TransPharma announces positive results of ViaDerm-hPTH Phase 1 trial for osteoporosis treatment

Oct 26 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 successful results of a 4 week Phase 1 trial of its new self-applied ViaDerm-hPTH(1-34) for the treatment of osteoporosis.

“We are very pleased with the results of this study, in which we successfully demonstrated the performance of our new self-applied ViaDerm system as a product intended for home use”

This study, sponsored by Eli Lilly and Company in collaboration with TransPharma Medical, was a subject and investigator, blind placebo-controlled, dose escalation study of 60 healthy postmenopausal Japanese women, designed to evaluate the safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of hPTH(1-34) (known as Forteo in its injected form). hPTH(1-34) was either administered at the investigational site or self-administered at home for a total of 28 days in transdermal doses of 30, 50, and 80 μg via the ViaDerm system as compared to daily 20 μg Forteo injections.

The results of the study demonstrate ViaDerm-hPTH(1-34) to be safe and well-tolerated with PK and PD (bone biomarkers) dose responses corresponding to the escalating hPTH(1-34) doses of the ViaDerm patches. The PK and PD results related to the postmenopausal Japanese women were consistent with former ViaDerm-hPTH(1-34) Phase 1 and Phase 2a studies conducted in non-Japanese subjects with comparable doses at other locations around the world. TransPharma's new self-applied ViaDerm system has been used successfully by the healthy Japanese postmenopausal women and has performed similarly to that of the Company's previous system, which had to be applied to the patient. This 4-week study was carried out in parallel to a 12-month, multi-site, Phase 2b study currently being conducted in Central and South America and Europe.

"We are very pleased with the results of this study, in which we successfully demonstrated the performance of our new self-applied ViaDerm system as a product intended for home use," said Dr. Daphna Heffetz, CEO of TransPharma Medical. "This is an important step towards introducing the ViaDerm system as a household solution for the self-delivery of a variety of medical substances, first and foremost being hPTH(1-34) for the treatment of osteoporosis."

Source: TransPharma Medical Ltd.