WALTHAM, Mass., April 01, 2016 (GLOBE NEWSWIRE) — Radius Health, Inc. (Nasdaq:RDUS), a science-driven biopharmaceutical company committed to developing innovative therapeutics in the areas of osteoporosis, oncology and endocrine diseases, today announced results from pre-specified subgroup analyses from its Phase 3 ACTIVE trial. The results demonstrate that Radius’ investigational drug, abaloparatide-SC injection, reduced the risk of vertebral and nonvertebral fractures and increased bone mineral density (BMD) consistently in postmenopausal women with osteoporosis regardless of baseline patient characteristics. These data were presented today at the Endocrine Society (ENDO) 2016 Annual Meeting in Boston. Radius will also present an update at the Meeting on investigational drug RAD1901, a novel oral estrogen receptor ligand being studied at low doses for potential treatment of moderate to severe hot flashes (vasomotor symptoms) associated with menopause.
“Results from the Phase 3 ACTIVE subgroup analyses suggest that the investigational drug abaloparatide-SC reduces the risk of both vertebral and nonvertebral fractures and improves BMD consistently across a range of baseline patient characteristics, including age, baseline bone mineral density, and prior fracture history,” said Felicia Cosman, M.D., osteoporosis specialist and Medical Director of the Clinical Research Center at Helen Hayes Hospital, Senior Clinical Director of the National Osteoporosis Foundation, Professor of Medicine at Columbia University and consultant to Radius. “The safety and efficacy clinical trial data shown to date demonstrate that, if approved, the novel investigational bone anabolic, abaloparatide-SC, has the potential to address the needs of many postmenopausal women with osteoporosis.”
The Phase 3 ACTIVE trial is 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 in the reduction of risk of vertebral and nonvertebral fractures.
About Radius Health
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-SC, 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) was submitted in the U.S. at the end of the first quarter of 2016. The Radius clinical pipeline also includes an investigational abaloparatide transdermal patch for potential use in 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 multiple applications including cancer. For more information, please visit www.radiuspharm.com.
About Abaloparatide
Abaloparatide is an investigational therapy for the potential treatment of postmenopausal women with osteoporosis. Abaloparatide is a novel synthetic peptide that engages the parathyroid hormone 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). At the end of the first quarter of 2016, Radius submitted an NDA for abaloparatide-SC to the US Food and Drug Administration for the treatment of postmenopausal women with osteoporosis. In the fourth quarter of 2015, Radius’ MAA for abaloparatide-SC for the treatment of postmenopausal women with osteoporosis was validated and is currently undergoing regulatory review by the European Medicines Agency (EMA).
Radius also is developing abaloparatide-transdermal (abaloparatide-TD) based on 3M’s patented Microstructured Transdermal System technology for potential use as a short wear-time transdermal patch.
About RAD1901
RAD1901 is a selective estrogen receptor down-regulator/degrader (SERD), which is being evaluated at high doses for potential use as an oral non-steroidal treatment for hormone-driven, or hormone-resistant, breast cancer. RAD1901 is currently being investigated for potential use in postmenopausal women with advanced estrogen receptor positive (ER+), HER2-negative breast cancer, the most common form of the disease. Studies completed to date indicate that the compound has the potential for use as a single agent or in combination with other therapies to overcome endocrine resistance in breast cancer.
RAD1901 also is being evaluated in a Phase 2b study at low doses for potential relief of the frequency and severity of moderate to severe hot flashes in postmenopausal women with vasomotor symptoms. Additional information on the clinical trial program of RAD1901 is available on www.clinicaltrials.gov.
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, including data from the subgroup analyses of the phase 3 ACTIVE trial, 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, 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 25, 2016, 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.
CONTACT: Media Contact: Lori Gorski Email: Lgorski@radiuspharm.com Phone: 617-551-4096 Investor Relations Contact: Barbara Ryan Email: bryan@radiuspharm.com Phone: 203-274-2825
