CAMBRIDGE, Mass., April 2, 2008 /PRNewswire/ -- Radius Health ("Radius") announced today the completion of patient enrollment into its Phase II clinical trial of BA058, the company's bone anabolic candidate for treatment of osteoporosis. The Phase II dose-finding study is designed to further evaluate the ability of BA058 to build new bone for the treatment of osteoporosis in postmenopausal women. Radius also announced today the receipt of a second-tranche financing of $28.3 million based on achieving this milestone, for a total second institutional investment of $67.5 million. Six existing venture investors-MPM Capital, The Wellcome Trust, HealthCare Ventures, Oxford Bioscience Partners, BB Biotech Ventures, and Scottish Widows Investment Partnership-participated in the latest closing. Radius will use the funds to support development of the company's four major product candidates.
The randomized, double-blind, placebo- and comparator-controlled Phase II study is evaluating BA058 in 244 otherwise healthy postmenopausal women with osteoporosis at 35 centers in the United States, United Kingdom, Argentina, and India. The trial is designed to evaluate the safety of BA058 across a range of doses as well as its ability to induce bone formation without inducing resorption through measurement of bone formation and resorption markers and by measuring bone mineral density using a number of different modalities. Radius expects to report the results of the Phase II clinical trial by the end of 2008.
"The completion of patient recruitment in this Phase II trial is a very significant achievement for Radius, and we are grateful for the enthusiasm of our investigators, who have worked diligently to exceed our enrollment target for this study," said C. Richard Lyttle, PhD, President and CEO of Radius. "We believe that BA058 represents a next-generation bone anabolic treatment for osteoporosis that promises to build bone more rapidly and to be more convenient for patients to use. We look forward to communicating the results later this year."
PTHrP (parathyroid hormone-related protein) is a critical peptide for promoting new bone formation, with a role distinct from PTH (parathyroid hormone), which regulates calcium homeostasis and bone resorption. BA058 is an analog of hPTHrP that is designed to build bone without inducing hypercalcemia or significant resorption. In preclinical testing, BA058 demonstrated the potential to widen the anabolic window for bone therapeutics: i.e., stimulating bone formation with a limited effect on bone resorption. In Phase I studies, BA058 generally was well tolerated and did not induce hypercalcemia in doses up to 80 mcg.
Osteoporosis is a leading cause of morbidity and mortality in elderly people worldwide. In the U.S. alone, more than 44 million men and women have osteoporosis or low bone-mineral density. A 50-year-old woman in the U.S. has a 40 percent lifetime risk of osteoporotic fracture. Twenty percent of hip- fracture patients enter long-term care, and half of this group never returns to living independently.
About Radius (www.radiuspharm.com)
Radius is a leading company in the discovery and development of a new generation of drug therapies for osteoporosis and women's health. Radius has raised $91.5 million in private equity financing since its establishment in 2003 and is based in Cambridge, Massachusetts.