The Journal of Clinical Endocrinology & Metabolism Publishes Radius Health's Phase II Study Of The Investigational Drug Abaloparatide In Postmenopausal Women With Osteoporosis

Radius Health, Inc.

announced today that results from a multi-center, multi-national, double-blind placebo controlled Phase 2 trial evaluating the effects of the investigational drug abaloparatide on bone mineral density (BMD) were published online for early release on November 13, 2014, ahead of print by the Journal of Clinical Endocrinology & Metabolism (JCEM) [doi:10.1210/jc.2014-3718]. The investigational drug abaloparatide is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP) currently being developed as an anabolic agent for potential use in the treatment of postmenopausal osteoporosis. The Phase 2 study evaluated the effects of three different doses of abaloparatide on bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck in 222 postmenopausal women with osteoporosis against placebo and an active comparator, teriparatide. The main outcome measures were BMD by dual x-ray absorptiometry and biochemical markers of bone turnover. In the Phase 2 study, 24-weeks of abaloparatide was observed to increase BMD in a dose-dependent manner and to a greater extent than placebo at the lumbar spine (p<.001), femoral neck (p=.036), and total hip (p=.007). The BMD changes observed in the very limited population enrolled in the extension study (7-14 subjects per treatment arm) suggest that the BMD increases with abaloparatide remain relatively linear during the first year of treatment. The Company's Phase 3 clinical trial (ACTIVE) evaluating the investigational drug abaloparatide-SC for potential use in the reduction of fractures in postmenopausal osteoporosis has completed last patient, last visit, and the company plans to announce the top-line, 18-month fracture data in late December 2014. President and CEO, Robert Ward, stated, "The encouraging results being published in the current issue of JCEM support the continued development of abaloparatide as an anabolic therapy for potential use in the treatment of postmenopausal osteoporosis. We look forward to announcing the top-line 18-month fracture data from our Phase 3 ACTIVE study in late December 2014." The potential clinical significance, if any, of these data is being evaluated in Radius' ongoing Phase III clinical trial and is subject to regulatory review of the complete data set on this investigational drug.