Takeda, Zinfandel's AD test fails to deliver

Takeda Pharmaceutical Co. Ltd. (Tokyo:4502) and partner Zinfandel Pharmaceuticals Inc. (Durham, N.C.) discontinued the Phase III TOMMORROW trial of 0.8 mg pioglitazone (AD-4833) after a planned interim futility analysis showed that the compound was inadequate on the primary endpoint of delaying the onset of mild cognitive impairment (MCI) due to Alzheimer’s disease in high-risk patients. The partners said the decision was not related to safety.

The five-year, double-blind, international trial enrolled over 3,500 cognitively normal individuals and used a genetic-based biomarker risk assignment algorithm to determine the risk of developing MCI due to AD within five years. The algorithm has three components: apolipoprotein E (APOE) genotype, translocase of outer mitochondrial membrane 40 homolog (TOMM40; TOM40) genotype and age. Takeda has exclusive, worldwide rights to develop and commercialize Zinfandel’s TOMM40 assay, including in combination with pioglitazone, to determine risk of AD (see BioCentury, Jan. 17, 2011)...