As Part of Industry Partnership with JDRF
HIGH POINT, N.C.--(BUSINESS WIRE)--
vTv Therapeutics Inc. (Nasdaq:VTVT) announced today the initiation of
simplici-T1, an adaptive Phase1b/2 study assessing the pharmacokinetics,
pharmacodynamics, safety, and tolerability of TTP399 in adult patients
with type 1 diabetes (T1D). The study is designed to evaluate whether
TTP399 is well tolerated when administered as an add-on to insulin
therapy and can improve daily glucose profiles and HbA1c in people
living with T1D. Results from the Phase1b part of the study are expected
in early 2018. The study is being conducted with support from JDRF, the
leading global organization funding type 1 diabetes (T1D) research.
"It is very exciting to launch this effort to potentially develop a
completely novel pill therapy for type 1 diabetes," 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 principal investigator for this study. "This
disease is characterized by a huge burden of care on more than one
million Americans affected and with limited treatment options. The UNC
team is very hopeful that better treatments for type 1 diabetes will be
near at hand."
TTP399 is an orally available glucokinase enzyme (GK) activator that is
designed to target GK activation only in the liver for superior glucose
control. In the liver, GK is a key regulator of glucose metabolism, and
its activation has been shown to increase glucose utilization, which in
turn lowers blood glucose. In a six-month Phase 2b clinical trial of
TTP399 in patients with type 2 diabetes, TTP399 demonstrated a
statistically significant reduction in HbA1c levels in all TTP399 dose
groups compared with placebo. TTP399 was also found to be well-tolerated
without increased incidences of hypoglycemia and hyperlipidemia compared
"We've gathered promising data in our clinical studies in type 2
diabetes and are eager to explore the potential of TTP399 as an
insulin-adjunctive therapy in type 1 diabetes," said Carmen Valcarce,
Ph.D., executive vice president, chief scientific officer, vTv
Therapeutics. "We are in a unique position to develop next-generation
therapies with JDRF and the UNC team in our corner, and the simplici-T1
study is a very important stepping stone on the way to reaching our goal
to improve the treatment of type 1 diabetes."
About Type 1 Diabetes
Type 1 diabetes (T1D) is an autoimmune disease in which a person's
pancreas stops producing insulin, a hormone that enables people to get
energy from food. It occurs when the body's immune system attacks and
destroys the insulin-producing cells in the pancreas, called beta cells.
While its causes are not yet entirely understood, scientists believe
that both genetic factors and environmental triggers are involved. Its
onset has nothing to do with diet or lifestyle. There is nothing you can
do to prevent T1D, and—at present—nothing you can do to cure it.
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 diabetes as well as treatment of
inflammatory disorders and the prevention of muscle weakness. Last year,
vTv 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.
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.
JDRF is the leading global organization funding type 1 diabetes (T1D)
research. Our mission is to accelerate life-changing breakthroughs to
cure, prevent and treat T1D and its complications. To accomplish this,
JDRF has invested more than $2 billion in research funding since our
inception. We are an organization built on a grassroots model of people
connecting in their local communities, collaborating regionally for
efficiency and broader fundraising impact, and uniting on a national
stage to pool resources, passion, and energy. We collaborate with
academic institutions, policymakers, and corporate and industry partners
to develop and deliver a pipeline of innovative therapies to people
living with T1D. Our staff and volunteers throughout the United States
and our six international affiliates are dedicated to advocacy,
community engagement and our vision of a world without T1D. For more
information, please visit jdrf.org or follow us on Twitter: @JDRF.
This release contains forward-looking statements, which involve risks
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