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

NEW ORLEANS--()--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.

“These results add to the body of preclinical and clinical evidence that support the potential of TTP399 for the treatment of diabetes”

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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vTv Therapeutics Inc.