- Primary and secondary endpoints were met –
- Study carried out in Japan in parallel to an on-going multi-site Phase 2b study led by Eli Lilly and Company -
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 successful results of a 4 week Phase 1 trial of its new self-applied ViaDerm-hPTH(1-34) for the treatment of osteoporosis.
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."
About the Self Applied 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, virtually no pain, 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.
Osteoporosis is a debilitating disease that affects an estimated 75 million people in Europe, the U.S. and Japan. Osteoporosis, which means “porous bone,” is a disease in which the density and quality of bone are reduced. As the bones become more porous and fragile, the risk of fracture is greatly increased. The loss of bone occurs “silently” and progressively and no symptoms are apparent until the first fracture occurs. The most common fractures associated with osteoporosis occur at the hip, spine and wrist. The incidence of these fractures, particularly at the hip and spine, increases with age in both women and men. Vertebral fractures can result in serious consequences, including loss of height, intense back pain and deformity.
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 which has completed a Phase 1 clinical trial. For more information, please visit the Company's website at www.transpharma-medical.com.
TransPharma Medical Ltd.
KEYWORDS: Asia Pacific Middle East Israel Japan
INDUSTRY KEYWORDS: Health Biotechnology Clinical Trials Pharmaceutical