T3D Therapeutics, a young Research Triangle Park company started with loan help from the North Carolina Biotechnology Center, has received approval from the Food and Drug Administration to test its lead drug candidate in patients with Alzheimer’s disease.
“This is a significant milestone for our company,” said CEO John Didsbury.
T3D plans to begin a phase two-a study this summer on the heels of the FDA’s approval of its Investigational New Drug application.
The drug candidate, T3D-959, is a potential therapeutic for Alzheimer’s disease, designed to be given orally once a day. The molecule passed a phase one clinical trial for safety and tolerability in healthy volunteers, and in pre-clinical studies using an Alzheimer’s animal model it showed positive effects on memory, motor function, inflammation, neuronal cell death, beta amyloid production and tau (protein) alteration.
Unlike most Alzheimer’s therapies in development that target one disease pathway, such as beta amyloid plaques or tau bundles, T3D-959 acts on multiple pathologies, including a likely trigger for the disease, insulin resistance in the brain. As a dual nuclear receptor agonist, T3D-959 may regulate many genes involved in Alzheimer’s and could be a powerful insulin sensitizer, anti-inflammatory and neuroprotectant, offering a greater potential to slow, stop or reverse disease progression, the company reports.
The phase two-a clinical study will evaluate T3D-959 in 36 patients with mild-to-moderate Alzheimer’s disease. In addition to evaluating safety, the study will examine changes in cerebral glucose metabolism and neural (brain cell) connectivity.
The company has been selected by the Alzheimer’s Association to present its pre-clinical results of T3D-959 at the upcoming Alzheimer’s Association International Conference in Washington, D.C., July 18 through 23.
T3D Therapeutics is a privately held company established in 2013 to develop therapeutics for the treatment of Alzheimer’s and other central nervous system disorders.
NCBiotech awarded T3D a $50,000 Company Inception Loan in 2013 and a $250,000 Small Business Research Loan in 2014. Earlier this year the company won a $1.8 million phase two Small Business Innovation Research grant from the National Institute on Aging to further develop T3D-959.
(C) NC Biotechnology Center