Radius Provides Update on Pivotal Phase 3 Program for BA058-SC Injection
Published: Jan 07, 2013
CAMBRIDGE, MA--(Marketwire - January 07, 2013) -
An interim safety analysis was performed by the independent Data Safety Monitoring Board (DSMB) as part of its routine oversight of the pivotal Phase 3 study. At the latest meeting in November, the DSMB reviewed accumulated safety data on more than 75 percent of the planned 2,400 subjects and recommended that the trial continue unmodified. There have been no SAEs to date attributed to BA058.
As part of this DSMB review, a blinded analysis was performed on safety reports of clinical, non-vertebral fractures occurring in the study. The blinded (BA058/Placebo) versus open label (Forteo) arm has shown a lower non-vertebral fracture rate (1.2 percent in the blinded BA058/Placebo arm versus 1.9 percent in the Forteo arm).
"With the DSMB recommendation and the emerging blinded, interim fracture data, we believe that our Phase 3 trial is on track to demonstrate potentially favorable results in preventing non-vertebral fractures in postmenopausal women with osteoporosis at high risk for fracture," said Michael Wyzga, Radius president and chief executive officer.
The Phase 3 randomized, double-blind trial, which commenced enrollment in April 2011, is expected to enroll 2,400 patients and is studying BA058-SC as a daily subcutaneous injection in comparison to placebo and Forteo for safety and efficacy in preventing vertebral fractures as its primary endpoint (See Clinicaltrials.gov). The Phase 3 pivotal trial is projected to complete enrollment in the first quarter of 2013.
Currently, there are 29 clinical centers in 10 countries participating in this Phase 3 study, and all planned clinical centers are open. The earliest enrolling patients have completed the primary 18-month treatment phase of the program and have now enrolled into the 6-month extension study.
Additionally, Radius has met with the Swedish Medical Products Agency (MPA) to review the design and the overall progress of the Phase 3 program. The MPA has confirmed that the program, based on the current single pivotal trial design, would support the submission and potential approval of an MAA in Europe, pending the results of the Phase 3 study.
About Radius Health
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. Radius also has a product in development to treat symptoms associated with menopause. Learn more by visiting the company's new website at www.RadiusPharm.com
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 number of patients expected to be enrolled in the ongoing Phase 3 trial, the projected date by which the ongoing Phase 3 trial will be fully enrolled and the prospects for BA058-SC and BA058-TD, 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.