-- Multi-center, multi-national, double-blind, placebo-controlled trial in which postmenopausal women were randomized to receive 24-weeks of treatment with either daily subcutaneous injections of placebo, the investigational drug abaloparatide 20, 40 or 80-μg, or teriparatide 20-μg. A 24-week extension also was performed in a subset of subjects
-- Compared to placebo, 24 weeks of daily subcutaneous abaloparatide in this Phase II study resulted in statistically significant increases in bone mineral density (BMD) at the lumbar spine, femoral neck, and total hip in a dose-dependent fashion
WALTHAM, Mass., Nov. 24, 2014 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) announced today that results from a multi-center, multi-national, double-blind placebo controlled Phase 2 trial evaluating the effects of the investigational drug abaloparatide on bone mineral density (BMD) were published online for early release on November 13, 2014, ahead of print by the Journal of Clinical Endocrinology & Metabolism (JCEM) [doi:10.1210/jc.2014-3718].
The investigational drug abaloparatide is a synthetic peptide analog of parathyroid hormone-related protein (PTHrP) currently being developed as an anabolic agent for potential use in the treatment of postmenopausal osteoporosis. The Phase 2 study evaluated the effects of three different doses of abaloparatide on bone mineral density (BMD) at the lumbar spine, total hip, and femoral neck in 222 postmenopausal women with osteoporosis against placebo and an active comparator, teriparatide. The main outcome measures were BMD by dual x-ray absorptiometry and biochemical markers of bone turnover.
In the Phase 2 study, 24-weeks of abaloparatide was observed to increase BMD in a dose-dependent manner and to a greater extent than placebo at the lumbar spine (p<.001), femoral neck (p=.036), and total hip (p=.007). The BMD changes observed in the very limited population enrolled in the extension study (7-14 subjects per treatment arm) suggest that the BMD increases with abaloparatide remain relatively linear during the first year of treatment.
The Company's Phase 3 clinical trial (ACTIVE) evaluating the investigational drug abaloparatide-SC for potential use in the reduction of fractures in postmenopausal osteoporosis has completed last patient, last visit, and the company plans to announce the top-line, 18-month fracture data in late December 2014.
President and CEO, Robert Ward, stated, "The encouraging results being published in the current issue of JCEM support the continued development of abaloparatide as an anabolic therapy for potential use in the treatment of postmenopausal osteoporosis. We look forward to announcing the top-line 18-month fracture data from our Phase 3 ACTIVE study in late December 2014."
The potential clinical significance, if any, of these data is being evaluated in Radius' ongoing Phase III clinical trial and is subject to regulatory review of the complete data set on this investigational drug.
Access the online JCEM manuscript: http://press.endocrine.org/doi/pdf/10.1210/jc.2014-3718
About the Investigational Drug Abaloparatide
Radius' investigational drug abaloparatide (BA058) is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone-building hormone that we believe has the potential to increase bone mineral density by stimulating new bone formation. Abaloparatide SC is an investigational drug currently in Phase 3 development for potential use as a daily self-administered injection for the treatment of patients with postmenopausal osteoporosis at high risk of fracture. Topline, 18-month data from an ongoing Phase 3 pivotal trial comparing abaloparatide SC daily injection to placebo and an active comparator for the prevention of new vertebral fractures are expected in late December 2014. Radius also is developing the investigational drug abaloparatide-TD, for potential use as a short wear-time transdermal patch designed to administer abaloparatide without the need for subcutaneous injection, based on 3M's patented Microstructured Transdermal System technology.
About Radius Health
Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases including hormone responsive cancers. Radius' lead development candidate is the investigational drug abaloparatide (BA058) for subcutaneous injection, currently in Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for potential use in osteoporosis and the investigational drug RAD1901 for potential use in hormone driven, or hormone resistant, metastatic breast cancer, including breast cancer brain metastases. www.radiuspharm.com
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding the meaning of the results of our Phase 2 study evaluating the effects of abaloparatide on BMD; expectations regarding abaloparatide, including without limitation, expectations regarding the availability of topline data from our Phase 3 ACTIVE study in late December 2014; and upcoming events and publications.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: we have no product revenues; our need for additional funding, which may not be available; we are not currently profitable and may never become profitable; restrictions imposed on our business by our credit facility, and risks related to default on our obligations under our credit facility; risks related to raising additional capital; our limited operating history; quarterly fluctuation in our financial results; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; risks related to clinical trials, including having most of our products in early stage clinical trials and uncertainty that results will support our product candidate claims; the risk that adverse side effects will be identified during the development of our product candidates; product candidates for which we obtain marketing approval, if any, could be subject to restrictions or withdrawal from the market and we may be subject to penalties; failure to achieve market acceptance of our product candidates; risks related to the use of our limited resources on particular product candidates and not others; delays in enrollment of patients in our clinical trials, which could delay or prevent regulatory approvals; the dependence of our drug development program upon third-parties who are outside our control; the risk that a regulatory or government official will determine that third-parties with a financial interest in the outcome of the Phase 3 study of abaloparatide-SC affected the reliability of the data from the study; our reliance on third parties to formulate and manufacture our product candidates; failure to establish additional collaborations; our lack of experience selling, marketing and distributing products and our lack of internal capability to do so; failure to compete successfully against other drug companies; developments by competitors may render our products or technologies obsolete or non-competitive; risks related to the fact that our drugs may sell for inadequate prices or patients may be unable to obtain adequate reimbursement; effects of product liability lawsuits on commercialization of our products; failure to comply with obligations of our intellectual property licenses; failure to protect our intellectual property or failure to secure necessary intellectual property related to abaloparatide-SC, abaloparatide-TD, RAD-1901 and/or RAD-140; our or our licensors' inability to obtain and maintain patent protection for technology and products; risks related to our compliance with patent application requirements; failure to protect the confidentiality of our trade secrets; risks related to our infringement of third parties' rights; risks related to employees' disclosure of former employers' trade secrets; risks associated with intellectual property litigation, including expending substantial resources and distracting personnel from their normal responsibilities; risks associated with healthcare reform; our failure to comply with healthcare laws and regulations; our exposure to claims associated with the use of hazardous materials and chemicals; inability to successfully manage our growth; risks relating to business combinations and acquisitions; our reliance on key executive officers and advisors; our inability to hire additional qualified personnel; volatility in the price of our common stock; capital appreciation is the only source of gain for our common stock; risks related to increased costs and compliance initiatives associated with operating as a public company; our directors, executive officers and principal stockholders have substantial control over us and could delay or prevent a change in control; future sales of our common stock could depress the price of our common stock; inaccurate or unfavorable information about us could cause the price of our common stock to decline; provisions in our charter documents and Delaware law could discourage takeover attempts; and our ability to use our net operating loss carryforwards and certain other tax attributes may be limited. These and other important factors discussed under the caption "Risk Factors" in our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission, or SEC, on November 10, 2014, and our other reports filed with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management's estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.
CONTACT: Investor Relations Barbara Ryan FTI Consulting Managing Director 212-850-5679 Barbara.Ryan@fticonsulting.com Media Relations Kimberly Ha FTI Consulting Senior Director 212-850-5612 Kimberly.Ha@fticonsulting.comSource:Radius Health