vTv Therapeutics Completes Enrollment of Part A of Pivotal Phase 3 Trial Evaluating Azeliragon for the Treatment of Patients ...
September 07 2016 - 7:00AM
Business Wire
Phase 2b Trial Showed Positive Results In
Slowing Cognitive Decline
vTv Therapeutics Inc. (NASDAQ:VTVT) today announced the
completion of enrollment for Part A of STEADFAST (Single Trial
Evaluating Alzheimer’s Disease Following Addition to Symptomatic
Therapy), vTv’s Phase 3 placebo-controlled trial of azeliragon, an
oral antagonist of the Receptor for Advanced Glycation Endproducts
(RAGE), for treatment of mild Alzheimer’s disease. Phase 3 follows
a Phase 2b trial that demonstrated positive results in slowing
cognitive decline with 5 mg/day of azeliragon in patients with mild
to moderate Alzheimer’s disease.
“With completion of enrollment of patients in Part A of our
Phase 3 trial, we are excited to reach another significant
milestone in the development of azeliragon as a potential therapy
to slow the decline of cognition and function in patients with
Alzheimer’s disease,” said Steve Holcombe, President and CEO of
vTv. “There remains a critical need for the development of new
treatments for this devastating disease. Azeliragon’s novel
mechanism targets a receptor that we believe is involved in
multiple pathologic processes leading to the development and
progression of Alzheimer’s disease.”
The Phase 2b results of 5mg per day of azeliragon over a period
of 18 months showed statistically significant benefit in
mild-to-moderate Alzheimer’s patients (+3.1 points on ADAS-Cog11
standard measure of cognition) and greater benefit in mild patients
(+4.0 points on ADAS-Cog11), with improvements on secondary
endpoints including a statistically significant reduction in
psychiatric adverse events.
vTv is continuing to recruit and enroll new patients for Part B
of the STEADFAST Study. Physicians and researchers looking for more
information about the trial can visit www.livingsteadfast.com
or call 336-841-0300 ext 120.
About the STEADFAST Study
STEADFAST is a randomized, double-blind, placebo-controlled
Phase 3 trial that is investigating the efficacy of azeliragon as a
potential disease modifying therapy for patients with mild
Alzheimer’s disease. The trial targets enrollment of 800 patients
(400 for each Part A and B) in the United States and Canada who
will receive 18 months of treatment. Enrollment of Part B will be
expanded to include study sites in the United Kingdom, Australia,
New Zealand and South Africa. Subjects completing the STEADFAST
trial may be eligible to enroll in a 24-month open-label extension
trial. STEADFAST is being conducted following agreement with FDA
under the Special Protocol Assessment (SPA) process with fast track
status. Data from Part A of the trial is expected to read out in
early 2018 with Part B in late 2018.
About Azeliragon
vTv discovered and developed azeliragon using its proprietary
drug discovery platform TTP Translational Technology®. A broad
range of human pathologic and experimental biologic investigation
suggests that RAGE activation contributes to the pathogenesis of
Alzheimer’s disease. Sustained Amyloid-β interactions with RAGE at
the blood-brain barrier (BBB) and in neuronal and microglial cells,
play potentially major roles in amyloid plaque formation,
neuroinflammation and chronic neural dysfunction – all hallmarks of
Alzheimer’s disease. Azeliragon, also known as TTP488, is a novel
orally active small-molecule antagonist of RAGE.
About vTv Therapeutics Inc.
vTv Therapeutics Inc. is a clinical-stage biopharmaceutical
company engaged in the discovery and development of orally
administered small molecule drug candidates to fill significant
unmet medical needs. vTv has a pipeline of clinical drug candidates
led by programs for the treatment of Alzheimer’s disease and type 2
diabetes as well as treatment of inflammatory disorders and the
prevention of muscle weakness. Last month, vTv announced positive
topline results from a placebo and active-comparator-controlled
Phase 2b clinical study of TTP399, a liver-selective glucokinase
activator (GKA) under development for the treatment of Type 2
diabetes.
The Company’s drug candidates were discovered with its
high-throughput drug discovery platform, TTP Translational
Technology®, which translates the functional modulation of human
proteins into safe and effective medicines. For further company
information, visit www.vtvtherapeutics.com.
Forward-Looking Statements
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risks and uncertainties. These forward-looking statements can be
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negative or other various or comparable terminology. All statements
other than statements of historical facts contained in this
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trials, our strategy, future operations, future financial position,
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results, performance or achievements to be materially different
from any future results, performance or achievements expressed or
implied by the forward-looking statements. Important factors that
could cause our results to vary from expectations include those
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Form 10-K and our other filings with the SEC. These forward-looking
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