vTv Therapeutics Announces Publication of Comprehensive Data in Science Translational Medicine Detailing the Discovery & Clin...
January 16 2019 - 1:00PM
Business Wire
Results Found TTP399 Demonstrated a
Statistically Significant Improvement in HbA1c Compared to Placebo
without Hypoglycemia or Hyperlipidemia
vTv Therapeutics Inc. (Nasdaq: VTVT) today announced the
publication of a paper in Science Translational Medicine showcasing
the discovery and development of TTP399, an investigational, oral,
small molecule, liver-selective glucokinase (GK) activator, as a
potential treatment for diabetes. The paper reviews the scientific
rationale underpinning the development of TTP399 and its
progression from preclinical to clinical development concluding
with the positive results of the AGATA study, a phase 2 study of
TTP399 in patients with type 2 diabetes.
In this 6-month study, TTP399 (800 mg/day) was associated with a
statistically significant and sustained reduction in glycated
hemoglobin, with a placebo-subtracted least squares mean HbA1c
change from baseline of −0.9% (p< 0.01). Compared to placebo,
TTP399 (800 mg/day) also increased high-density lipoprotein
cholesterol (3.2 mg/dl; p< 0.05), decreased fasting plasma
glucagon (−20 pg/ml; p< 0.05). Moreover, in patients weighing
≥100 kg, TTP399 decreased weight (−3.4 kg; p< 0.05) compared to
placebo. No hypoglycemia, no detrimental effects on plasma lipids
or liver enzymes, and no increased blood pressure were observed
with TTP399 relative to placebo, highlighting the importance of
tissue selectivity and preservation of physiological regulation
when targeting key metabolic regulators such as GK.
“We are very pleased with the positive results of the AGATA
study. Building on the success seen in type 2 diabetes, we are also
currently conducting an adaptive phase 2 study in collaboration
with the JDRF in subjects with type 1 diabetes and expect to
release results from part 1 of the study later this year. This
paper is a testament to the excellent pre-clinical and clinical
capabilities of our researchers who were able to translate their
deep understanding of GK biology into a promising clinical drug
candidate,” commented Steve Holcombe, president and CEO
of vTv Therapeutics.
“Due to its unique properties, TTP399 has overcome a significant
historical challenge in the development of GK activation,” said Dr.
Adrian Vella, Principle Investigator for the AGATA study and
Professor of Medicine at the Mayo Clinic. “For the first time, a GK
activator has demonstrated sustained meaningful efficacy in a
6-month clinical trial in type 2 diabetes without increasing
hypoglycemia or hyperlipidemia.”
The publication, titled “Targeting Hepatic Glucokinase to Treat
Diabetes with TTP399, a Hepatoselective Glucokinase Activator”, is
published in the latest edition of the peer-reviewed journal
Science Translational Medicine and can be found at
http://stm.sciencemag.org/lookup/doi/10.1126/scitranslmed.aau3441.
GK is a genetically validated target in the development of
diabetes, making it an attractive therapeutic target. However, the
use of GK as a therapeutic target for the treatment of type 2
diabetes has been historically limited by hypoglycemia,
steatohepatitis, and loss of efficacy over time.
The clinical characteristics of patients with GK-activating
mutations or GK regulatory protein (GKRP) loss-of-function
indicated that a hepatoselective GK activator (GKA) that does not
activate GK in beta cells or affect the GK-GKRP interaction may
reduce hyperglycemia in patients with type 2 diabetes, while
limiting hypoglycemia and liver-associated adverse effects.
Using its proprietary drug discovery platform, vTv identified
and characterized small-molecule compounds, including TTP399, with
the ability to increase GK activity in the liver without affecting
the physiological role of GK.
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.
Forward-Looking Statements
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“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
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of new information, future events or otherwise after the date of
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not reflect the potential impact of any future acquisitions,
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these cautionary statements.
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