TransTech Pharma, Inc., announced today that recruitment of patients for its recently initiated, multi-center Phase 2 clinical trial of TTP054 in type 2 diabetics, is exceeding expectations with initial top line results available in early 2013. The 90-day proof of concept study is being conducted in type 2 diabetics not well controlled with approved oral anti-diabetic agents. TTP054 acts as an agonist of the glucagon-like peptide 1 receptor (GLP1r).
"Currently available anti-diabetic agents fall short in controlling diabetes in a large percentage of the affected population. Therefore, the search for novel drugs and mechanisms to address this huge unmet medical need is imperative," said Dr. Adnan Mjalli, Chairman and CEO of TransTech Pharma. "Injectable GLP-1 analogues, have shown impressive efficacy in the treatment of type 2 diabetes but are associated with several side effects, including nausea and gastrointestinal upset. To our knowledge, TTP054 is the first small-molecule, orally available GLP1r agonist in clinical development, providing the convenience and lower cost of oral agents with a potentially superior GI side effect profile." In a prior 28-day study in type 2 diabetics not well controlled on metformin, TTP054 demonstrated an excellent safety profile and a statistically significant reduction in fasting and post-prandial glucose levels over the course of the study. The observed glucose control in this study is predictive of long-term reduction in HbA1c exceeding 1.0%. In this study, TTP054 was well-tolerated with no evidence of nausea and no serious adverse events. Moreover a significant decrease in plasma lipids was also observed.
Dr. Mjalli added, "TransTech Pharma is fully invested in the discovery and development of oral, small-molecule GLP1r agonists." We believe that oral GLP1r agonists will be a new paradigm for the treatment of type 2 diabetes. Our commitment to this new paradigm in diabetes treatment is shown by our recent investigational new drug application filing for TTP273, a second molecule in our GLP1r agonist program, and its successful completion of its first-in-human study where it demonstrated impressive tolerability, pharmacokinetics and pharmacodynamics."