Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Os...(8 was generally safe and well tolerated ...),Health

Date:8/5/2009

8 was generally safe and well tolerated in this study, with adverse events similar between the BA058 and placebo/Forteo(R) groups. In addition, the occurrence of hypercalcemia was half that of Forteo(R) in the highest dose of BA058 tested. Radius will submit additional detailed results from the Phase 2 study for presentation at an upcoming medical meeting.

"The results of this study affirm BA058's safety and bone-building activity and support its promise as a next-generation anabolic treatment for osteoporosis," said C. Richard Lyttle, PhD, President and CEO of Radius. "We are especially encouraged by BA058's superior efficacy in building new bone rapidly, particularly at the femoral neck, since hip fractures are one of the most serious complications of osteoporosis and an area in which currently available osteoporosis treatments are weak."

"These data are consistent with the clinical hypothesis for BA058--greater gains in BMD at the critical anatomic sites with less resorptive effect and less hypercalcemia compared to PTH and its analogs," said Louis O'Dea, MD, Chief Medical Officer of Radius. "The greater and faster accrual of BMD with BA058 may allow for shorter durations of treatment and a more rapid reduction in fracture risk in the severe osteoporotic postmenopausal population, which would be a significant advance in the treatment of this debilitating disease."

About the Phase 2 Clinical Trial

The Phase 2 randomized, placebo- and comparator-controlled, parallel-group, dose-finding study was conducted in the U.S., Argentina, United Kingdom, and India and was designed to evaluate the safety and efficacy of BA058 in the treatment of otherwise healthy postmenopausal women with osteoporosis. A total of 221 patients were enrolled and treated in the initial six-month period, and 55 patients continued into a subsequent additional six-month treatment period. Patients were on average 65 years old (
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