RESEARCH TRIANGLE PARK, NC / ACCESSWIRE / April 20, 2021 / T3D Therapeutics, Inc. ("T3D"), a clinical stage drug development company engaged in the development of T3D-959, a new orally administered treatment for Alzheimer's disease (AD), announced today the initiation of dosing in a Phase 2 clinical study of neurometabolic regulator T3D-959 in patients with mild to moderate Alzheimer's disease, the PIONEER Study.
T3D-959 is a small molecule, orally-delivered, brain-penetrating PPAR delta/gamma dual nuclear receptor agonist designed to improve both glucose and lipid metabolism dysfunctions present in AD, and other neurodegenerative disorders.
The Phase 2 PIONEER trial has resumed after pausing and making study adaptations in response to the COVID-19 pandemic. The PIONEER trial will assess the longitudinal safety, tolerability, clinical efficacy and pharmacodynamics of T3D-959, as well as its effects on biomarkers of neurodegeneration.
Warren Strittmatter, M.D., Chief Medical Officer of T3D, Emeritus Professor of Neurology at Duke University Medical Center and Alzheimer's Association Zenith Award winner said, "We are excited to resume testing of T3D-959 in the PIONEER Study. T3D-959 acts in a unique way to restore dysfunctional brain metabolism which causes protein misfolding. Plaques, tangles, and even inflammation result from misfolding of proteins in Alzheimer's".
"The PIONEER strategy to target brain metabolism as an Alzheimer's therapy is exciting. Brain metabolism is compromised in Alzheimer's which could be a key driver of multiple pathologies of the disease. Rigorous testing of optimizing brain metabolism in the PIONEER trial is an important advance in discovery and development of cures for AD," said T3D Scientific Advisory Board member Roberta Diaz Brinton, Ph.D.
"This is an important milestone in the development path for T3D-959 as a new potential treatment for those afflicted with Alzheimer's disease," said John Didsbury, Ph.D., Chief Executive Officer of T3D.
About the PIONEER Study
The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) is a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study expected to enroll up to 256 adults with mild-to-moderate Alzheimer's disease (MMSE 14-26). PIONEER is designed to assess the safety, tolerability, and effectiveness of T3D-959 in the treatment of Alzheimer's disease. T3D-959 will be administered orally once daily over a 24-week dosing period. Subjects will receive one of three different doses of T3D-959 or a placebo. To learn more about this study please visit www.clinicaltrials.gov and reference study number NCT04251182.
PIONEER is supported by the National Institute on Aging, part of the National Institutes of Health, under award number R01AG061122 and by the Alzheimer's Association's Part the Cloud Gates Partnership Grant Program.
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. Additionally, T3D Therapeutics is targeting treatments for other neurodegenerative diseases with an emphasis on Huntington's Disease (HD).
For more information visit http://www.t3dtherapeutics.com/.
John Didsbury, Ph.D., CEO
T3D Therapeutics, Inc.
Email: [email protected]
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SOURCE: T3D Therapeutics, Inc.