vTv Therapeutics Initiates Phase 2 Clinical Trial Evaluating Azeliragon in Patients with Mild Alzheimer's Disease & Type 2 Di...
June 27 2019 - 4:30PM
Business Wire
vTv Therapeutics Inc. (Nasdaq: VTVT) announced today that the
first patient has been screened for the phase 2 proof of concept
study evaluating the safety and efficacy of azeliragon in patients
with mild Alzheimer's disease and type 2 diabetes.
In a post hoc analysis of the phase 3 STEADFAST trial, a
subgroup of patients with mild Alzheimer’s disease and type 2
diabetes (defined by glycosylated hemoglobin (HbA1c) of greater
than 6.5% at any time during the study) who were treated with
azeliragon demonstrated a potential benefit in both cognition and
function, less brain atrophy and glucose utilization, and decreases
in inflammatory biomarkers compared to the same subgroup of
patients treated with placebo. Additional details can be found on
our publications page.
”We are pleased to announce the initiation of this prospective
phase 2 proof of concept study whereby we seek to confirm our
findings from the post-hoc analyses of the phase 3 STEADFAST
trial,” said Steve Holcombe, President and CEO of vTv Therapeutics.
“With positive results from this study, we would be able to move
quickly into a pivotal phase 3 trial in our pursuit of a treatment
to help the millions of people suffering from mild Alzheimer’s and
type 2 diabetes, two devastating diseases.”
This randomized, double-blind, placebo-controlled, multicenter
trial consists of sequential phase 2 and phase 3 studies
operationally conducted under one protocol. Each part of the study
will evaluate the efficacy and safety of azeliragon in patients
with mild Alzheimer's disease (screening MMSE 21 to 26, baseline
MMSE 19 to 27; and ADAS-cog14 score ≥10) and type 2 diabetes
(screening HbA1c 6.5% to 9.5%, inclusive).
The six-month phase 2 study is designed to enroll approximately
100 patients randomized to either azeliragon 5 mg/day or placebo
with the primary endpoint of change from baseline at month 6 in
ADAS-cog14. The 18-month phase 3 study, to be initiated following
top line results from the phase 2 study, is currently designed to
enroll approximately 200 patients with co-primary endpoints of
change from baseline at month 18 in cognition and function, subject
to modification based upon the phase 2 results. More on the study
can be found on www.clinicaltrials.gov under the identifier
NCT03980730.
vTv expects to report topline results from the phase 2 proof of
concept study by the end of the fourth quarter of 2020.
About Azeliragon
Azeliragon, also known as TTP488, is an orally active
small-molecule antagonist of the receptor for advanced glycation
endproducts, RAGE. 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 ligand
interactions lead to sustained inflammatory states that play a role
in chronic diseases such as diabetes, inflammation, and Alzheimer’s
disease.
About vTv Therapeutics
vTv Therapeutics Inc. is a public, 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 diabetes,
Alzheimer’s disease, and inflammatory disorders.
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 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 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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