsen are the only drugs approved for DMD in Japan, and new treatment options are being awaited.

Information in this news release was current as of the original release date.

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