September 14, 2010 - endpoints of pharmacokinetic profile, safety and tolerability successfully met - Phase 1b clinical study in patients has been initiated – TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced the successful completion of a Phase 1a trial of ViaDerm-GLP1 agonist which is being developed for the treatment of diabetes mellitus type II. The Phase 1 study was a three-way cross over study designed to evaluate the pharmacokinetic (PK) profile and assess safety and tolerability of two doses of ViaDerm-GLP1 agonist in healthy volunteers, as compared to a subcutaneous injection of Exenatide (Byetta). Each volunteer received all three treatments with a washout period of one week between treatments.The results of the study demonstrate ViaDerm-GLP1 agonist to be safe and well-tolerated with a preferable extended PK profile compared to an injection of Exenatide (Byetta). Transdermal application of ViaDerm-GLP1 agonist resulted in therapeutic GLP1 blood levels for approximately 13 hours compared to 6 hours of the injected form. In addition, ViaDerm-GLP1 agonist was demonstrated to be biologically active based on changes in glucose levels during the treatment. TransPharma has initiated enrollment of Type II diabetic patients to a phase 1b clinical trial using its dry form, extended release state-of-the-art patch formulation of GLP1 agonist... TransPharma Medical's Press release -
