vTv Therapeutics Announces Positive Initial Topline Results from Phase 2b Study of Glucokinase Activator TTP399 in Type 2 Dia...
August 10 2016 - 7:00AM
Business Wire
Novel glucokinase activator shows sustained
meaningful reduction in HbA1c with well-tolerated treatment
regimen
vTv Therapeutics Inc. (Nasdaq:VTVT), a clinical-stage
biopharmaceutical company engaged in discovery and development of
new orally administered treatments for Alzheimer’s disease and
diabetes, today announced positive topline results from a placebo
and active-comparator-controlled Phase 2b clinical study of TTP399,
a liver-selective glucokinase activator under development for the
treatment of Type 2 diabetes.
Topline results showed achievement of the primary endpoint of
statistically significant change from baseline in HbA1c at 6 months
of daily administration of 800 mg of TTP399. The reduction in HbA1c
was dose-dependent and sustained throughout the duration of the
study. TTP399 was also found to be well-tolerated. Further analysis
of the data is ongoing.
“We are extremely pleased with these findings from our Phase 2b
study of TTP399,” commented Steve Holcombe, President and CEO of
vTv Therapeutics. “These results show that a glucokinase activator
with hepatic selectivity may lead to a meaningful reduction in
HbA1c on a sustained basis. We are enthusiastic about advancing
TTP399 to the next stage of development.”
“We now have a glucokinase activator that appears to improve
glucose control in a safe and sustained manner. Although further
studies are necessary, I believe the Phase 2 results suggest that
TTP399 may become a significant treatment option in diabetes care,”
said Dr. John Buse, Director of the North Carolina Translational
and Clinical Sciences Institute and of the Diabetes Center at the
University of North Carolina School of Medicine and a member of the
vTv Therapeutics Scientific Advisory Board.
The Phase 2b AGATA (Add Glucokinase
Activator to Target A1c) study was a
six-month, multicenter, randomized, double-blind, placebo- and
active-comparator-controlled, parallel group Phase 2b trial. The
primary endpoint was change from baseline in HbA1c at six months.
190 subjects with Type 2 diabetes were enrolled and randomized into
four arms, and 110 subjects remained in the trial through
completion. 26 subjects received a daily dose of 800 mg of TTP399
for the full six-month course of treatment.
A manuscript with more details is in preparation and will be
submitted for publication to a major medical journal.
About Glucokinase and TTP399
Glucokinase (GK) is a key regulator of glucose homeostasis. GK
is a genetically validated target. Loss of function mutations in
the gene coding for GK can cause hyperglycemia and Type 2
diabetes.
Activation of GK, a mechanism of action that is distinct from
existing Type 2 diabetes treatments, enhances GK activity thereby
improving glycemic control in Type 2 diabetes. Previous attempts to
develop GK activators were unsuccessful due to increased incidence
of hypoglycemia, hyperlipidemia, and lack of sustained clinical
effect.
TTP399 is an orally bioavailable small molecule GK activator.
Unlike previous approaches, TTP399 targets GK activation only in
the liver and does not appear to disrupt the interaction between GK
and glucokinase regulatory protein (GKRP), which may lead to
hypoglycemia, limited durability of response and other side
effects. TTP399 was discovered by vTv scientists using its
proprietary translational technology platform.
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 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.
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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InvestorsThe Trout GroupMichael Gibralter,
646-378-2938mgibralter@troutgroup.comorMediaBMC
CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.com
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