HIGH POINT, NC, USA I January 21, 2016 I 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 the enrollment of the first patients in the Company’s Phase 2 LOGRA (aLlosteric Oral Glp1 Receptor Agonist) study, a randomized, double-blind, placebo-controlled, parallel group trial of TTP273. TTP273 is an oral, small molecule GLP-1R agonist with best-in-class potential.
The previous Phase 1b trial of TTP273 demonstrated robust effects on postprandial and fasting glucose. All doses of TTP273 were safe and well tolerated with no serious adverse events or evidence of gastrointestinal side effects compared to placebo.
“Earlier studies of this compound showed that TTP273 has the potential to provide enhanced glycemic control and weight loss without the burden of injections or gastrointestinal side effects seen with GLP-1 biologic agents,” said Steve Holcombe, President and CEO of vTv. “TTP273 is just one of two diabetes treatments in our pipeline reading out this year with our best-in-class orally administered Glucokinase Activator, TTP399, expected to report Phase 2 results in mid-2016.”
The LOGRA study is assessing the safety and efficacy of TTP273 in Type 2 diabetic patients on stable doses of metformin. The study’s primary endpoint is change in baseline in HbA1c at 3 months, with secondary endpoints including body weight, plasma glucose, lipids insulin, lactate, C-peptide, glucagon and GLP. The Company anticipates enrolling 156 patients at 26 clinical trial sites throughout the United States. Topline results are expected at the end of 2016.
About vTv Therapeutics Inc.
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.
About Type 2 Diabetes
Type 2 diabetes is the body’s inability to properly use insulin to control sugar in the bloodstream. It is the most common type of diabetes (representing 90 to 95% of diabetes patients), imposing a growing burden on healthcare systems globally. The goal of maintaining HbA1c levels below 7.0% is elusive for patients with this life-long disease. In addition to unregulated glucose, diabetics commonly have a variety of co-morbidities, including heart disease, stroke, high blood pressure, blindness, kidney disease, amputations, dental disease, and central and peripheral nervous system impairment.
About the LOGRA Study
The LOGRA Phase 2 study will evaluate TTP273, which would be an orally bioavailable, potent, non-peptide agonist of GLP-1R for the treatment of type 2 diabetes. This molecule is the second generation from a path-finder molecule TTP054, and it is anticipated to provide enhanced glycemic control, weight loss and an attractive safety profile for the treatment of Type 2 diabetes. The completed Phase 1b trial in TTP273 demonstrated robust effects on postprandial & fasting glucose.
The LOGRA study is expected to read out in late-2016.
SOURCE: vTv Therapeutics
