T3D Therapeutics Chosen as Late-Breaking Addition to Alzheimer’s Association International Conference to Discuss Rapid Onset of Cognitive Improvement with T3D-959

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On Wednesday, July 27th in Toronto, T3D Therapeutics will present Preliminary Results of a 36-patient, two-week Phase 2a Open Label Feasibility Clinical Trial, showing Rapid Onset of Cognitive Improvements in a Subset of Mild and Moderate Alzheimer’s Patients Treated with T3D-959

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The patient response to T3D-959 in this Phase 2a feasibility study, as reported by their caregivers, has anecdotally indicated rapid onset of cognitive improvements.

T3D Therapeutics was chosen as a late-breaking addition to the Alzheimer’s Association International Conference (AAIC) this year in Toronto. On Wednesday, July 27, 2016, T3D Therapeutics will present “Rapid Onset of Cognitive Improvements in a Subset of Mild and Moderate Alzheimer’s Patients Treated with T3D-959: Interim Results of a Phase 2a Open Label Clinical Trial” at the conference.

The AAIC brings together over 5000 international investigators, clinicians and care providers to share the latest study results, theories and discoveries that will help bring the world closer to breakthroughs in dementia science. This year’s conference will be held at the Metro Toronto Convention Centre, with T3D Therapeutics presenting its poster in the Metro Toronto Convention Centre Room: Hall D/E, P4-390 from 1:00pm - 2:00pm on Wednesday, July 27th.

For a full discussion and power point presentation of the preliminary findings, T3D Therapeutics will also be holding a press conference and information session for interested media, scientists, clinicians, biopharmaceutical companies, investors, and other members of the Alzheimer’s community at 6:00pm in the adjoining hotel. Note: Conference registration is NOT required to attend the 6:00pm presentation.

Full Presentation and Discussion:    

Arrival:
5:45pm, Presentation starts at 6:00pm

Date:
Wednesday, July 27th

Location:
Intercontinental Hotel, Haliburton Room
(adjacent to conference facility)
225 Front Street West, Toronto, Ontario

Register Here for Free for Talk

John Didsbury, PhD, CEO of T3D Therapeutics, who will be presenting the findings, stated, “The patient response to T3D-959 in this Phase 2a feasibility study, as reported by their caregivers, has anecdotally indicated rapid onset of cognitive improvements. We are excited to add to these testimonials preliminary findings from ADAS-cog11 and DSST neuro-cognitive tests, and to present preliminary results of this Phase 2a Open Label Clinical Study at the conference. It will be an important opportunity to discuss the findings and answer any questions at the two sessions, for both conference attendees and those in the area who may not be attending the conference.”

Dr. Warren Strittmatter, CSO of T3D Therapeutics and former Chief of Neurology at Duke University Medical Center will also be in attendance. Dr. Strittmatter is internationally recognized for his basic research in Alzheimer's and Huntington’s disease. He was elected to the Association of American Physicians, the American Society for Clinical Investigation, and received the Alzheimer’s Association Zenith Award. He has served on National Institutes of Health Study Sections and Advisory Boards and Alzheimer’s Association Advisory Committees. He was recognized by the Institute for Scientific Information as the “Top 20 Scientists” in Neuroscience and Behavior for the decade 1992-2002. Dr. Strittmatter has published over 100 papers in peer-reviewed academic journals and has been awarded 12 U.S. Patents.

“Our trial site has received consistently positive reports from patients and their caregivers in this Phase 2a clinical trial. I would like to congratulate T3D on this successful study. We eagerly anticipate a longer [and larger] trial,” remarked Marc Agronin, MD, a principal investigator in the Phase 2a trial at Miami Jewish Health Systems in Miami, Florida.

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 currently anticipates reporting initial final results from this study in the first quarter of 2017.

T3D-959 is an investigational new drug candidate that the Company believes has the potential to be transformative by slowing, stopping or reversing Alzheimer’s disease. T3D Therapeutics, Inc. is a clinical stage drug development company targeting Alzheimer’s disease. The Company has recently completed enrollment and dosing in its Phase 2a Open Label Clinical Trial, and also received approval from the U.S. Food and Drug Administration (FDA) for an open-label, 6-month extension study to this 2-week Phase 2a clinical trial of T3D-959. This extension study is limited to patients who have completed the main study Phase 2a protocol, for whom their caregivers requested, and their physician agreed, that their continued treatment would be a beneficial decision.

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.

T3D Therapeutics is pleased to acknowledge that the Phase 2a Extension Study is being supported by a grant from the Small Business Innovation Research (SBIR) program, as part of the Department of Health and Human Services, National Institutes of Health, from the National Institute on Aging Division.

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. It is estimated that 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 the patient’s 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, the Company’s lead product candidate, is a small molecule, orally-delivered, brain-penetrating PPARdelta/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) that is present in Alzheimer’s disease. This aspect of Alzheimer’s disease is now recognized as a potential first step in the progression of the disease that then drives the later pathological changes seen in Alzheimer’s disease patients, e.g., amyloid plaques and tau tangles in the brain. Based on the pre-clinical animal studies completed to date, T3D-959 appears to treat both the ‘starvation’ of the brain (insufficient energy metabolism) and the multiple after-effects of this first insult which result in 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 we believe could offer a greater potential to slow, stop or reverse disease progression. T3D-959 has successfully completed Phase 1 human clinical trials in healthy volunteers and demonstrated compelling and unique pre-clinical efficacy in an Alzheimer’s animal model. The drug candidate 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. 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. The Company believes that due to its mechanism of action, T3D-959 may also have therapeutic benefit in other central nervous system and 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.
1-919-237-4897
Email: info (at) t3dtherapeutics (dot) com

Media Contact

Dawn Van Dam, President
Health Connexions, Inc.
1-416-402-8274
Email: dawn (at) healthconnexions (dot) com

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John Didsbury
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