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Radius Health Presents Positive Phase 3 Top-Line Data for Investigational Osteoporosis Therapy Abaloparatide at the American Society for Bone and Mineral Research 2015 Annual Meeting

WALTHAM, Mass., Oct. 10, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (RDUS) announces positive top-line data from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial, which showed that women with postmenopausal osteoporosis (PMO) who received 18 months of daily abaloparatide (ABL) subcutaneous (SC) injection experienced a 70 percent reduction in the incidence of major osteoporotic fractures compared to placebo. Responder analysis showed greater increases in bone mineral density (BMD) at three combined anatomical sites (total hip, femoral neck and lumbar spine) compared to placebo or teriparatide (TPTD) at 6, 12 and 18 months. These results, along with positive pharmacokinetic data from a study evaluating the ABL transdermal patch, were presented during the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting as oral and poster presentations, respectively.

"The Phase 3 ACTIVE trial found that women who were taking abaloparatide experienced an early risk reduction for major osteoporotic fractures,” said Dr. Lorraine Fitzpatrick, Chief Medical Officer at Radius Health. “These data could be important to patients who have increased skeletal fragility and greater risk of additional fractures.”

ACTIVE is a randomized, double-blind, placebo controlled Phase 3 trial evaluating fracture prevention in more than 2,400 women suffering from PMO.

Abstract #1053: Effects of Abaloparatide on Major Osteoporotic Fracture Incidence in Postmenopausal Women with Osteoporosis

  • PMO women were randomized to receive 18 months of either daily ABL 80-mcg SC, matching placebo SC, or open label TPTD 20-mcg SC. In addition to other endpoints, the study evaluated major osteoporotic fractures, defined as clinical fractures of the forearm, hip, shoulder and clinical spine.
  • Compared with placebo-treated subjects, ABL-SC-treated subjects had a 70 percent reduction in major osteoporotic fractures (HR=0.30, 95% CI: 0.15, 0.61; p=0.0004), which was also 55 percent lower compared to TPTD (HR=0.45, 95% CI: 0.21, 0.95; p=0.031). Compared to placebo, TPTD treated subjects did not achieve a statistically significant reduction in clinical, non-vertebral or major osteoporotic fractures.
  • Data analysis shows early risk reduction with ABL-SC for major osteoporotic fractures. This is a significant finding because women who already had a fracture are at an increased risk for having another fracture.

Abstract #FRO333: Response Rates for Hip, Femoral Neck and Lumbar Spine BMD are Higher for Patients Treated with Abaloparatide when Compared to Placebo or Teriparatide

  • A further analysis of the Phase 3 ACTIVE trial showed greater response rates for BMD at three combined anatomical sites (total hip, femoral neck and lumbar spine) in PMO women treated with ABL-SC for 18 months when compared to placebo or TPTD at 6, 12 and 18 months.
  • A patient was considered to be a responder if she had BMD gains greater than 3 percent at the total hip, femoral neck and lumbar spine.
  • At month 6, 19.1 percent of ABL-SC-treated patients had BMD increases of >3 percent compared to 0.9 percent for placebo (p<0.0001) and 6.5 percent for TPTD (p<0.0001).
  • At month 12, 33.2 percent of ABL-SC-treated patients had BMD increases of >3 percent compared to 1.5 percent for placebo (p<0.0001) or 19.8 percent for TPTD (p<0.0001).
  • At month 18, 44.5 percent of ABL-SC treated patients had BMD increases of >3 percent compared to 1.9 percent for placebo (p<0.0001) or 32.0 percent for TPTD (p<0.0001).

In both studies, ABL-SC showed a favorable safety profile and had significantly lower incidence of hypercalcemia than TPTD. The most common adverse reactions that led to study discontinuation of ABL-SC included dizziness, heart palpitations and headaches.

"Broken bones due to osteoporosis are increasingly common in postmenopausal women, and they are a severe public health crisis worldwide because they carry significant health burdens,” said Robert E. Ward, President and Chief Executive Officer at Radius Health. “These data show that abaloparatide has the potential to provide...


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