Results, Setbacks

Takeda and Zinfandel write off yet another Alzheimer’s PhIII after Actos fails a key interim test

Hours after Eli Lilly spelled out exactly how bad its last batch of Phase III data for solanezumab was, Takeda stepped up to say its big shot at proving that their diabetes drug Actos could also delay symptoms of Alzheimer’s was a complete flop.

Described as the biggest Phase III in Alzheimer’s to date when it was fully enrolled in early 2016, the TOMORROW study recruited more than 3,500 patients at 50 sites to test a low dose of Actos, using a genetic-based biomarker risk assignment algorithm from the small US biotech Zinfandel Pharmaceuticals, a Duke spinout, to identify the best subjects.

Zinfandel was founded by Allen Roses, a legendary Alzheimer’s researcher who first linked APOE and Alzheimer’s, later adding TOMM40 in the search for genetic triggers to the disease. He died in 2016, a few months after the Takeda study was fully enrolled.

At an interim point of the 5-year study the researchers say the treatment effect was too small to warrant any further work. There were no serious safety issues.

Emiliangelo Ratti

That all fits squarely into the pattern of disaster that has taken down virtually every pivotal study of the past 15 years, leaving patients with no therapeutic intervention aside from some early symptomatic relief from old drugs.

In just the last few weeks we’ve seen Pfizer bow out of Alzheimer’s and Parkinson’s work, while Axovant’s lead therapy failed a Phase III test. At this point, researchers are rethinking what they know about the disease and considering new approaches that may yet survive a research pathway littered with the wreckage of old programs that have crashed and burned.

Takeda, though, is definitely not joining the exodus. Neurosciences remains a key focus at the company, which just a few weeks ago executed a $1 billion-plus deal to ally itself with Denali, which has it own take on the genetics of Alzheimer’s and how that can play into new drug development programs.

Emiliangelo Ratti, head of Takeda’s neuroscience therapeutic area, 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. Takeda remains committed to the discovery and development of potential treatments for AD.


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