Takeda Pharmaceutical Co., Ltd. and its partner, Zinfandel Pharmaceuticals, Inc. announced that the global Phase III TOMMORROW trial has been terminated. 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.
“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.”
“While we are extremely disappointed with the interim futility outcome and the decision to terminate conduct of the TOMMORROW study, we are deeply grateful to the dedicated study participants, project partners, investigators, site personnel, independent committees, and study teams for their unwavering commitment over these past four years”, said Ann Saunders, Chief Executive Officer of Zinfandel Pharmaceuticals. “This was a unique, groundbreaking opportunity, and the volume and quality of clinical data generated by TOMMORROW will provide valuable insights into the earliest stages of the AD process and contribute to easing the burden of AD.”
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. 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.
Filed Under: Drug Discovery