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Investigational Drug Abaloparatide Reduces the Incidence of Fractures in Postmenopausal Women With Osteoporosis

Radius Health announces positive Phase 3 data from the ACTIVExtend trial presented at the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting

First six months of top-line data from ACTIVExtend show that treatment with investigational drug abaloparatide-SC followed by alendronate provides important clinical benefit with reductions in new vertebral, non-vertebral and clinical osteoporotic fractures

WALTHAM, Mass., Oct. 12, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (RDUS) announced positive top-line data from the first six months of the ACTIVExtend trial that showed women who were previously treated with 18 months of abaloparatide (ABL) subcutaneous (SC) injection experienced no new vertebral fractures and an increased bone mineral density (BMD) during the first six months of treatment on alendronate (ALN). These data were presented today at a plenary oral session during the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting.

The first six months of the Phase 3 ACTIVExtend trial were conducted in 1,139 subjects enrolled in the ACTIVE trial, who completed 18 months of treatment with either ABL-SC or placebo. Patients in the ACTIVE study were offered up to 24 additional months of treatment with ALN at a dose of 70 mg per week.

“There is a significant need for additional treatment options for women with postmenopausal osteoporosis who are at risk of experiencing a fracture,” said Dr. Felicia Cosman, Lead Investigator of the ACTIVExtend trial, osteoporosis specialist and Medical Director of the Clinical Research Center at Helen Hayes Hospital, Senior Clinical Director of the National Osteoporosis Foundation and Professor of Medicine at Columbia University. “Abaloparatide was designed to have a unique mechanism of action with the goal of stimulating bone formation, increasing bone mineral density, restoring bone microarchitecture and augmenting bone strength. Impressive results on bone density and fracture risk were seen throughout the skeleton after the first six months of the ACTIVExtend trial, when women were given alendronate after 18 months of abaloparatide treatment. This therapeutic sequence could have the potential to help a broad range of osteoporosis patients.”

Over a 25 month period, women in the ABL-SC/ALN treatment group on average achieved a 12.8 percent increase in BMD at the lumbar spine, a 5.5 percent increase in BMD at the total hip and a 4.5 percent increase in BMD at the femoral neck. In this treatment group, 20.4 percent of patients achieved a 6 percent increase or greater in BMD at all three sites (lumbar spine, total hip and femoral neck).

The adverse events reported during the ALN treatment period were consistent with previous clinical experience. The most common adverse events included arthralgia, dyspepsia, upper respiratory infection, urinary tract infection and bone pain.

"These data build on the positive top-line results from the previously presented ACTIVE trial, which supports the potential use of abaloparatide in women with postmenopausal osteoporosis," said Robert E. Ward, President and Chief Executive Officer at Radius Health. "Osteoporosis is often undiagnosed and is a major public health concern worldwide. We are focusing on providing patients with options for managing this undertreated disease, and we look forward to advancing our U.S. and European regulatory submissions for abaloparatide.”

About ACTIVExtend

ACTIVExtend is an extension study evaluating 24 months of standard-of-care osteoporosis management in women who were at risk for experiencing a fracture, following completion of 18 months of ABL-SC or placebo treatment in the Phase 3 ACTIVE trial.

About Osteoporosis
Osteoporosis affects many postmenopausal women since the production of estrogen, a hormone in women that protects bones, decreases sharply when women reach menopause...


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