vTv Therapeutics Presents Positive Results from a Pilot Study of its Glucokinase Activator at American
Diabetes Association 76th Scientific Sessions
Data show TTP399 improves glycemic control and insulin resistance without hypoglycemia
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 that results from an earlier pilot clinical
study of TTP399, its liver-selective glucokinase activator (GKA) product candidate for the treatment of Type 2 diabetes, were
presented at the American Diabetes Association 76th Scientific Sessions.
In a poster presentation titled, “TTP399, a Novel, Liver Selective Glucokinase Activator: Results from a 10 Day Pilot Study in
Patients with Type 2 Diabetes Mellitus (T2DM) Naïve to Drug,” researchers from vTv reviewed results showing that TTP399, currently
being evaluated in the Phase 2b AGATA study, improved glycemic control and insulin resistance in treatment-naïve diabetes patients.
Importantly, TTP399 did not induce hypoglycemia or have detrimental effects on plasma lipids, as seen with previous GKAs that do
not target the liver.
“These results add to the body of preclinical and clinical evidence that support the potential of TTP399 for the treatment of
diabetes,” commented Dr. Carmen Valcarce, SVP and Chief Scientific Officer of vTv Therapeutics. “Dual-acting GK activators
developed by others caused high rates of hypoglycemia and hyperlipidemia. We believe TTP399’s liver selectivity and preservation of
the physiological regulation of GK—a unique attribute of our GKA—mitigates these side effects, making this compound potentially
useful early in the disease in prediabetes or to intensify therapy without risk of hypoglycemia. We hope to confirm the efficacy
and safety of this approach and to demonstrate the durability of the effect in our ongoing Phase 2b AGATA study, and expect to
report topline data in mid-2016.”
The study, part of the TTP399 clinical development plan, reported data collected from three doses of TTP399 compared to placebo
in treatment-naïve, mild Type 2 diabetes patients (A1c ≤ 7%) over a 10-day treatment period (16 patients received 50 mg, 200 mg or
400 mg oral doses of TTP399, 6 received placebo). Results showed statistically significant improvements over placebo in insulin and
glucose measures in patients receiving the two higher doses of TTP399, while reporting similar adverse events as those receiving
placebo. No hypoglycemia or detrimental effects on plasma lipids were seen in any of the TTP399-treated patients.
The Company expects to report topline results in mid-2016 from the AGATA study, a 180-patient, Phase 2b randomized, placebo
controlled, six-month duration study of TTP399 in Type 2 diabetes patients.
A copy of the presentation will be made available in the News & Events section of the Company’s website following the presentation.
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.
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