Takeda and Zinfandel Pharmaceuticals discontinue ‘TOMMORROW’ trial following planned futility analysis.
Takeda Pharmaceutical Company Limited and Zinfandel Pharmaceuticals, Inc. have discontinued the global Phase III TOMMORROW trial.
The decision to discontinue the trial was based on a planned interim futility analysis, which showed an inadequate treatment effect with the investigational drug pioglitazone 0.8 mg SR in delaying the onset of mild cognitive impairment (MCI) due to Alzheimer’s disease (AD). This decision was not related to safety of the investigational product or study procedures.
The TOMMORROW trial was investigating a genetic-based biomarker risk assignment algorithm (BRAA) as well as evaluating the safety and efficacy of investigational drug pioglitazone 0.8 mg SR in delaying the onset of MCI due to AD in cognitively normal individuals projected to be at high risk, as determined by the BRAA.
“We thank the commitment of the participants, investigators and clinical research personnel involved in the TOMMORROW trial for their invaluable contributions in the pursuit of advancing research in Alzheimer’s disease,” said Emiliangelo Ratti, head of Takeda’s neuroscience therapeutic area. “Takeda and Zinfandel will further analyze data from the trial, including the performance of the genetic-based biomarker risk assignment algorithm, with the hope that this information may ultimately help in the global fight against AD. Takeda remains committed to the discovery and development of potential treatments for AD.”
Results from the TOMMORROW trial will be presented at a future scientific meeting and efforts will be made to share the primary data with the scientific community.
(Source: Takeda Pharmaceutical Company Limited)
Filed Under: Drug Discovery
