– T3D Therapeutics to Receive $9 Million Multiyear National Institute on Aging Grant for Phase 2 PIONEER Study in Mild-to-Moderate Alzheimer’s Disease Patients
T3D Therapeutics, a clinical stage drug development company engaged in the development of T3D-959 (the “Company”), a new orally administered treatment for Alzheimer’s disease (AD), announced today that it has received a grant expected to total $9 million dollars over four years from the National Institute on Aging (NIA), part of NIH, to help fund a Phase 2 clinical study of T3D-959, a novel, metabolic-focused AD drug treatment.
The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer’s Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) is expected to initiate patient dosing in early 2020. PIONEER is a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study expected to enroll up to 252 adults with mild-to-moderate Alzheimer’s disease (MMSE 16-26). PIONEER will enroll subjects who will receive one of three different doses of T3D-959 or a placebo for 24 weeks.
“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” said Chief Executive Officer John Didsbury, Ph.D. “We are truly honored by the support of the NIA and the confidence that our peers have shown in the science underpinning T3D-959.”
“Given the enormous and growing impact of Alzheimer’s on patients and families, there is an urgent need to develop and rigorously evaluate a larger and more diversified portfolio of promising late clinical stage treatments,” said George Vradenburg, Chairman and Co-Founder of UsAgainstAlzheimer’s. “NIA’s support of Phase 2 studies – including this study from T3D Therapeutics – is to be commended and scaled if we are going to achieve our national goal of effectively treating Alzheimer’s in the near future.”
“NIA/NIH and its peer review system are to be lauded for supporting the logic of this new approach and excellent science of the T3D-959 program” said Robert Ingram, former Chief Executive Officer and Chairman of Glaxo/Wellcome.
Warren Strittmatter, M.D., Chief Medical Officer of T3D Therapeutics, Emeritus Professor of Neurology at Duke University Medical Center and Alzheimer’s Association Zenith Award winner 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. 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.”
PIONEER is supported by the NIA under award number R01AG061122.
About T3D Therapeutics, Inc.
T3D Therapeutics, Inc. is a privately-held, Research Triangle Park, NC-based company. The Company has an exclusive license to T3D-959, its lead product candidate, and a platform of structurally-related molecules. T3D Therapeutics’ mission is to develop and commercialize T3D-959 for the treatment of Alzheimer’s disease and Mild Cognitive Impairment. T3D-959 is a small molecule, orally-delivered, brain-penetrating PPAR delta/gamma dual nuclear receptor agonist designed to improve glucose and lipid metabolism dysfunctions present in AD and other neurodegenerative disorders.