- Management to host conference call today at 7:30 am ET
WALTHAM, Mass., March 10, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius”) (Nasdaq:RDUS), a science-driven biopharmaceutical company focused on developing novel differentiated therapeutics for patients with osteoporosis as well as other serious endocrine-mediated diseases, including hormone responsive cancers, reported its financial results for the fourth quarter and full year ended December 31, 2014, and provided recent corporate highlights. As of December 31, 2014, Radius had cash, cash equivalents and marketable securities of $105.3 million, and in a public offering on January 28, 2015 raised an additional $158.6 million, net of underwriting discounts and estimated offering costs.
“Radius achieved a number of significant milestones in 2014 and early 2015, including our IPO, and two successful follow-on offerings,” said Robert Ward, President and Chief Executive Officer of Radius Health. “In addition, we recently announced the top-line results for our Phase 3 (“ACTIVE”) clinical trial evaluating the investigational drug abaloparatide-SC, a novel synthetic peptide analog or PTHrP, which demonstrated a statistically significant 86% reduction in new vertebral fractures in postmenopausal women with osteoporosis. We believe we are on-track to submit an NDA in the United States and an MAA in Europe during the second half of 2015. We are also very pleased to have begun recruitment for a Phase 1 study for the investigational drug RAD1901 to evaluate its potential in the treatment of metastatic breast cancer. We are now turning our attention to engaging a global collaborator and preparing for regulatory review of abaloparatide-SC. Pending regulatory approval, these actions are expected to lead to commercial launch next year.”
Pipeline Update
Abaloparatide-SC
On March 5, 2015, Dr. Paul Miller, the Medical Director at the Colorado Center for Bone Research, presented the positive results of our Phase 3 ACTIVE clinical trial of the investigational drug abaloparatide-SC at a Late Breaker session at the ENDO meeting, the world’s largest meeting of endocrinologists. Dr. Miller was a lead investigator in the ACTIVE trial, is an internationally recognized physician specializing in metabolic bone disease, and is considered to be a leading authority on bone biology and the treatment of osteoporosis. Previously, Radius reported positive top-line results from the 18-month ACTIVE clinical trial, in which abaloparatide-SC met the primary endpoint with a statistically significant 86% reduction in new vertebral fractures versus placebo, and in which teriperatide met the same endpoint with a statistically significant 80% reduction. On the secondary endpoints, as compared to placebo, abaloparatide achieved a statistically significant fracture-rate reduction of 43% in the adjudicated non-vertebral fracture subset of patients; a statistically significant reduction of 45% in the adjudicated clinical fracture group; and a significant difference in the time to first incident of non-vertebral fracture in both the adjudicated non-vertebral fracture and the clinical fracture subset of patients in this trial.
In addition to the Phase 3 ACTIVE clinical trial, the first six months of the extension clinical trial (“ACTIVExtend”) is designed to enable Radius to obtain 24 months of fracture data, as requested by the Food and Drug Administration (“FDA”). ACTIVExtend is a single 24-month extension study and the first six months will be combined with the Phase 3 ACTIVE results to provide 24-month data in the new drug application (“NDA”) to be submitted to the FDA. Patients from the abaloparatide-SC and placebo groups from the ACTIVE clinical trial were eligible to continue in ACTIVExtend, in which they are receiving an approved alendronate therapy for osteoporosis management. Radius currently anticipates that the results from the first six months of the ACTIVExtend trial will be available in the second quarter of 2015, and believes that it is on-track for submission of an NDA for abaloparatide-SC to the FDA, and submission of a marketing authorization application (“MAA”) to the European Medicines Agency (“EMA”), in the second half of 2015, with regulatory action on the NDA and MAA anticipated in 2016.
The investigational drug abaloparatide-TD is a short wear time transdermal patch form of abaloparatide also under development. In December 2014, Radius announced that in preliminary, nonhuman primate pharmacokinetic studies, prototype A7 achieved a desirable pharmacokinetic profile, with comparable AUC, Cmax, Tmax and T1/2 relative to abaloparatide-SC. Radius expects to initiate the clinical evaluation of the optimized abaloparatide-TD patch in the second half of 2015, with the goal of achieving comparability to abaloparatide-SC. Radius holds worldwide commercialization rights to abaloparatide-TD technology.
Radius believes that abaloparatide is the most advanced PTHrP analog in clinical development for potential use in the treatment of osteoporosis and that, subject to regulatory review and approval, it could have the potential to provide advantages over other current standard of care treatments for osteoporosis.
RAD1901
In December 2014, Radius commenced a Phase 1 clinical trial of the investigational drug RAD1901 in the United States for potential use in the treatment of metastatic breast cancer. The Phase 1 study is a multicenter, open-label, two-part, dose-escalation study of RAD1901 in postmenopausal women with advanced estrogen receptor positive and HER2-negative breast cancer that is designed to determine the recommended dose for a Phase 2 study and includes a preliminary evaluation of the potential anti-tumor effect of RAD1901. Radius expects to report progress on this study in the first half of 2015 and to initiate an additional Phase 1 clinical trial in the European Union in 2015.
Radius believes there could be a significant therapeutic opportunity for RAD1901, as it may, subject to successful development, regulatory review and approval, offer possible advantages over the current standard of care for patients with metastatic breast cancer. Radius is also developing RAD1901 at lower doses as a SERM, for potential use in the treatment of vasomotor symptoms. Historically, hormone replacement therapy (“HRT”) with estrogen or progesterone has been considered the most efficacious approach to relieving menopausal symptoms such as hot flashes. However, because of the concerns about the potential long‑term risks and contraindications associated with HRT, Radius believes a significant need exists for new therapeutic treatment options to treat vasomotor symptoms. In a Phase 2 proof of concept study, RAD1901 at lower doses demonstrated a reduction in the frequency and severity of moderate and severe hot flashes. Radius intends to commence a Phase 2b clinical trial in vasomotor symptoms in the second half of 2015.
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