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.
James Geyer, MD, and Paul Cox
Allie Massaro, MD
Vanessa Baute Penry, MD; Rachana Gandhi Mehta, MD; and Fatemeh Sadeghifar, BS