DB-959Na

New cognition/function and extensive plasma biomarker results of T3D-959 treatment from the Phase 2 PIONEER trial, in a modified intent-to treat population of mild to moderate Alzheimer's patients will be presented at the upcoming Alzheimer's Association International Conference (AAIC) in Philadelphia, PA from July 28 to August 1. T3D-959 is a novel, orally delivered, once-a-day, small molecule drug candidate, designed to activate two nuclear receptors regulating brain glucose energy and lipid metabolism to improve brain health and function. RESEARCH TRIANGLE PARK, N.C., July 24, 2024 /PRNewswire/ -- T3D Therapeutics, Inc., a clinical stage drug development company engaged in the development of a new orally administered treatment for Alzheimer's disease (AD), today announced that CEO, John Didsbury, will be presenting new Phase 2 results in a modified intent-to-treat population of mild to moderate Alzheimer's patients at AAIC. The poster presentation will take place on Sunday, July 28th in Philadelphia, PA. Presentation Details: Continue Reading A Novel Way to Reduce Alzheimer's Amyloid Plaque Burden, Phase 2 Clinical Trial Results of T3D-959 Presented at AAIC Post this Title: Phase 2 PIONEER Trial of Oral T3D-959 for the Treatment of Patients Diagnosed with Mild-to-Moderate Alzheimer's Disease: New Results in a Modified Intent-to-Treat Population Session: Developing Topics: Drug Development Poster Number: Sunday-798 Abstract Number: 95625 Date/Time: July 28, 2024, 8:00am-4:15pm (ET) Location: Pennsylvania Convention Center, Exhibit Hall (Hall BC) Presenter, John Didsbury states, "AD is a disease that encompasses a plethora of neurodegenerative 'triggers' including beta amyloid plaques, tau neurofibrillary bundles, oxidative stress, neuroinflammation and neurotransmitter deficits. Altered glucose and lipid brain metabolism is at its core. Improving brain metabolism can impact these neurodegenerative triggers, including reducing amyloid plaque burden. Current AD drug development is highly focused on plaque reduction, but recently-marketed therapies are not ideal in terms of safety and delivery. The novel mechanism of action, oral once-a-day administration, and safety profile of T3D-959 offers the potential to address the deficiencies of anti-plaque antibodies." About T3D-959: T3D-959, a small molecule, delivered orally once daily, is a 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. About the Study: The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) was a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study that enrolled 250 adults with mild-to-moderate Alzheimer's disease (MMSE 14-26). PIONEER was designed to assess the safety, tolerability, and effectiveness of T3D-959 in the treatment of Alzheimer's disease. T3D-959 was administered orally once daily over a 24-week dosing period. Subjects received one of three different doses of T3D-959 (15mg, 30mg, or 45mg) or a placebo. To learn more about this study please visit 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. 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. For more information visit . CONTACT: John Didsbury, Ph.D., CEO T3D Therapeutics, Inc. 1-919-237-4897 Email: info (at) t3dtherapeutics (dot) com SOURCE T3D Therapeutics, Inc.

RESEARCH TRIANGLE PARK, N.C., Nov. 3, 2023 /PRNewswire/ -- T3D Therapeutics presented top-line results from its Phase 2 PIONEER study at the 16th international conference on Clinical Trials in Alzheimer's Disease (CTAD). The double-blind study compared 3 doses of T3D-959 versus placebo administered orally once a day for 24 weeks in 250 patients with mild to moderate Alzheimer's Disease (AD). Results suggest the potential of T3D-959 to be disease modifying in mild-to-moderate severity Alzheimer's patients. Biomarker data showed modification of multiple disease pathologies inherent in AD. Clinical evidence of improvement in cognition was shown in a sub-group of patients identified with a new blood biomarker of Alzheimer's disease (AD) pathology, pTau-217/Non-pTau-217 ratio. A high pTau-217 ratio in the blood defined an Alzheimer's disease population responsive to T3D-959 therapy. An excellent safety profile was demonstrated after 24-weeks of once daily oral dosing. Analyses showed: The ITT population (all randomized patients) had significant improvement with T3D-959 treatment vs. placebo: In a biomarker of amyloid plaque burden, plasma Ab42/40 ratio (PrecivityAD™), with 30mg of T3D-959 vs. placebo (p=0.021). In fasting plasma glucose, insulin, HDL and other lipids, indicators of an improved metabolic profile. In a plasma biomarker of neurodegeneration, neurogranin (p=0.013). In multiple plasma metabolomic biomarkers of AD neurodegeneration, inflammation, insulin resistance, mitochondrial dysfunction and oxidative stress. In multiple plasma proteomic biomarkers of AD, amyloid plaque formation, neurodegeneration, inflammation, mitochondrial dysfunction and oxidative stress as measured by LC-MS, The ITT population had an excellent safety profile with no drug -related adverse events related to stroke and no clinical signs of ARIA. 55% of subjects had a pTau-217/Non-pTau-217 ratio ≥0.015 indicating they had AD pathology (high pTau-217 ratio group) and exhibited cognitive decline in the placebo group consistent with AD. The high pTau-217 ratio group dosed with 30mg of T3D-959 (N=30) exhibited: An improvement of 2 points vs. placebo in ADAS-cog11 with an effect size at 24 weeks equivalent to or better than that observed for anti-amyloid plaque antibodies at 76-78 weeks. Stronger improvement in the plasma Ab42/40 ratio than the ITT population. A 30mg q.d. dose was identified as providing optimal safety and efficacy for further investigation in a Phase 2b/3 clinical trial in mild-to-moderate AD patients. John Didsbury, Ph.D., Chief Executive Officer of T3D said "PIONEER positive outcomes achieved the goal to inform the design of a larger and longer Phase 2b/3 trial, with dose selection, a 'responder' population of AD patients and biomarkers to assess. " "The exciting results of this study show potential to modify the course of Alzheimer's disease in a unique way. I look forward to seeing these results confirmed and expanded in a larger and longer Phase 2b/3 clinical trial" said Michael Weiner MD, Professor Emeritus at the University of California, San Francisco, and principal investigator of the Alzheimer's Disease Neuroimaging Initiative (ADNI). "The outcomes of this trial are encouraging and lay a foundation for advancing the further development of this new molecule to treat Alzheimer's disease" said Pierre N. Tariot MD, Director of Banner Alzheimer's Institute. About T3D-959: T3D-959, a small molecule, delivered orally once daily, is a 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. About the Study: The Phase 2 PIONEER study (Prospective therapy to Inhibit and Overcome Alzheimer's Disease Neurodegeneration via Brain EnErgetics and Metabolism Restoration) was a double-blind, placebo-controlled, parallel-group Phase 2 safety and efficacy study that enrolled 250 adults with mild-to-moderate Alzheimer's disease (MMSE 14-26). PIONEER was designed to assess the safety, tolerability, and effectiveness of T3D-959 in the treatment of Alzheimer's disease. T3D-959 was administered orally once daily over a 24-week dosing period. Subjects received one of three different doses of T3D-959 (15mg, 30mg, or 45mg) or a placebo. To learn more about this study please visit 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 . CONTACT: John Didsbury, Ph.D., CEO T3D Therapeutics, Inc. 1-919-237-4897 Email: [email protected]