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August 29, 2015 4:01 PM ET

Biotechnology

Company Overview of vTv Therapeutics LLC

Company Overview

vTv Therapeutics LLC, a clinical-stage pharmaceutical company, focuses on the discovery and development of human therapeutics to fill unmet medical needs. It has a pipeline of small molecule clinical and pre-clinical drug candidates for the treatment of a range of human diseases, including central nervous system disorders, diabetes and metabolic disorders, inflammation, and cancer. The company’s core focus is in Alzheimer's disease and Type 2 diabetes. It is also engaged in the discovery of preclinical and clinical drug candidates against multiple molecular target classes, such as kinases, GPCRs, phosphatases, proteases, and protein-protein interactions. vTv Therapeutics LLC was formerly kno...

4170 Mendenhall Oaks Parkway

High Point, NC 27265

United States

Founded in 1998

Phone:

336-841-0300

Fax:

336-841-0310

Key Executives for vTv Therapeutics LLC

Chief Executive Officer, President and President of High Point Pharmaceuticals, Llc
Age: 58
Chief Financial Officer
Age: 57
Chief Scientific Officer and Senior Vice President
Senior Vice President of Chemistry
Senior Vice President of Clinical Development
Compensation as of Fiscal Year 2015.

vTv Therapeutics LLC Key Developments

vTv Therapeutics LLC Appoints Rudy Howard as Chief Financial Officer

vTv Therapeutics LLC announced the appointment of Rudy C. Howard as Chief Financial Officer. Mr. Howard joins the company with over 30 years of senior management experience, most recently serving as CFO at SciQuest. Previously, he served as Senior Vice President and CFO at MDS Pharma Services.

vTv Therapeutics Initiates Patient Dosing in AGATA Study, a six Month Phase 2 Study Evaluating TTP399, a Liver-selective GlucoKinase Activator, for Treatment of Type 2 Diabetes

vTv Therapeutics LLC announced that it has initiated dosing of the AGATA study, a phase 2b clinical trial assessing the efficacy and safety of TTP399, an oral liver-selective Glucokinase Activator (GKA), in patients with type 2 diabetes. In a phase 2a study, TTP399 demonstrated a statistically significant and clinically meaningful reduction in A1c levels compared with placebo after only 6 weeks of dosing, without induction of hypoglycemia or hyperlipidemia and with no induction of insulin secretion in patients with type 2 diabetes. The AGATA (Add Glucokinase Activator to Target A1c) study is a multi-center, double-blind, placebo- and active-controlled (sitagliptin), study to evaluate the safety and efficacy of TTP399 following six months administration in subjects with type 2 diabetes mellitus on a stable dose of metformin. The trial is designed to demonstrate that TTP399 produces significant and sustainable improvement in glycemic control. Patients enrolled will be randomized to receive placebo, 400 mg or 800 mg of TTP399 or 100mg of sitagliptin once daily for 6 months. The primary efficacy endpoint is change in A1c from baseline to the end of randomized treatment. Key secondary endpoints include changes in lipid parameters and body weight. The AGATA study will be conducted in the United States and is expected to enroll approximately 180 patients. vTv Therapeutics, utilizing its proprietary drug discovery platform, TTP Translational Technology®, has discovered and developed a series of novel, small-molecule, liver-selective 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 GK and physiochemical properties that appear to result in functioning only in the liver without interrupting the physiological regulation of GK by the GK 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% 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% at baseline achieved normalization. None of the patients receiving placebo reached A1c normalization.

Calithera Biosciences, Inc. Gains Exclusive, Worldwide License to TransTech Pharma's Hexokinase II Inhibitor Program

Calithera Biosciences Inc. announced an exclusive global license agreement with TransTech Pharma, a clinical stage pharmaceutical company, granting Calithera exclusive world-wide rights to research, develop and commercialize TransTech's portfolio of hexokinase II inhibitors. Hexokinase II is the first and rate-limiting enzyme in the pathway that enables cancer cells to convert glucose to energy and building blocks that feed cancer cell growth. Under the terms of the agreement, Calithera will obtain exclusive, worldwide rights to TransTech's hexokinase II inhibitors for research, development and commercialization. TransTech will receive an upfront payment and will be eligible to receive future development and commercialization milestones as well as royalties on sales of approved products.

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