vTv Therapeutics Completes Enrollment of Part B of Pivotal Phase III STEADFAST Trial Evaluating Azeliragon for the Treatment ...
June 01 2017 - 7:00AM
Business Wire
-- Azeliragon is the only RAGE receptor
antagonist in clinical development for Alzheimer’s Disease --
vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT) today announced the
completion of enrollment for vTv’s Phase 3 placebo-controlled
trial, STEADFAST (Single Trial Evaluating Alzheimer’s Disease
Following Addition to Symptomatic Therapy). STEADFAST is evaluating
the efficacy and safety of azeliragon, an oral antagonist of the
Receptor for Advanced Glycation Endproducts (RAGE), for treatment
of mild Alzheimer’s disease.
“To date, vTv is the only company with a clinical stage RAGE
program in Alzheimer’s disease, and completion of enrollment in
this trial marks a significant milestone for the company and an
important step forward for the Alzheimer’s community,” said Steve
Holcombe, president and chief executive officer of vTv
Therapeutics. “The impact of this disease on patients and their
families is devastating. We look forward to sharing results from
both trials in 2018 and, if successful, would bring us closer to
advancing a new therapy capable of slowing the 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 difference in
change from baseline between azeliragon and placebo 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.
STEADFAST, a randomized, double-blind, placebo-controlled Phase
3 trial, is investigating the efficacy of azeliragon as a potential
treatment to slow the decline in cognition and functional
activities for patients with mild Alzheimer’s disease. The 18-month
trial targeted enrollment of 800 patients (400 for each Part A and
B). Part A enrolled patients in the United States and Canada.
Enrollment of Part B included study sites in the United Kingdom,
Ireland, Australia, New Zealand and South Africa. Subjects
completing the STEADFAST trial are also eligible to enroll in a
24-month open-label extension trial. STEADFAST was conducted
following agreement with FDA under the Special Protocol Assessment
(SPA) process and the azeliragon development program has been
granted fast track designation. Enrollment of Part A was completed
in September 2016 with data expected to read out in early 2018 Part
B data is expected to read out 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
This release contains forward-looking statements, which involve
risks and uncertainties. These forward-looking statements can be
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terms “anticipate,” “believe,” “could,” “estimate,” “expect,”
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“should,” “target,” “will,” “would” and, in each case, their
negative or other various or comparable terminology. All statements
other than statements of historical facts contained in this
release, including statements regarding the timing of our clinical
trials, our strategy, future operations, future financial position,
future revenue, projected costs, prospects, plans, objectives of
management and expected market growth are forward-looking
statements. These statements involve known and unknown risks,
uncertainties and other important factors that may cause our actual
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
described under the heading “Risk Factors” in our Annual Report on
Form 10-K and our other filings with the SEC. These
forward-looking statements reflect our views with respect to future
events as of the date of this release and are based on assumptions
and subject to risks and uncertainties. Given these uncertainties,
you should not place undue reliance on these forward-looking
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estimates and assumptions only as of the date of this release and,
except as required by law, we undertake no obligation to update or
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InvestorsvTv Therapeutics Inc.Michael Gibralter,
646-378-2938IR@vtvtherapeutics.comorMediaPure Communications
Inc.Katie Engleman, 910-509-3977Katie@purecommunicationsinc.com
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