Radius Health, Inc. provided an update regarding the progress of its Phase 3 study of BA058-Subcutaneous. BA058 is a novel synthetic peptide analog of hPTHrP, 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 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% 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 arm has shown a lower non-vertebral fracture rate. 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. The Phase 3 pivotal trial is projected to complete enrollment in the first quarter of 2013.

Additionally, Radius has met with the Swedish Medical Products Agency 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.