T3D’s Alzheimer's Drug Gets $9M More in NIA Backing
T3D Therapeutics, a Research Triangle Park company started with loan help from the North Carolina Biotechnology Center, has received a four-year federal grant expected to total $9 million to help study the company’s promising approach for battling Alzheimer’s disease.
The grant from the National Institute on Aging, part of the National Institutes of Health, is to help fund a Phase 2 clinical trial for its leading candidate, T3D-959, an orally administered daily treatment for Alzheimer's.
The company says it expects to begin testing the drug in patients in early 2020 for the Phase 2 PIONEER study (a loose acronym for Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration).
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. 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."
Didsbury is a former GlaxoSmithKline executive who took his pharmaceutical company experience into the entrepreneurship realm by founding T3D in 2013.
NCBiotech awarded T3D a $50,000 Company Inception Loan in 2013 and a $250,000 Small Business Research Loan in 2014. Then in 2015 the company won a $1.8 million Phase 2 Small Business Innovation Research grant, also from the National Institute on Aging, to further develop 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."
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 has reported.
"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 chairman and CEO of Glaxo/Wellcome.
Warren Strittmatter, M.D., chief medical officer of T3D, an emeritus professor of neurology at Duke University Medical Center and an 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."