T3D Therapeutics Receives FDA Approval for a 6-Month, Open-Label Extension to its Phase 2a Trial of T3D-959 for Treatment of Mild to Moderate Alzheimer’s Disease

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T3D Therapeutics has received FDA approval for an open-label, 26-week extension study in mild to moderate Alzheimer’s disease patients extending its Phase 2a feasibility study of 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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We are gratified to be able to offer certain of the patients in our mild to moderate Alzheimer’s disease clinical trial the opportunity to continue on the T3D-959 study medication in this 26-week, open-label extension study.

T3D Therapeutics, Inc., a clinical stage drug development company targeting Alzheimer’s disease, is announcing that the U.S. Food and Drug Administration (FDA) has granted approval for a 26-week, open-label extension to its 2-week Phase 2a clinical trial of T3D-959 in a limited number of subjects who completed the main Phase 2a study for the treatment of mild to moderate Alzheimer’s disease. FDA approval occurred when the 2-week Phase 2a trial was 50% enrolled.

All patients in the extension study have initiated dosing, being orally administered a 15 mg dose of T3D-959 once daily for 26 weeks. This extension study is limited to patients who have completed the main Phase 2a study protocol, and for whom their caregivers requested, and their physician agreed, that their continued treatment would be a beneficial decision.

“The patients enrolled in the main study, and their caregivers, were not offered this extension study as an opportunity; rather, the caregivers directly requested that their family members be afforded the chance to continue on the medication, based on the response they saw to the medication,” remarked Santosh Gopalakrishnan, MD, a principal investigator in the trial at New Hope Clinical Research in Charlotte, North Carolina.

In the extension study, patients will be regularly assessed for safety and tolerability to T3D-959, and evaluated for changes in cognitive function using two neuro-cognitive scales.

For the neuro-cognitive scales, the first is the Alzheimer's Disease Assessment Scale - Cognitive Subscale (ADAS-cog11), which evaluates memory, attention, reasoning, language and orientation. The second test, the Digit Symbol Substitution Test (DSST), evaluates attention, speed in completing tasks, visual tracking, decision making and transformation of information stored in active memory.

Patients are also being evaluated for changes in clinical global function using the Clinician’s Interview-Based Impression of Change with caregiver input (CIBIC+). The Company anticipates reporting initial top-line results from this extension study in the first quarter of 2017.

John Didsbury, CEO of T3D Therapeutics, stated, “Mid-way through the main Phase 2a study, T3D Therapeutics received FDA approval to reinitiate dosing to a limited number of patients who had completed the two weeks of dosing in the Phase 2a main study. We are pleased that the FDA was able to rapidly review and approve our request within 48 hours. The caregivers who requested this extension study have expressed their gratitude regarding the opportunity to continue this medication.”

The extension study was not part of the original protocol in the two-week Phase 2a trial of T3D-959. This extension has been patient-driven, i.e., the caregivers requested that the patients be allowed to continue receiving T3D-959.

“We are gratified to be able to offer certain of the patients in our mild to moderate Alzheimer’s disease clinical trial the opportunity to continue on the T3D-959 study medication in this 26-week, open-label extension study,” stated T3D Therapeutics’ Advisory Board member Dr. Warren Strittmatter. “The additional 6 months of safety and efficacy data will be valuable to the clinical advancement of this promising drug for Alzheimer’s patients.”

T3D Therapeutics is also pleased to acknowledge that this Extension Study is being supported in part by an Administrative Supplement from the National Institute on Aging of the National Institutes of Health under Award Number R44AG049510. 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 has 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/.

Research reported in this release was supported by the National Institute on Aging of the National Institutes of Health under Award Number R44AG049510. The content of this release is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.

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.
Email: info(at)t3dtherapeutics(dot)com

Media Contact

Dawn Van Dam, President
Health Connexions, Inc.
Email: dawn(at)healthconnexions(dot)com

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John Didsbury, Ph.D., CEO
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