T3D Therapeutics has received a grant to help fund a Phase II clinical study of T3D-959, a metabolic-focused drug treatment for Alzheimer's disease (AD).
The $9m multiyear grant has been provided by the National Institute on Aging (NIA), which is part of the National Institutes of Health (NIH).
Patient dosing for the Phase II Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration (PIONEER) study is expected to be launched early next year.
T3D Therapeutics CEO John Didsbury said: “We see this grant award as recognition that improving inherent metabolic defects in Alzheimer's disease is a vital and largely unexplored therapeutic avenue in need of pursuit.”
The double-blind, placebo-controlled, parallel-group Phase II safety and efficacy is expected to enroll up to 252 adults with mild-to-moderate AD (MMSE 16-26).
The trial will enrol subjects who will receive one of three different doses of the treatment T3D-959 or a placebo for a period of 24 weeks.
T3D Therapeutics chief medical officer Warren Strittmatter said: “During my lengthy tenure treating AD patients I have seen firsthand the frustrations of caregivers and patients at the lack of an effective therapy with the plethora of recent drug development failures causing them to lose hope.
“AD is being increasingly recognised as resulting from abnormal brain metabolism. T3D-959 is targeted toward those metabolic pathways, which appear to ultimately produce amyloid plaques, tau tangles, inflammation and, most importantly, the dementia.”