vTv Therapeutics Announces Topline Results from the First STEADFAST Phase 3 Study Evaluating Azeliragon in People with Mild A...
April 09 2018 - 4:46PM
Business Wire
vTv Therapeutics, Inc. (vTv) (Nasdaq:VTVT) today announced
that results from Part A of the Company’s Phase 3 STEADFAST study
of the investigational medication azeliragon in people with mild
Alzheimer’s disease did not meet either co-primary efficacy
endpoint. Patients taking azeliragon compared with placebo did not
improve in cognitive or functional outcomes as measured by the
Alzheimer's Disease Assessment Scale-cognitive subscale (ADAS-cog)
and the Clinical Dementia Rating Scale Sum of Boxes (CDR-sb).
The STEADFAST study is comprised of two independent and
identical randomized, double-blind, placebo-controlled Phase 3
trials (Part A and Part B). The azeliragon treated group in Part A
had a 4.4 point decline from baseline in ADAS-Cog and a 1.6 point
decline from baseline in CDR-sb compared to a placebo decline of
3.3 and 1.6 respectively. These differences were not statistically
significant. Azeliragon was generally well-tolerated with a 25%
withdrawal rate over 18 months that was similar in both the placebo
and treatment arms.
vTv Therapeutics is discontinuing current clinical studies
involving azeliragon, including the open-label extension study and
Part B of the STEADFAST study. Given the progress to date of
STEADFAST Part B, the company expects that a substantial portion of
the patients in Part B of STEADFAST will have completed 12 months
of treatment under the study protocol. vTv Therapeutics will
continue to thoroughly evaluate subset data from Part A and then
the dataset from Part B over the coming weeks.
“We will continue to analyze the datasets and trends within
subgroups from both Part A and Part B to determine if there are
potential benefits or future uses and applications for azeliragon,”
said Steve Holcombe, chief executive officer, vTv Therapeutics. “On
behalf of vTv Therapeutics, we’d like to extend our most sincere
and heartfelt gratitude to study participants, their families,
physicians and caregivers for their commitment to this important
study.”
About Azeliragon
vTv Therapeutics 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 may contribute to the
pathogenesis of Alzheimer’s disease. Azeliragon, also known as
TTP488, is conceived as a novel orally active small-molecule
antagonist of RAGE.
About STEADFAST
The STEADFAST study, two independent and identical randomized,
double-blind, placebo-controlled Phase 3 trials (Part A and Part
B), was designed to investigate the safety and efficacy of
azeliragon as a potential treatment for patients with mild
Alzheimer’s disease. The 18-month study targeted enrollment of 800
patients (400 in each trial). The first trial enrolled patients
in the United States and Canada who had a clinical
diagnosis of mild Alzheimer's disease and an MRI consistent with
this diagnosis. Enrollment of the second trial included study sites
in the United Kingdom, Ireland, Australia, New
Zealand and South Africa.
About vTv Therapeutics
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 Therapeutics has a pipeline of clinical
drug candidates for the treatment of Alzheimer’s disease, diabetes,
inflammatory disorders and the prevention of muscle weakness.
Forward-Looking Statements
This release contains forward-looking statements, which involve
risks and uncertainties. These forward-looking statements can be
identified by the use of forward-looking terminology, including the
terms “anticipate,” “believe,” “could,” “estimate,” “expect,”
“intend,” “may,” “plan,” “potential,” “predict,” “project,”
“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 clinical programs, 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
statements. These forward-looking statements represent our
estimates and assumptions only as of the date of this release and,
except as required by law, we undertake no obligation to update or
review publicly any forward-looking statements, whether as a result
of new information, future events or otherwise after the date of
this release. We anticipate that subsequent events and developments
will cause our views to change. Our forward-looking statements do
not reflect the potential impact of any future acquisitions,
merger, dispositions, joint ventures or investments we may
undertake. We qualify all of our forward-looking statements by
these cautionary statements.
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Investors:vTv Therapeutics Inc.Mike Biega,
617-221-9660IR@vtvtherapeutics.comorMedia:W2O pureKatie Engleman,
910-509-3977Kengleman@w2ogroup.com
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