T3D Therapeutics Achieves Key Milestone: Announcing Final Patient Enrolled in a Phase 2a Trial of T3D-959 for Treatment of Mild to Moderate Alzheimer’s Disease

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T3D Therapeutics, Inc. has achieved a significant clinical trial milestone in its Phase 2a feasibility study in mild to moderate Alzheimer’s disease patients with T3D-959, an investigational new drug candidate that has the potential to be transformative by slowing, stopping or reversing Alzheimer’s disease.

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...T3D-959 may have the potential to transform Alzheimer’s disease by slowing, stopping or reversing the disease.

T3D Therapeutics, Inc. (“T3D Therapeutics” or the “Company”) announces the achievement of a key clinical milestone in its Phase 2a study of T3D-959 in mild to moderate Alzheimer’s disease patients. Patient enrollment has been completed in this open-label, parallel designed study in which patients were randomized to one of four dosing groups. Successful completion of this study will provide a solid basis for conducting additional Phase 2 safety and efficacy studies.

T3D-959, the Company’s lead product candidate, is an investigational new drug that has the potential to change the paradigm for treating Alzheimer’s disease with an approach targeted at improving neuro-metabolic dysfunction in the brains of afflicted patients. As demonstrated in animal studies completed to date, T3D-959 may have the potential to transform Alzheimer’s disease by slowing, stopping or reversing the disease.

T3D Therapeutics initiated its Phase 2a multi-center clinical trial of T3D-959 with the first patient enrolled late last year. This feasibility study is evaluating T3D-959 in 36 patients with mild to moderate Alzheimer’s disease. Patients in the study receive, on a randomized basis, one of 4 different doses of T3D-959 given orally once-a-day for 14 days.

“Completing patient enrollment in this Phase 2a trial represents a significant milestone and important step in our clinical development plan for T3D-959,” says John Didsbury, CEO of T3D Therapeutics. “Given the lack of disease-modifying therapies for Alzheimer’s patients, there is a critical need for novel treatments that have the potential to alter the course of this disease.”

The Phase 2a study is evaluating multiple endpoints, including: changes in brain energy metabolism and brain neural connectivity using brain scans, changes in cognitive function, and safety and tolerability of the drug. Cognitive testing utilizes two neuro-cognitive scales, the first, the Digit Symbol Substitution Test (DSST), evaluates attention, speed in completing tasks, visual tracking, decision making and transformation of information stored in active memory. The second test, the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11), evaluates memory, attention, reasoning, language and orientation. The Company anticipates reporting initial top-line results from this study in the fourth quarter of 2016.

Santosh Gopalakrishnan, MD, a principal investigator in the trial at New Hope Clinical Research in Charlotte, North Carolina, commented, “Alzheimer’s disease is the challenge of the new millennium, with  a significant void in the present therapies available for cure or containment of the disease. There are no current therapies available that effectively treat the onset of dementia or slow down the behavioral deficits or course of this disease. Since the launch of the T3D-959 study, we have unexpectedly received unsolicited, spontaneous caregiver submissions of feedback, noting significant improvements in some of the trial participants. We are excited about these preliminary results and look forward to furthering our understanding of the safety and efficacy of T3D-959 in patients with mild to moderate Alzheimer’s disease.”

For more information on the “Phase 2a Feasibility Study of T3D-959 in Subjects with Mild to Moderate Alzheimer's Disease” clinical trial, please visit ClinicalTrials.gov and reference Identifier NCT02560753.

About Alzheimer’s Disease

Alzheimer’s disease is the most common form of dementia and the sixth-leading cause of death in the United States. 5.4 million Americans are living with Alzheimer’s disease today, and that number is projected to be 16 million by 2050. The number of people around the world with Alzheimer’s is expected to quadruple in the next 35 years.

Alzheimer’s disease is devastating for the patient and their caregivers as it represents a slow, progressive decrease over time in both memory and other intellectual abilities (i.e., cognitive decline). Because it directly affects the brain’s capacity to function, late-stage symptoms include behavior and mood changes, severe memory loss, and eventually difficulty swallowing, speaking, and walking.

The Alzheimer’s disease market is currently dominated by ‘symptomatic’ therapies that address only one facet of Alzheimer’s disease. These agents generally have modest, but temporary effects on cognitive and functional decline and do not affect the underlying course of the disease.

About T3D-959

T3D-959 is a small molecule, orally-delivered, brain-penetrating PPAR delta/gamma dual nuclear receptor agonist. T3D-959 is designed to act to improve neuro-metabolic dysfunction (the brain’s inability to efficiently create and utilize energy) in Alzheimer’s disease. This aspect of Alzheimer’s disease is now recognized as a potential first step in the disease process that then drives the later pathological changes seen in Alzheimer’s disease patients, e.g., amyloid plaques and tau tangles. Based on the animal studies completed to date, T3D-959 appears to treat both the ‘starvation’ of the brain (insufficient energy) and the multiple after-effects of this first insult, which then causes a ‘strangulation’ of the brain (via amyloid plaques, tau tangles and inflammation).

T3D-959’s profile in pre-clinical studies indicates it regulates a myriad of the genes involved in Alzheimer’s disease and thus could offer a greater potential to slow, stop or reverse disease progression. T3D-959 has successfully completed Phase 1 human clinical trials and demonstrated compelling and unique pre-clinical efficacy in an Alzheimer’s animal model. The drug is now in the process of completing a Phase 2a feasibility study of mild to moderate Alzheimer’s disease patients.

About T3D Therapeutics, Inc.

T3D Therapeutics, Inc. is a privately-held, Research Triangle Park, NC-based company incorporated in 2013. T3D Therapeutics’ mission is to develop and commercialize its lead drug product candidate, T3D-959, for the treatment of Alzheimer’s disease and Mild Cognitive Impairment. The Company also has a platform of structurally-related molecules that can be targeted to other neurodegenerative diseases.

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

Forward-Looking Statements

Statements contained in this release that are not statements of historical fact are forward-looking statements, including those statements relating to the Company's expectations regarding clinical studies and developments, and the future potential of its product candidates, including T3D-959, and other statements that are predictive in nature or that depend upon or refer to future events or conditions. Without limiting the generality of the foregoing, words such as “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” are intended to identify forward-looking statements. Readers are cautioned that certain important risks and uncertainties, and assumptions, which if they do not materialize or prove incorrect, may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements which may be made in this release or which are otherwise made by or on behalf of the Company. Factors which may affect the Company’s results include, but are not limited to, uncertainties and/or unexpected results related to research and development and clinical testing, the timing, costs and uncertainty of obtaining any required regulatory approvals, changes in the regulatory landscape, uncertainties related to obtaining additional capital as needed to meet the Company’s needs on acceptable terms, or at all, the absence of any guarantee of product demand, market acceptance or competitive advantage for any of the Company’s product candidates, if approved, and certain trade, legal, social and economic risks. Any forward-looking statement in this release speaks only as of the date on which it is made, and the Company assumes no obligation to update or revise any such forward-looking statement.

Investor Contact

John Didsbury, Ph.D., CEO
T3D Therapeutics, Inc.

Media Contact

Dawn Van Dam, President
Health Connexions, Inc.

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John Didsbury, Ph.D., CEO
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