Radius Completes Enrollment for Phase 3 Study of Bone-Building Osteoporosis Drug
Published: Mar 12, 2013
CAMBRIDGE, MA--(Marketwire - March 12, 2013) -
Radius Health has reached the enrollment target of 2400 subjects in BA058-05-003 (see ClinicalTrials.gov), the pivotal Phase 3 trial for BA058-SC. The final subjects entering the trial have now been randomized. This randomized, double-blind, placebo-controlled trial compares BA058-SC daily injection to placebo for prevention of new vertebral fractures over 18 months of treatment as its primary endpoint. Forteo® is an active comparator arm of this study.
"This is a significant milestone for Radius, as we are treating a high risk osteoporosis patient population in 28 centers across the world," said Radius Health Chief Medical Officer Louis Brenner, MD. "We are grateful for the efforts of our patients, investigators, and research collaborators to bring the pivotal study of BA058-SC to this key point, and we look forward to their continued contributions through the treatment and follow-up phases of the study."
Top-line data from the Phase 2 study of BA058-SC demonstrated a significant increase in 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 in women with osteoporosis. BA058 was generally safe and well tolerated in this study. In addition, the occurrence of hypercalcemia was half that of Forteo® in the highest dose of BA058 tested.
"There is a significant unmet need with a large osteoporosis patient population, and those with severe osteoporosis who are at high risk for fracture have few treatment options," said Claus Christiansen, MD, a Radius Advisor, Chairman of the Board of Nordic Bioscience, founder of the Center for Clinical and Basic Research and author of more than 900 articles and books on osteoporosis. "Our team at Nordic Bioscience is deeply engaged in both the Phase 2 trial of BA058-TD and the pivotal Phase 3 trial of BA058-SC. We are excited to have contributed to the achievement of BA058's research milestones and we are optimistic about the potential for BA058 to provide a novel anabolic treatment option for postmenopausal osteoporosis patients."
In its transdermal patch formulation, BA058-TD is being studied in a randomized, double-blind, placebo controlled Phase 2 study in 250 healthy postmenopausal women with osteoporosis. Radius previously announced completion of enrollment in this study in January 2013. BA058-TD is a short wear-time transdermal patch based on 3M's patented Microstructured Transdermal System technology to administer BA058 without the need for subcutaneous injection. The study is designed to assess changes in bone mineral density (BMD) after six months of treatment. In addition, pharmacokinetic parameters and serum markers of bone metabolism for BA058-TD will be compared to both transdermal placebo and BA058-SC.
About Radius Health
Radius is a biopharmaceutical company focused on developing new therapeutics for the treatment of osteoporosis and other women's health conditions. Radius is committed to the development of advanced therapeutics for the large and underserved osteoporosis market. The Company's lead product candidate, BA058, is in development to reduce the risk of complications associated with osteoporosis, such as fracture. Learn more by visiting the company's website at www.RadiusPharm.com.
Safe Harbor for Forward-Looking Statements
Any statements made in this press release relating to future financial or business performance, conditions, plans, prospects, trends, or strategies and other financial and business matters, including without limitation, the prospects for BA058-SC and BA058-TD, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. In addition, when or if used in this press release, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to Radius or its management, may identify forward-looking statements. Radius cautions that these forward-looking statements are subject to numerous assumptions, risks, and uncertainties, which change over time. Important factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including the failure by Radius to secure and maintain relationships with collaborators; risks relating to clinical trials; risks relating to the commercialization, if any, of Radius' proposed product candidates (such as marketing, regulatory, patent, product liability, supply, competition, and other risks); dependence on the efforts of third parties; dependence on intellectual property; and risks that Radius may lack the financial resources and access to capital to fund our operations. Further information on the factors and risks that could affect Radius' business, financial conditions and results of operations are contained in Radius' filings with the U.S. Securities and Exchange Commission, which are available at www.sec.gov. The forward-looking statements represent Radius' estimate as of the date hereof only, and Radius specifically disclaims any duty or obligation to update forward-looking statements.
Forteo® is marketed by Eli Lilly and Company.