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First Liver-Selective Glucokinase Activator for Type 2 Diabetes Demonstrates Normalized HbA1c and No Hypoglycemia in Clinical Trial
High Point, North Carolina (August 14, 2013)
TransTech Pharma Inc. announced today important clinical trial data for its new diabetes drug. TTP399, a novel, liver-selective glucokinase activator (GKA), demonstrated clinical evidence of normalizing HbA1c without inducing hypoglycemia in type 2 diabetic subjects on stable doses of metformin. TTP399 is the first liver-selective GKA that shows no GKA activation in the pancreas and does not interrupt the binding of glucokinase (GK) with the GK regulatory protein (GKRP).
TTP399 has completed a 6-week, multi-center, phase 2a study in type 2 diabetic subjects on stable doses of metformin. TTP399 treatment led to a reduction in HbA1c of 0.92 (p< 0.001) and 0.53 (p< 0.001) placebo-corrected. In addition, 100% of subjects on drug with a starting HbA1c baseline of 7.5% or less achieved the American Diabetes Association’s goal of reducing HbA1c values to 7% or less, and up to 85% of those subjects reached the target of 6.5% or less set by the American Association of Clinical Endocrinologists (AACE). None of the placebo-treated subjects reached the AACE goal. Normalization of HbA1c was achieved without inducing hypoglycemia and after only 6 weeks of treatment.
“Many patients struggle to control their type 2 diabetes mellitus despite the various available treatments,” said Dr. Adnan Mjalli, President and CEO of TransTech Pharma. “I am thrilled to see the results of this study, which are supportive of the evidence that identifies GK as the ‘gatekeeper’ of glucose homeostasis. These results suggest TTP399 dosing for longer than 6 weeks would result in normalizing HbA1c in subjects irrespective of their starting HbA1c.” TTP399 functions only if plasma glucose is above normal levels. The drug has not demonstrated any effect on plasma glucose if the level is within normal range, which is why TTP399 is viewed to act as a glucose sensor and controller. TTP399 is the first reported liver-selective GKA with a unique 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.
TransTech Pharma, 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, drugs that it calls “Glucose Sensors and Controllers.” TransTech Pharma is investigating these compounds in order to demonstrate that liver-selective GKAs provide significant benefits over currently available anti-diabetic therapies.
TransTech Pharma recently obtained back from Forest Laboratories world-wide development rights to its GKA program, including TTP399.
About Type 2 Diabetes
Type 2 diabetes presents a growing burden on healthcare systems globally, with costs exceeding $370 billion annually. 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 TransTech Pharma
TransTech Pharma is a privately held clinical-stage pharmaceutical company focused on the discovery, development, and commercialization of human therapeutics to fill unmet medical needs. The Company’s high-throughput drug discovery platform, TTP Translational Technology®, translates the functional modulation of human proteins into clinical drug candidates. TransTech Pharma has a pipeline of small-molecule clinical and pre-clinical drug candidates for the treatment of a wide range of human diseases, including central nervous system disorders, diabetes, obesity, cardiovascular disease, inflammation and cancer. For further company information, visit http://www.ttpharma.com.