Poor Results Prompt Takeda and Zinfandel to End Phase 3 Alzheimer’s Therapy Trial Early

Takeda Pharmaceutical Company and Zinfandel Pharmaceuticals have brought an early end to a Phase 3 clinical trial after their Alzheimer’s therapy pioglitazone failed to prevent the development of mild cognitive impairment.

The decision came less than a year after the partners completed enrollment in the TOMMORROW trial (NCT01931566).

An interim analysis of the study’s results showed that pioglitazone was unable to prevent people with normal cognition from developing the impairment seen in Alzheimer’s. Neither the drug’s safety nor the trial design played a role in the termination, the partners said.

“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,” Emiliangelo Ratti, the head of Takeda’s Neuroscience Therapeutic Area, said in a press release.

Researchers used a genetic-based biomarker risk assignment algorithm to identify cognitively normal people who were at high risk of developing the mild cognitive impairment seen in early Alzheimer’s cases. They then gave this group pioglitazone.

Previous studies had indicated that pioglitazone could be a potential treatment for dementia.

Ratti said “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 [Alzheimer’s]. Takeda remains committed to the discovery and development of potential treatments for AD.”

The trial data analysis may shed light on mechanisms that lead to Alzheimer’s, the partners said.

“This was a unique, groundbreaking opportunity,” said Ann Saunders, Zinfandel’s CEO. The partners expect 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 partners plan to make the trial results available to the scientific community and present them at conferences.