- Study endpoints of pharmacokinetic profile, safety and tolerability successfully met –
LOD, Israel--(BUSINESS WIRE)-- 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 1b trial of ViaDor-GLP1 agonist, which is being developed for the treatment of diabetes mellitus type II.
The Phase 1b study was a single-dose, four-way cross over study designed to evaluate the pharmacokinetic (PK) profile, safety and tolerability of ViaDor-GLP1 agonist in diabetic patients using TransPharma's extended release state-of-the-art film patch of GLP1 agonist. The study was performed on 14 type II diabetic patients, and evaluated a once daily application of three patch formulations, as compared to a twice daily subcutaneous injection of Exenatide (Byetta).
The results of the study demonstrate ViaDor-GLP1 agonist to be safe and well-tolerated with a preferable extended PK profile compared to Exenatide (Byetta), the injected GLP-1 agonist. Transdermal applications of ViaDor-GLP1 agonist resulted in therapeutic blood levels for approximately 20 hours compared to 6 hours post injection of Exenatide. Concurrently, post postprandial glucose levels were consistent with ViaDor-GLP1 extended PK profiles.
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. Currently, these drugs are administered once or twice daily to type II diabetes patients via subcutaneous injections.
"In this Phase 1b study we have shown that our modified GLP1 agonist film patch results in a significantly extended PK profile with a similarly extended effect on glucose levels in diabetic patients," said Dr. Daphna Heffetz, CEO of TransPharma Medical. "We are also extremely pleased to announce that the extended release film patch used in this study retains the same size and design as our printed patch for immediate drug delivery, and similarly has the potential for long shelf life at room temperature. Our product may thus offer a safe, user-friendly and painless solution for controlling blood glucose levels in people suffering from diabetes mellitus type II."
About ViaDor Drug Delivery System
TransPharma’s ViaDor 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 world wide 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: ViaDor-hPTH (1-34) product for the treatment of osteoporosis developed in collaboration with Eli Lilly currently in Phase 2b clinical studies; ViaDor-GLP1 agonist for the treatment of type II diabetes has completed phase 1b testing and the ViaDor-Calcitonin for the treatment of musculoskeletal disorders completed phase 1 clinical trials. For more information, please visit the Company's website at www.transpharma-medical.com.
TransPharma Medical Ltd.
KEYWORDS: Middle East Israel
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical