Radius Begins Phase II Clinical Trial of BA058 for Osteoporosis
- Category: Proteins and Peptides
- Published on Wednesday, 21 March 2007 02:00
- Hits: 2563
CAMBRIDGE, MA, USA | Mar 20, 2007 | Radius announced today that it has commenced enrollment for a Phase II clinical trial of BA058, the company's analog of hPTHrP (human parathyroid hormone-related protein). BA058 is being developed for the treatment of osteoporosis in postmenopausal women, and the Phase II dose-finding study is designed to further evaluate the ability of BA058 to build new bone in this population.
"There is a need for a next generation of osteoporosis drugs that build new bone more rapidly and are more convenient for patients to use," said C. Richard Lyttle, PhD, President and Chief Executive Officer of Radius. "Preclinical and Phase I clinical results with BA058 support its potential to offer these improvements over currently available anabolic therapies, which could result in greater compliance and, ultimately, greater overall benefit to patients."
"The preclinical and Phase I programs have established BA058's safety and demonstrated its ability to induce bone formation without inducing bone resorption or hypercalcemia," said Louis O'Dea, MD, Chief Medical Officer of Radius. "We are pleased with the clinical profile of BA058 as we bring it forward into Phase II development."
PTHrP (parathyroid hormone-related protein) is a critical cytokine for promoting new bone formation, with a role distinct from PTH (parathyroid hormone), which regulates calcium homeostasis and bone resorption. BA058 is an analog of hPTHrP that is designed to build bone without inducing hypercalcemia or significant resorption. In preclinical testing, BA058 demonstrated the potential to widen the anabolic window for bone therapeutics: i.e., stimulating bone formation with a limited effect on bone resorption. In Phase I studies, BA058 generally was well tolerated and did not induce hypercalcemia in doses up to 80mcg.
About the Phase II Study
The Phase II clinical trial is a multicenter, randomized, placebo- and comparator-controlled, dose-finding study in 225 otherwise healthy postmenopausal women with osteoporosis. The study, which is being conducted in the U.S. and Argentina, will further evaluate the safety of BA058 across a range of doses and will assess the ability of BA058 to induce bone formation without induction of resorption through measurement of bone formation and resorption markers and by measuring bone mineral density using a number of different modalities.
Osteoporosis is a leading cause of morbidity and mortality in elderly people worldwide. In the U.S. alone, more than 44 million men and women have osteoporosis or low bone-mineral density. A 50-year-old woman in the U.S. has a 40 percent lifetime risk of osteoporotic fracture. Twenty percent of hip- fracture patients enter long-term care, and half of this group never returns to living independently.
About Radius (http://www.radiuspharm.com)
Radius is a product-driven pharmaceutical company that is a leader in the discovery and development of a new generation of drug therapies for osteoporosis and women's health. Based in Cambridge, Massachusetts, the company was formed in November 2003 and is privately held.