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First Liver-Selective Glucokinase Activator for Type 2 Diabetes Demonstrates Normalized HbA1c and No Hypoglycemia in Clinical Tr
Associated Press
2013-08-14 11:42 PM

HIGH POINT, N.C.--(BUSINESS WIRE)--Aug 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 HbA 1c 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 HbA 1c of 0.92 (p< 0.001) and 0.53 (p< 0.001) placebo-corrected. In addition, 100% of subjects on drug with a starting HbA 1c baseline of 7.5% or less achieved the American Diabetes Association's goal of reducing HbA 1c 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 HbA 1c 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 HbA 1c in subjects irrespective of their starting HbA 1c." 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.

About TTP399

TransTech Pharma, utilizing its proprietary drug discovery platform TTP Translational TechnologyR, 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 HbA 1c 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 TechnologyR, 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.

CONTACT: TransTech Pharma, Inc.

Adnan M.M. Mjalli, Ph.D., 336-841-7770

amjalli@ttpharma.com

KEYWORD: UNITED STATES NORTH AMERICA NORTH CAROLINA

INDUSTRY KEYWORD: HEALTH CLINICAL TRIALS DIABETES GENERAL HEALTH

SOURCE: TransTech Pharma, Inc.

Copyright Business Wire 2013

PUB: 08/14/2013 11:14 AM/DISC: 08/14/2013 11:14 AM

http://www.businesswire.com/news/home/20130814005818/en

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