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Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Osteoporosis
Date:8/5/2009

CAMBRIDGE, Mass., Aug. 5 /PRNewswire/ -- Radius Health ("Radius") today announced topline Phase 2 data demonstrating that in women with osteoporosis, BA058 -- the company's novel PTHrP (parathyroid hormone-related protein) analog -- significantly increased bone mineral density (BMD) at the lumbar spine and femoral neck (a common fracture site located in the hip joint) after six months of therapy. The gains in lumbar spine and femoral neck BMD were further increased in a subset of patients that elected to continue therapy for a total of 12 months of treatment, and at both time points, the changes were greater than those seen with Forteo(R) (teriparatide), the reference drug used in this dose-finding study.

The objective of the 221-patient Phase 2 clinical trial was to assess safety and evaluate the effect of three doses of BA058 on bone formation markers and on lumbar spine and femoral neck BMD over six months relative to placebo. The study also included a Forteo(R) reference arm. Forteo(R), a form of parathyroid hormone, is the only anabolic (bone-building) agent approved for marketing by the U.S. Food and Drug Administration for the treatment of osteoporosis in women and men at high risk of fracture.

BA058 significantly increased mean lumbar spine BMD by 6.7 percent compared with 1.6 percent for placebo and significantly boosted mean femoral neck BMD by 3.1 percent compared with 0.8 percent for placebo at six months for the highest dose tested. By comparison, the mean percent change in the Forteo(R) group for lumbar spine BMD was 5.5 percent, and for femoral neck BMD was 1.1 percent. In the 12-month treatment period, patients receiving the highest dose of BA058 increased lumbar spine BMD by 12.9 percent at 12 months compared with 8.6 percent in the Forteo(R) group and boosted femoral neck BMD by 4.1 percent compared with 2.2 percent for the Forteo(R) group.

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SOURCE Radius
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