OREANDA-NEWS. February 11, 2016. Takeda Pharmaceutical Company Limited (“Takeda”) [TSE: 4502] and its partner, Zinfandel Pharmaceuticals, Inc. (“Zinfandel”), today announced the completion of enrollment in the TOMMORROW trial, the largest Phase 3 trial of its kind.

TOMMORROW is a global Phase 3 clinical trial investigating a genetic-based biomarker risk assignment algorithm (BRAA) and evaluating the safety and efficacy of investigational drug pioglitazone 0.8 mg SR to delay the onset of mild cognitive impairment (MCI) due to AD in cognitively normal individuals projected to be at high risk, as determined by the BRAA.

The BRAA has three components: apolipoprotein E (APOE), Translocase of Outer Mitochondrial Membrane (TOMM40) genotypes and age. Increased age and certain APOE genotypes have previously been shown to indicate elevated risk of AD, but neither is sufficiently sensitive nor specific. The addition of TOMM40 genotype is hypothesized to further refine the risk determination.

Studies show that individuals with MCI are at an increased risk of developing AD or another dementia, with conversion rates of approximately 15 percent per year. No medication studied to date has been shown to reliably delay the onset of AD.

About the TOMMORROW Trial
TOMMORROW is a global, multicenter, randomized, double-blind, placebo-controlled, parallel-group trial. The trial is investigating a genetic-based BRAA to determine the risk of developing MCI due to AD within a five-year period in cognitively normal individuals between the ages of 65 to 83. It is also designed to evaluate the efficacy of the investigational agent, pioglitazone 0.8mg SR in delaying the onset of MCI due to AD in projected high-risk individuals, as determined by the BRAA. Approximately 3,500 subjects at over 50 centers throughout the United States, United Kingdom, Germany, Switzerland and Australia have been randomized into the trial. The trial duration is approximately five years or the time needed to achieve 202 conversions to MCI due to AD in the high-risk group.

For more information on the TOMMORROW trial, please visit: www.clinicaltrials.gov.

About Mild Cognitive Impairment (MCI) and Alzheimer’s Disease (AD)
AD is a degenerative brain disease characterized by a progressive decline in memory, thinking, comprehension, calculation, language, learning capacity and judgment sufficient to impair personal activities of daily living. In 2011, the U.S. National Institute on Aging (NIA) and the Alzheimer’s Association (AA) convened an expert panel to update the diagnostic guidelines for AD and also to develop criteria to define MCI due to AD and facilitate consensus in the field. Approximately 18 million Americans are currently suffering from AD, and the rate of occurrence doubles every five years for those between 65 and 85 years of age. In the 2010 World Alzheimer Report, Alzheimer’s Disease International estimated that there are 35.6 million people living with dementia worldwide in 2010, increasing to 65.7 million by 2030 and 115.4 million by 2050. 

About Takeda Pharmaceutical Company Limited
Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to strive towards better health for patients worldwide through leading innovation in medicine. Additional information about Takeda is available through its corporate website, www.takeda.com.

About Zinfandel Pharmaceuticals
Zinfandel Pharmaceuticals, based in Chapel Hill, NC, is a privately held company dedicated to using pharmacogenetics to improve prediction of risk for Alzheimer’s disease and thus facilitate the development of effective therapies.