The data was presented in an Oral Late-Breaker at Annual Endocrine Society Meeting "ENDO 2017" on April 1
Additional analysis of BMD gains at the wrist and fracture reductions at the ultradistal radius compared to placebo and teriparatide were presented on April 2
WALTHAM, Mass., April 03, 2017 (GLOBE NEWSWIRE) -- Radius Health, Inc. ("Radius" or the "Company") (Nasdaq:RDUS), a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, presented results from new analyses of the Phase 3 ACTIVE clinical trial of abaloparatide-SC, one during a late-breaker oral session at ENDO 2017, in Orlando, Fla., and the other in a late-breaker poster presentation.
Abaloparatide-SC is an investigational treatment for postmenopausal women with osteoporosis and its safety and efficacy have not been established. A New Drug Application for abaloparatide is currently under review by the U.S. Food & Drug Administration and a Marketing Authorisation Application is currently under review by the European Medicines Agency.
In an oral presentation titled: "Comparison of the Geography of Fracture Incidence in Postmenopausal Women with Osteoporosis Treated with Abaloparatide-SC Versus Placebo during the ACTIVE Trial", data from pre-specified exploratory analyses of ACTIVE across geographic subgroups (North America, South America, Europe, Asia), showed that abaloparatide-SC consistently reduced the risk of vertebral, nonvertebral, clinical and major osteoporotic fractures across geographies versus placebo. A separate post hoc analysis from these data also showed that the effects of abaloparatide-SC versus placebo on fracture risk reduction were also similar for women of Hispanic/Latino ethnicity compared to other women enrolled in ACTIVE.
"This sub-analysis showed consistent and significant reductions in fracture risk across all sites in postmenopausal women with osteoporosis who received abaloparatide-SC versus placebo irrespective of geography, including the Hispanic/Latino population." said Michael R. McClung, MD, FACP, FACE, lead study author and founding director of the Oregon Osteoporosis Center in Portland, Ore.
Radius also presented a second late-breaking abstract on April 2, 2017 titled: "Forearm Bone Mineral Density and Fracture Incidence in Postmenopausal Women with Osteoporosis: Results from the Abaloparatide-SC Phase 3 Trial (ACTIVE)" from a separate analysis of ACTIVE with the objective of assessing the effect of abaloparatide-SC on the ultradistal radius, a site relevant to the risk of wrist fractures to evaluate the effects of teriparatide and abaloparatide-SC treatment on this risk. These data showed that BMD increased significantly at the ultradistal radius in the abaloparatide-SC treated group compared with the placebo and teriparatide treated groups, and are consistent with the numerically lower risk of wrist fractures in women treated with abaloparatide-SC compared with teriparatide. The results are also consistent with the reduction shown in nonvertebral fractures, sites rich in cortical bone, with abaloparatide-SC compared with placebo observed during ACTIVE.
"The totality of the data from ACTIVE demonstrate abaloparatide-SC's ability to reduce the risk of nonvertebral fracture in postmenopausal women with osteoporosis, which is extremely important as nonvertebral fractures account for about 90% of the health care costs associated with fractures and can be harder to treat, " said Nelson Watts, MD, Director of Osteoporosis and Bone Health Services Mercy Hospital, Cincinnati.
About Postmenopausal Osteoporosis
Osteoporosis is a silent disease, often displaying no signs or symptoms until a fracture occurs, leaving the majority of patients undiagnosed and untreated, representing a high unmet medical need. Osteoporotic fractures create a significant healthcare burden. An estimated two million osteoporotic fractures occur annually in the United States, and this number is projected to grow to three million by 2025.
The National Osteoporosis Foundation (NOF) has estimated that 10 million people in the U.S., composed of eight million women and two million men, already have osteoporosis, and another approximately 44 million people have low bone mass placing them at increased risk for osteoporosis.
