Radius Initiates Phase 2 Study of BA058-Transdermal for the Treatment of Postmenopausal Osteoporosis
CAMBRIDGE, MA -- Radius Health, Inc. ("Radius"), a biopharmaceutical company focused on developing new therapeutics for the treatment of osteoporosis and other women's health conditions, today announced it has randomized its first patients in a Phase 2 study of BA058-transdermal (BA058-TD) in healthy postmenopausal women with osteoporosis. BA058-TD is a short wear-time transdermal patch based on 3M's patented Microstructured Transdermal System technology to administer BA058 as an alternative to subcutaneous injection.
BA058, a novel, synthetic peptide analog of human Parathyroid Hormone related Peptide ("hPTHrP"), is a bone anabolic compound under development as a potential treatment of severe osteoporosis. In addition to this Phase 2 Study of BA058-TD, BA058 is also currently being studied as a daily subcutaneous injection (BA058-SC) in a Phase 3 study for fracture prevention in women with severe postmenopausal osteoporosis.
"The initiation of our Phase 2 trial for BA058-TD is an important milestone for Radius," said Michael Wyzga, President and Chief Executive Officer of Radius. "The short wear-time transdermal delivery, based on 3M's technology, is intended to improve patient compliance and ease of use, and could potentially grow the opportunity in treating osteoporosis -- an underserved market."
Mr. Wyzga continued, "Our Phase 2 data for BA058-Injection (BA058-SC) demonstrates strong clinical evidence of bone-building capability, and with the initiation of this BA058-Transdermal (BA058-TD) trial, we seek to translate these results into a next generation transdermal formulation for the broader market."
The study is a randomized, double-blind, placebo-controlled trial, designed to evaluate the safety and efficacy of BA058-TD in otherwise healthy postmenopausal women with osteoporosis as assessed by changes in bone mineral density (BMD). In addition, serum markers of bone metabolism for BA058-TD will be compared to both transdermal placebo and BA058-SC. The primary endpoint to be assessed is change in BMD over six months of treatment. Approximately 240 subjects are planned to be enrolled in the study in up to 10 trial centers. Additional study details can be found at www.clinicaltrials.gov .
"In a Phase 1b study, BA058-TD showed that with a short wear-time of five minutes, peak drug levels were consistent with subcutaneous injection," said Paul Miller, MD, Distinguished Clinical Professor of Medicine at the University of Colorado Health Sciences Center, Medical Director at the Colorado Center for Bone Research, and an investigator in the study. "We believe osteoporosis is currently underserved, with inadequate treatment options, and we look forward to further studying this potentially innovative treatment. The potential to provide patients with an effective bone-building alternative to a daily subcutaneous injection is an encouraging prospect."
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-SC, is in development to reduce the risk of complications associated with osteoporosis, such as fracture. The Company also has a next-generation transdermal patch, BA058-TD, being developed as a short wear-time delivery vehicle intended to improve patient compliance with convenience and ease of use, as well as a product in development to treat symptoms associated with menopause.
About 3M Drug Delivery Systems
3M Drug Delivery Systems partners with pharmaceutical and biotech companies to develop pharmaceuticals using 3M's inhalation or transdermal drug delivery technology. 3M offers a full range of feasibility, development and manufacturing capabilities combined with regulatory guidance to help bring products to market. In-house resources, including toxicology, regulatory expertise, quality assurance, operations, and marketed product support, are available for each step of the development and commercialization process. This depth of resources is one reason why more than 50 percent of all metered-dose inhalers worldwide and 80 percent of all transdermal systems in the United States utilize 3M drug delivery technology. For more information, please visit www.3M.com/dds or call 1-800-643-8086.
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 development of Radius' products, the size of the osteoporosis market or the prospects for BA-058SC and BA-058TD, 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.
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SOURCE: Radius Health