Radius Health has randomized the first group of patients in its Phase II study of BA058-TD, a transdermal patch delivering a synthetic form of human parathyroid hormone-related peptide (hPTHrP). The patch uses 3M Drug Delivery Systems' patented Microstructured Transdermal System technology, in which an array of microneedles deliver the drug under the skin in an alternative to a subcutaneous injection.
The trial will include up to 240 healthy postmenopausal women with osteoporosis, and will look at safety and efficacy, including changes in bone mineral density and serum markers of bone metabolism, over 6 months. The results will be compared with placebo and with BA058-C, a subcutaneous formulation of the same drug that is in Phase III trials as a daily injection under the skin for fracture prevention in women with severe postmenopausal osteoporosis.
"In a Phase Ib study, BA058-TD showed that with a short wear-time of 5 minutes, peak drug levels were consistent with subcutaneous injection," said Paul Miller of the University of Colorado Health Sciences Center, and an investigator in the study.
Radius hopes that the patch will improve patient compliance and ease of use, and believes that it could potentially grow the opportunity in treating osteoporosis, which it sees as an underserved market.
In February, Radius Health filed a registration document for a proposed IPO, hoping to raise an ambitious $86 million. The company has a good fundraising record, with at least $198 million to date invested in the company.
- read the press release