vTv Therapeutics Initiates Phase 1b/2 Study Evaluating TTP399 for the Treatment of Type 1 Diabetes
November 08 2017 - 4:35PM
Business Wire
As Part of Industry Partnership with JDRF
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 to
placebo.
“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.
About JDRF
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.
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Investors:vTv Therapeutics Inc.Mike Biega,
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