The debilitating effects of osteoporosis have substantial costs. Direct costs of osteoporotic fractures are expected to surpass $25 billion in 2025, largely attributed to an aging population with an inherently higher risk of fracture. When left untreated, osteoporosis leads to fractures, which can have both physical and emotional consequences on a patient including pain and disability, inability to fully perform routine work or daily activities, and in some cases, result in death. The annual incidence of osteoporotic fractures is higher than that of stroke, heart attack and breast cancer combined; osteoporotic fractures also account for more hospitalizations and associated costs than cardiovascular disease and breast cancer.
Abaloparatide is an investigational therapy for the potential treatment of women with postmenopausal osteoporosis who are at an increased risk for a fracture. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone 1 receptor (PTH1 receptor) and was selected for clinical development based on its favorable bone building activity.
Abaloparatide has completed Phase 3 development for potential use as a daily self-administered injection (abaloparatide-SC). In the fourth quarter of 2015, Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of patients with postmenopausal osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA). Radius submitted a New Drug Application (NDA) for abaloparatide-SC to the US Food and Drug Administration (FDA) at the end of the first quarter of 2016, which has been accepted for filing with a PDUFA date of June 30, 2017. Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for osteoporosis.
About ACTIVE and ACTIVExtend
The Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial was a randomized, double-blind, placebo-controlled, comparative, multicenter, 18 month international study in 2,463 postmenopausal women with osteoporosis designed to evaluate the efficacy and safety of the investigational drug abaloparatide-SC 80 mcg to reduce the risk of vertebral and nonvertebral fractures. Miller PD et al, "Effect of Abaloparatide vs. Placebo on New Vertebral Fractures in Postmenopausal Women With Osteoporosis, A Randomized Clinical Trial" Journal of the American Medical Association 2016 Aug 16;316(7):722-733. ACTIVExtend, an extension of ACTIVE, enrolled patients who had completed 18 months of abaloparatide-SC or placebo in ACTIVE to receive up to 24 additional months of open-label alendronate.
Radius is a science-driven biopharmaceutical company that is committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases. Radius' lead product candidate, the investigational drug abaloparatide for subcutaneous injection, has completed Phase 3 development for potential use in the reduction of fracture risk in postmenopausal women with osteoporosis. Radius' Marketing Authorisation Application (MAA) for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis is under regulatory review in Europe and a New Drug Application (NDA) has been accepted for filing by the FDA with a PDUFA date of June 30, 2017. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in postmenopausal women with osteoporosis and the investigational drug RAD1901 for potential use in hormone-driven and/or hormone-resistant breast cancer, and vasomotor symptoms in postmenopausal women. Radius' preclinical pipeline includes RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in cancer. For more information, please visit 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 without limitation statements regarding expectations for abaloparatide-SC, including without limitation, expectations regarding the clinical significance of clinical trial data for abaloparatide-SC, the potential medical benefit of treatment with abaloparatide-SC for postmenopausal women with osteoporosis, the progress of abaloparatide-SC in the regulatory process with the FDA and the EMA, the incidence of osteoporotic fractures and the health burden associated with osteoporosis, and the potential clinical uses for the abaloparatide transdermal patch, RAD1901 and RAD140.
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: the risk that the results of clinical trials of abaloparatide-SC will not meet regulatory requirements for approval or that regulatory authorities may require additional data or further studies; our dependence on the success of abaloparatide-SC, and our inability to ensure that abaloparatide-SC will obtain regulatory approval or be successfully commercialized; the risk that results of clinical trials of abaloparatide-SC and of our other product candidates may not support product claims, even if approved; failure to achieve market acceptance of abaloparatide-SC, if approved; the availability of coverage and reimbursement for abaloparatide-SC, if approved; 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; failure to establish an effective process for distribution of abaloparatide-SC; and the other important factors discussed under the caption "Risk Factors" in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, or SEC, on February 24, 2017, and in our other reports filed with the SEC, that 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.
Investor Relations Contact: Barbara Ryan Email: firstname.lastname@example.org Phone: 203-274-2825 Media Contact: Lori Gorski Email: Lgorski@radiuspharm.com Phone: 617-551-4096