Oral Glucokinase Activator has potential to address an underlying
cause of Type 2 diabetes
Company expects to report topline results in mid-2016
vTv Therapeutics Inc. (Nasdaq:VTVT), a clinical-stage biopharmaceutical
company engaged in the discovery and development of new orally
administered treatments for Alzheimer’s disease and diabetes, today
announced the completion of patient enrollment in the Company’s AGATA (Add
Glucokinase Activator to Target A1c) study,
a Phase 2b clinical trial assessing the efficacy and safety of TTP399 in
patients with Type 2 diabetes. TTP399 is a novel oral, liver-selective
Glucokinase Activator (GKA) with first-in-class potential.
Data from a previous Phase 2a trial with TTP399 showed the drug
significantly lowered blood glucose with no evidence of hypoglycemia,
increase in lipids or induction of insulin secretion. Within the
high-dose arm of the study, approximately 86% of “well-controlled”
patients (A1C levels < 7.5) were able to achieve pre-diabetic A1c
levels(<6.5%) after only 6 weeks of treatment without any episodes of
hypoglycemia following administration of the oral treatment.
“We are pleased to reach full enrollment of our AGATA study as we
continue to make strong progress advancing our novel drug candidates for
the treatment of Type 2 diabetes, as well as Alzheimer’s,” said
President and CEO Steve Holcombe. “In earlier clinical studies, TTP399
normalized A1c levels—a measure of glucose—after 6 weeks of treatment
without inducing hypoglycemia. Given the large number of patients who
are unable to reach their target A1c levels with currently available
oral anti-diabetic therapies, we believe TTP399 has the potential to be
an important new therapeutic option for sustained glucose control.”
Continued Mr. Holcombe, “TTP399 is the first of two diabetes candidates
in our pipeline reading out this year. Topline results from the AGATA
study will report in the middle of 2016 followed by results from our
Phase 2 LOGRA study with TTP273, our oral, small molecule GLP-1R
candidate, by the end of 2016.”
The AGATA study is a six-month multi-center, double-blind, placebo- and
active-controlled, parallel group trial in 180 patients with Type 2
diabetes mellitus on a stable dose of metformin. The primary efficacy
endpoint is change in A1c from baseline to the end of randomized
treatment. The Company expects to report topline results from this trial
in the middle of 2016.
About TTP399
vTv Therapeutics, utilizing its proprietary drug discovery platform, TTP
Translational Technology®, has discovered and developed a
series of novel, small molecule, liver-selective Glucokinase Activators
(GKAs) that appear to stimulate the body’s ability to regulate glucose
levels without inducing hypoglycemia. TTP399 is the lead clinical
candidate and is an oral liver-selective compound with a novel binding
mode to glucokinase and physiochemical properties that appear to result
in functioning only in the liver without interrupting the physiological
regulation of glucokinase by the glucokinase regulatory protein.
In a 6-week, multi-center, Phase 2a study in Type 2 diabetic subjects on
stable doses of metformin, TTP399 demonstrated a statistically
significant reduction in A1c levels in all TTP399 dose groups compared
with placebo, without induction of hypoglycemia or hyperlipidemia and
with no induction of insulin secretion in patients with Type 2 diabetes.
Within the high-dose arm of TTP399, approximately 86% of patients with
A1c levels <= 7.5% at baseline achieved blood glucose normalization,
defined as A1c <= 6.5%, after six weeks of treatment, while 50% of
patients with A1c levels <= 8.0% at baseline achieved normalization
after six weeks. For all doses combined, approximately 40% of patients
with A1c levels <= 7.5% at baseline achieved blood glucose normalization
while 25% of patients with A1c levels <= 8.0% at baseline achieved
normalization. None of the patients receiving placebo reached A1c
normalization.
About Type 2 Diabetes
Type 2 diabetes is the body’s inability to properly use insulin to
control sugar in the bloodstream. It is the most common type of diabetes
(representing 90 to 95% of diabetes patients), imposing a growing burden
on healthcare systems globally. The goal of maintaining A1c levels below
7.0% is elusive for patients with this life-long disease. In addition to
unregulated glucose, diabetics commonly have a variety of
co-morbidities, including heart disease, stroke, high blood pressure,
blindness, kidney disease, amputations, dental disease, and central and
peripheral nervous system impairment.
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 Type 2 diabetes as well as
treatment of inflammatory disorders and the prevention of muscle
weakness.
Forward-Looking Statements
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