Japanese Big Pharma Takeda and U.S. partner Zinfandel Pharmaceuticals have decided to give up and stop testing a 20-year-old diabetes medicine that they hoped could work as a new Alzheimer’s therapy.
The details from the brief update: The so-called "Tomorrow" trial has been pulled after the pair got their hands on a planned interim futility analysis, which showed that Actos (pioglitazone), already approved as a diabetes medicine (and as a generic), had an “an inadequate treatment effect […] in delaying the onset of mild cognitive impairment due to Alzheimer’s disease.”
Read: It didn’t work, although they added it had no safety issues.
RELATED: Takeda, Zinfandel double-team Alzheimer's biomarker
Pioglitazone, an insulin sensitizer of the thiazolidinedione class of peroxisome-proliferator activated receptor γ (PPARγ) agonists, has had safety issues outside of this test, however, being pulled in some European countries due to a potential increase in bladder cancer rates on those using it.
Some in the research community have for years now believed that anti-diabetes drugs could help stave off the effects of AD. Alzheimer’s U.K., a British-based charity, said “there is a connection between type 2 diabetes and Alzheimer's disease; people with type 2 diabetes are much more likely to develop Alzheimer's disease than healthy people of the same age group.”
In recent years, the Alz Forum noted that “PPARγ has come to be a target of interest for Alzheimer's drug development, both because of a general overlap of metabolic disease and Alzheimer’s disease risk factors and because cell-based and animal studies have implicated PPARγ, in particular, to play a role in neuroinflammatory processes in Alzheimer's and other neurodegenerative conditions.”
While tests will continue for other antidiabetics, including with Novo Nordisk’s GLP-1 analogue liraglutide, it seems that the Actos test will see no tomorrow.
“We thank the commitment of the participants, investigators and clinical research personnel involved in the Tomorrow 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.”
This comes amid a new report out this morning from IHS Markit and the Partnership to Fight Chronic Disease, who both project that the total cost of Alzheimer’s disease between 2017 and 2030 will be a staggering $7.7 trillion, which boils down to $3.2 trillion in healthcare costs and $4.5 trillion in the value of unpaid caregiving.