Alzheimer’s Drug Development: An Avant-Garde Approach

Originally published on MedCityNews.com.

Originally published on MedCityNews.com.

A handful of high-profile Alzheimer’s disease drugs have failed in late-stage clinical trials in the last year — at least two of them based on the hypothesis that buildup of amyloid plaques in the brain give rise to neurodegeneration. Startup T3D Therapeutics Inc. thinks that warrants a different approach to a disease-altering therapeutic.

“Alzheimer’s disease involves multiple abnormalities, yet the pharmaceutical industry has placed heavy bets on developing treatments for just one abnormality,” said founder and CEO John Didsbury.

T3D claims it’s developing a drug with the potential to address several disease pathologies, including beta-amyloid plaque issues, inflammation, neuronal cell loss, neurotransmitter deficits, insulin deficiency and tau neurofibrillary tangles. And it would come in the form of a once-a-day pill for people with mild to moderate Alzheimer’s.

The Durham, North Carolina company licensed its technology from specialty pharmaceutical company DARA BioSciences, where Didsbury formerly served as president and chief operating officer. DARA had developed the drug candidate, now called T3D-959, through Phase I clinical trials as a treatment for diabetes and dyslipidemia. Thus, Didsbury said a key piece of T3D’s approach to altering the course of Alzheimer’s is insulin regulation.

Researchers have been studying a link between insulin dysregulation and Alzheimer’s for almost a decade. T3D sees insulin deficiency as a trigger for the abnormalities that lead to neurodegeneration.

“Clinical symptoms never occur without sugar metabolism decreases in the brain, which results from neurons becoming resistant to insulin,” he said. “Without the ability to use insulin to access sugar as an energy source, neurons die. T3D-959 acts as a powerful insulin sensitizer.”

Didsbury said the company just closed an oversubscribed seed round this summer, which SEC filings indicate targeted $550,000, and just opened a Series A round. “We will be using those funds to do pre-clinical trials and a pilot clinical trial in Alzheimer’s disease,” he said.

For his part, Didsbury has assembled a supporting cast of science and pharmaceutical business veterans and an advisory board that includes a key developer of Alzheimer’s drug Aricept and the chief of neurology at Duke University Medical Center. The CEO has served in the C-suites of several pharma companies over the last two decades, including NovaTarg and GlaxoSmithKline.

“It has been a personal mission of mine for the last 25 years in the pharmaceutical industry to identify and develop a breakthrough medicine,” Didsbury said. “This is the culmination of that search.”

[Image credit: Flickr user GreenFlames09]