Radius Launches Trial of Osteoporosis Therapy

Radius announced it has begun enrollment in a Phase II clinical trial of BA058, the company's analog of human parathyroid hormone-related protein. BA058 is being developed for the treatment of osteoporosis in postmenopausal women, and the Phase II dose-finding study is designed to further evaluate the ability of BA058 to build new bone in this population.

Preclinical and Phase I clinical trials of BA058 established the drug's safety and demonstrated its ability to induce bone formation without inducing bone

resorption or hypercalcemia. The results also support the potential for the drug to offer an improvement over currently available anabolic therapies, which could result in greater patient compliance, according to the company.

The Phase II clinical trial is a multicenter, randomized, placebo- and comparator-controlled, dose-finding study in 225 otherwise healthy postmenopausal women with osteoporosis. The study, which is being conducted in the U.S. and Argentina, will further evaluate the safety of BA058 across a range of doses and will assess the ability of BA058 to induce bone formation without induction of resorption through measurement of bone formation and resorption markers and by measuring bone mineral density using a number of different modalities.

Parathyroid hormone-related protein is a critical cytokine for promoting new bone formation, according to the company, with a role distinct from parathyroid hormone, which regulates calcium homeostasis and bone resorption.