PHASE II CLINICAL TRIAL FOR THE ALZHEIMER’S DISEASE DRUG “T-817MA” COMMENCED IN JAPAN
Also commenced a joint phase II clinical trial in the United States with an Alzheimer's disease therapeutic research consortium
TOKYO, JAPAN, June 9, 2014 – FUJIFILM Holdings Corporation is to accelerate the development of the Alzheimer’s disease drug “T-817MA” following the commencement of a Phase II clinical trial in late May by its group company, Toyama Chemical, in Japan. In the United States, FUJIFILM Corporation entered into a partnership with the Alzheimer’s Disease Cooperative Study (hereinafter “ADCS”),(*1) the largest Alzheimer’s disease therapeutic research consortium in the United States, to start a joint phase II clinical trial(*2) in June.
The number of dementia patients is estimated to be 44 million worldwide, and the figure is projected to reach 76 million by 2030. More than half of them suffer from Alzheimer’s disease, and the trend is set to continue. The drugs currently available in the market for treating Alzheimer’s disease include acetylcholinesterase inhibitors, such as donepezil hydrochloride. Since these drugs merely address the deficit in neurotransmission to give temporary improvement to the patients' symptoms, there has been a strong call for the development of a new class of therapies to treat Alzheimer's Disease.
T-817MA is an Alzheimer’s disease drug discovered by Toyama Chemical. It offers powerful protection for neurons, promotes neurite outgrowth, and has demonstrated strong efficacy in animal models.
In Japan, Toyama Chemical launched a phase I clinical trial in 2012, confirming the safety and tolerability of the T-817MA. In order to examine T-817MA's efficacy and dose response, they moved on to a phase II clinical trial, in late May, on Alzheimer patients being treated with donepezil hydrochloride. In the United States last year, Fujifilm decided to conduct a phase II clinical trial jointly with the ADCS, which has extensive experience in the field of Alzheimer's Disease therapeutic research. The phase II clinical trial began in June this year, using the same method and dosage adopted in the Japanese trial. The development of T-817MA will continue to be promoted under a clinical trial structure using the same methodology and dosage in both Japan and the United States.
There are high expectations for T-817MA as a revolutionary therapy that could deliver a high level of treatment efficacy to Alzheimer's disease sufferers, who are rapidly increasing in our aging society. The Fujifilm Group is committed to further accelerating the development of T-817MA through joint research with the Kyoto University Center for iPS Cell Research and Application, in which patient-derived iPS cells are used to identify biomarkers that can predict the efficacy of the T-817MA.
*1 ADCS is a clinical trials consortium, established and supported by the National Institute on Aging, part of the National Institutes of Health, with the aim of evaluating Alzheimer’s disease interventions. It is led by Dr. Paul Aisen, one of the leading authorities in the field of Alzheimer's disease in the United States. The Consortium is based at the University of California San Diego (CA).
*2 The clinical trial is carried out by Toyama Chemical and the ADCS.
Fujifilm Holdings Corporation
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FUJIFILM Corporation Pharmaceutical Products Division