vTv Therapeutics Announces Positive Topline Results from Phase 2 Study of TTP273 in Type 2 Diabetes
December 14 2016 - 4:30PM
Business Wire
Oral small molecule GLP-1 receptor agonist met
primary endpoint
Company’s second successful Phase 2 diabetes
trial in 2016
vTv Therapeutics Inc. (vTv) (Nasdaq: VTVT) today announced
positive data from its Phase 2 study evaluating TTP273, an oral
small molecule GLP-1 receptor (GLP-1R) agonist, for the treatment
of Type 2 diabetes. TTP273 demonstrated a statistically significant
reduction in HbA1c. The compound was well-tolerated, with
negligible incidences of nausea and vomiting across all arms of the
study. Trends towards weight loss were also observed.
“It is remarkable to see an oral small molecule therapy that
demonstrates similar benefits of the injectable diabetes GLP1 drugs
without the commonly associated side effects of nausea and
vomiting,” said David D’Alessio, M.D., Professor, Department of
Medicine and Director, Division of Endocrinology, Metabolism, and
Nutrition, Duke University, and vTv Therapeutics Scientific
Advisory Board member. “The convenience of an oral and
well-tolerated GLP-1R therapy has the potential to meaningfully
expand the treatment options for patients with Type 2
diabetes.”
In the 12-week study conducted in 30 centers in the United
States, 174 patients with Type 2 diabetes on stable doses of
metformin were randomized to receive either placebo or TTP273 at
doses of 150 mg once or twice daily. Patients in the once and twice
daily treatment arms had mean placebo-subtracted HbA1c differences
of -0.86 percent and -0.71 percent, respectively. HbA1c increased
by 0.15 percent in patients randomized to placebo. Although the
study was not powered to demonstrate weight loss, trends were
observed with patients losing on average 0.9 kg and 0.6 kg in the
once and twice daily arms, respectively. Analyses of full study
results will continue.
“TTP273 is the first and only oral small molecule GLP-1R agonist
in clinical development. These positive data further validate our
novel approach to drug discovery,” said Steve Holcombe, President
and CEO of vTv Therapeutics. “Based on these results, vTv will
continue to advance development of TTP273 and enter into
discussions with potential partners to bring forward this important
potential new therapy for patients with Type 2 diabetes.”
About TTP273
TTP273 is an oral small molecule that works by activating the
GLP-1 receptor. Activation of the GLP-1 receptor leads to the
enhancement of insulin secretion and suppression of glucagon
production and decreased food intake.
There are currently several marketed injectable GLP-1 therapies.
These agents have demonstrated notable glucose lowering in addition
to weight loss; however, their widespread use may be hindered by
the route of administration (injection) and by the high incidence
of gastrointestinal side effects (nausea and vomiting).
About Type 2 Diabetes
Type 2 diabetes is a result of the body’s inability to use
insulin properly to control sugar in the bloodstream. Type 2
diabetes represents up to 95% of diabetes patients, imposing a
growing burden on healthcare systems globally. Diabetes remains the
7th leading cause of death in the United States, costing the
healthcare system $245 billion annually. According to the American
Diabetes Association, there are 29.1 million Americans, or 9.3% of
the population, living with diabetes.
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 Type 2
diabetes, as well as treatment of inflammatory disorders and the
prevention of muscle weakness.
vTv is also pursuing the clinical development of
TTP399, a novel liver selective Glucokinase Activator (GKA) with
first-in-class potential for the treatment of Type 2 diabetes. vTv
recently announced positive top line results from the six-month
Phase 2b AGATA Study in subjects with Type 2 diabetes.
The company's Alzheimer’s disease drug
candidate, azeliragon, is a novel oral small molecule
antagonist of the Receptor for Advance Glycation Endproducts (RAGE)
with first-in-class potential. The azeliragon development
program has been granted Fast Track Designation and agreement on
its Phase 3 protocol has been reached with FDA via a
Special Protocol Assessment (SPA). Enrollment of part A of the
Phase 3 STEADFAST study in patients with mild Alzheimer's disease
was completed during the third quarter, and topline data from this
part of the study is anticipated to be reported in early 2018.
Forward-Looking Statements
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646-378-2938IR@vtvtherapeutics.comorMedia:Pure
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