The FINANCIAL — Takeda Pharmaceutical Company Limited and its partner, Zinfandel Pharmaceuticals, Inc. on February 10 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, according to Takeda.
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.