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.
A Novel Way to Reduce Alzheimer's Amyloid
Plaque Burden, Phase 2 Clinical Trial Results of T3D-959 Presented
at AAIC
Presentation Details:
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 www.clinicaltrials.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
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 http://www.t3dtherapeutics.com/.
CONTACT:
John Didsbury, Ph.D., CEO
T3D Therapeutics, Inc.
1-919-237-4897
Email: info (at) t3dtherapeutics (dot) com
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SOURCE T3D Therapeutics, Inc.