vTv Therapeutics Announces Completion of Phase 1b Study Evaluating TTP399 for the Treatment of Type 1 Diabetes
March 22 2018 - 5:00PM
Business Wire
Simplici-T1 is an adaptive Phase 1b/2 study
being conducted with support from JDRF
vTv Therapeutics Inc. (Nasdaq: VTVT) today announced the
completion of Phase 1b of Simplici-T1, an adaptive Phase 1b/2 study
assessing the pharmacokinetics, pharmacodynamics, safety and
tolerability of TTP399 in adult patients with type 1 diabetes
(T1D). The study, being conducted with support from JDRF, the
leading global organization funding T1D research, is designed to
evaluate TTP399 as an add-on to insulin therapy for people living
with T1D.
The Phase 1b assessment was an open label dose-escalation study
in five patients with T1D, designed to determine the tolerability
of TTP399 when added to insulin and the appropriate dosing range to
be used in Phase 2 of the study. Results showed that TTP399 was
found to be well-tolerated and improved or maintained glycemic
control while reducing or simplifying an insulin regimen. 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.
“There is a tremendous need for new, safe and effective
treatment options for the millions of people living with T1D,” 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. “Maintaining glucose control is
imperative for those with T1D and we are optimistic that treatment
with TTP399 could potentially offer an improved therapy.”
The glucokinase enzyme (GK) is a key regulator of glucose
metabolism, and its activation has been shown to increase glucose
utilization, which in turn lowers blood glucose. TTP399 is an
orally available GK activator that is designed for superior glucose
control by targeting GK activation only in the liver. TTP399
exhibits an insulin-independent mechanism of action which may be
suitable as an adjunctive treatment for T1D.
“We are pleased that TTP399 continues to show favorable
tolerability and hope that further exploration of the therapy in
T1D will produce the same positive effects that were evident in
previous type 2 diabetes clinical studies,” said Carmen Valcarce,
Ph.D., executive vice president, chief scientific officer, vTv
Therapeutics. “With support from JDRF and the UNC team, we are
excited to initiate the Phase 2 portion of the Simplici-T1 study in
April of this year and to further assess the potential of TTP399 as
an insulin-adjunctive therapy for T1D to provide superior glucose
control than insulin monotherapy.”
About Simplici-T1
Simplici-T1 is a multi-center, randomized, double-blind,
adaptive study assessing the pharmacokinetics, pharmacodynamics,
safety and tolerability of TTP399 in adult patients with type 1
diabetes (T1D). This study is being conducted in two phases: Phase
1 evaluated the safety of ascending TTP399 dosage regimens each
over one week of daily dosing; Phase 2 will evaluate the safety and
efficacy of a TTP399 dosing regimen over twelve weeks of daily
dosing.
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
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.
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Investors:vTv Therapeutics Inc.Mike Biega,
617-221-9660IR@vtvtherapeutics.comorMedia:W2O pureKatie Engleman,
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