US-based T3D Therapeutics has announced it has received a $9m grant over four years from the US National Institutes of Health (NIH)’s National Institute of Aging to support its Phase II clinical trial of its lead candidate T3D-959 in Alzheimer’s disease.

T3D has a novel mechanism of action focusing on metabolism. It is a peroxisome proliferator-activated receptors (PPAR) delta/gamma dual nuclear receptor agonist that aims to reverse dysfunctional glucose and lipid metabolism in the brain. These targets are highly expressed in the human central nervous system.

The company expected to initiate the Phase II PIONEER study in early 2020. It will be a double-blind, placebo-controlled trial of 252 patients with mild-to-moderate Alzheimer’s disease and it will test three doses of T3D-959.

T3D 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 is a testament to the potential for T3D-959 to treat AD, a disease that we view as a chronic anorexia of the brain.

“We are truly honoured by the support of the NIA and the confidence that our peers

The company’s chief medicaloOfficer and Duke University Medical Center Emeritus professor of neurology Warren Strittmatter said: “This award provides great support for our promising new therapy to give them renewed optimism.

“AD is being increasingly recognized 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.”

T3D-959 is also being investigated in the preclinical phase for Huntington’s disease and nonalcoholic steatohepatitis (NASH). The company claims PPAR delta is known to be central to Huntington’s pathogenesis and insulin resistance is common in NASH patients.

The two other products in T3D’s pre-clinical stage pipeline are also focusing on Alzheimer’s, in addition to vascular dementia and NASH.