The National Institute on Aging (NIA) has provided a 4-year grant for a phase 2 study of T3D-959 (T3D Therapeutics, Research Triangle Park, NC), a novel, metabolic-focused treatment for Alzheimer’s disease (AD).
The PIONEER study, which will begin patient dosing in early 2020, is a double-blind placebo-controlled efficacy and safety study that will enroll up to 252 adults with mild-to-moderate AD. Participants in the study will receive 1 of 3 different oral doses of T3D-959 or placebo for 24 weeks.
In a phase 2a study (NCT02560753), 34 participants with mild-to-moderate AD were randomly assigned to take 1 of 4 oral doses of T3D-959 once daily for 14 days. Results suggested the drug was safe at a probable low dose for effictiveness in improving cognition and motor function/coordination.
“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,” said John Didsbury, PhD, president and chief executive officer, T3D Therapeutics. “It 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 honored by the support of the NIA and the confidence that our peers have shown in the science underpinning T3D-959.”
An activator of 2 PPAR nuclear receptors that regulate brain glucose and lipid metabolism, T3D-959. By activating 2 PPAR receptors, T3D-959 may provide potential additive or synergistic effects in regulating dysfunctional brain glucose energy and lipid metabolism in AD.
Yessar Hussain, MD; Krishna Pokala, MD; and Nancy Kuo, MS, MD
Kimberly P. Gannon, MD, PhD
Jonathan R. Brent, MD, PhD; and Senda Ajroud-Driss, MD