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Radius Provides Update on Pivotal Phase 3 Program for BA058-SC Injection
By: Marketwired .
Jan. 7, 2013 11:15 AM
CAMBRIDGE, MA -- (Marketwire) -- 01/07/13 -- Radius Health, Inc. ("Radius"), a biopharmaceutical company focused on developing new therapeutics for the treatment of osteoporosis and other women's health conditions, is providing an update regarding the progress of its Phase 3 study of BA058-Subcutaneous (SC). BA058 is a novel synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein), an anabolic, bone-building drug being studied for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
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.
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