TransPharma Announces Successful Completion of Phase 1a Clinical Trial of ViaDerm-GLP1 Agonist Indicated for the Treatment of Type II Diabetes
- Study Endpoints of Pharmacokinetic Profile, Safety and Tolerability Successfully Met -
- Phase 1b Clinical Study in Patients Has Been Initiated -
LOD, Israel | September 14, 2010 | 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 today 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.
GLP1 agonists/analogues are a new class of medications for the treatment of type II diabetes that offer improved glycemic control with no risk of hypoglycemia. The first GLP1 agonist drug, Exenatide (Byetta), was approved in 2005, and has already reached sales of over $670 million. The drug displays biological properties similar to human glucagon like peptide 1 (GLP1), a regulator of glucose metabolism and insulin secretion. Currently, the drug is administered twice daily to type II diabetes patients via injections.
Dr. Daphna Heffetz, CEO of TransPharma Medical, said, "We are very pleased with the results of this study, which demonstrate significant advantages of our ViaDerm-GLP1 agonist over the injectable marketed product. We have clearly demonstrated a preferable extended drug PK profile when the molecule is administered utilizing our ViaDerm system. The extended profile may allow for once daily painless transdermal administration in comparison to the current two daily injections treatment. We are looking forward to the results of the Phase 1b testing."
About ViaDerm Drug Delivery System
TransPharma's ViaDerm drug delivery system incorporates a handheld electronic device, which creates microscopic passageways through the outer layer of the skin allowing for transdermal delivery of a wide variety of drugs from a patch. The system provides a cost-effective, easy-to-use, self-administered solution that enables the safe, reproducible and accurate delivery of a broad range of product candidates, including hydrophilic small molecules peptides and proteins.
About Diabetes Type II
Diabetes type II, also known as adult onset diabetes, is a chronic disease marked by high levels of glucose in the blood. Type II diabetes is the most common form of diabetes, and is characterized by insulin resistance. Long-term complications include increased risk of heart attacks, strokes, amputation, and kidney failure. Diabetes was the seventh leading cause of death in the USA in 2006. In 2008, in the U.S. alone, diabetes affected 24 million people, which amounts to approximately 8% of the population. The worldwide diabetes market in 2008 was estimated at over $25 billion.
About TransPharma Medical
Established in 2000, TransPharma Medical Ltd. is a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing its proprietary active transdermal drug delivery technology. The company aims to develop multiple drug products through strategic partnerships with leading pharmaceutical companies and through independent product development. TransPharma currently has 3 drug products in clinical trials: ViaDerm-hPTH (1-34) product for the treatment of osteoporosis developed in collaboration with Eli Lilly currently in Phase 2b clinical studies; ViaDerm-GLP1 agonist for the treatment of type II diabetes currently in phase 1b testing and the ViaDerm system combined with an undisclosed peptide currently undergoing phase 1b clinical trials. For more information, please visit the Company's website at www.transpharma-medical.com.