Radius' Investigational Bone Anabolic Agent, BA058, Increased Bone Mineral Density (BMD) at Key Fracture Sites in Phase 2 Clinical Trial in Postmenopausal Os...(54-84) and had an average lumbar spine B...),Health

Date:8/5/2009

54-84) and had an average lumbar spine BMD T-score of -2.93. All patients underwent four weeks of pretreatment with standard regional supplementation requirements for osteoporosis of not less than 400 IU per day of Vitamin D and not less than 500 mg per day of calcium, which continued throughout the study. Treatment was randomized to Forteo(R) or one of three doses of BA058 (20, 40, or 80 micrograms), or matching placebo. The study's co-primary endpoints were change from baseline in lumbar spine BMD and changes in anabolic bone markers. BMD is a measurement of mineralized bone tissue used to diagnose osteoporosis and to help determine a patient's fracture risk, as well as response to treatment.

About PTHrP and PTH

In bone metabolism, PTHrP (parathyroid hormone-related protein) and its analogs are critical peptides for promoting new bone formation. Though they act through the same receptor, PTHrP and its analogs play a distinct biological role from the PTH (parathyroid hormone) peptide by activating different signaling responses--PTH regulates calcium homeostasis and bone resorption by acting primarily on target cells in bone and kidney, whereas PTHrP and its analogs regulate cell proliferation and differentiation in developing tissues and appear to play an important role in regulating bone remodeling in adults. While both peptides have demonstrated the ability to increase bone mineral density and bone strength in humans, PTHrP and its analogs do not stimulate adverse bone resorption and hypercalcemia to the same extent as PTH, highlighting differing therapeutic effects of the two peptide types on calcium and bone metabolism.

About BA058

BA058 is Radius' novel analog of hPTHrP (human parathyroid hormone-related protein). In Phase I and II studies, BA058 has demonstrated the potential to widen the anabolic window for bone therapeutics by stimulating bone formation with limited effect on bone resorptio
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