T3D Therapeutics Begins Enrollment in the PIONEER Phase 2 Clinical Trial of T3D-959 in Patients with Mild to Moderate Alzheimer's Disease

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Feb 11, 2020, 06:00 ET

RESEARCH TRIANGLE PARK, N.C., Feb. 11, 2020 /PRNewswire/ -- 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 screening and enrollment for the PIONEER Phase 2 clinical trial for its product candidate T3D-959. T3D-959 is being evaluated for the treatment of patients with mild to moderate Alzheimer's disease. T3D-959 is a small molecule, orally delivered, brain-penetrating dual nuclear receptor agonist designed to improve glucose and lipid metabolism dysfunctions present in AD and other neurodegenerative disorders.

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 expand our testing of T3D-959 in Alzheimer's patients in this new Phase 2 study. It uniquely targets inherent dysfunctional brain metabolism which we believe underlies the formation of plaques, tangles and inflammation in this disease".

"We are encouraged by the recent data from our exploratory, feasibility Phase 2a trial of T3D-959, in which T3D-959 was well-tolerated and evidenced multiple signals of potential efficacy, setting a foundation for the PIONEER study," said John Didsbury, Ph.D., Chief Executive Officer of T3D.

The Phase 2 PIONEER trial will assess the longitudinal safety, tolerability, clinical efficacy and pharmacodynamics of T3D-959, as well as its effects on biomarkers of neurodegeneration. The study will enroll Alzheimer's patients with mild to moderate disease severity.

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) has commenced patient enrollment. PIONEER 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 16-26). PIONEER is designed to assess the safety, tolerability, pharmacodynamics and the effect on clinical outcome assessments. 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.clinical trials.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.

About T3D Therapeutics, Inc.

T3D Therapeutics, Inc. is a privately held, Research Triangle Park, NC-based company. T3D has an exclusive license to T3D-959, its lead product candidate, and a platform of structurally related molecules. T3D's mission is to develop and commercialize T3D-959 for the treatment of Alzheimer's disease and Mild Cognitive Impairment.

For more information visit http://www.t3dtherapeutics.com/.

Contact:

John Didsbury, Ph.D., CEO
T3D Therapeutics, Inc.
1-919-237-4897
Email: info (at) t3dtherapeutics (dot) com

SOURCE T3d Therapeutics, Inc.