Benefits seen in Phase III results of BA 058 (abaloparatide) in osteoporosis fracture- Radius health

Radius Health reports top line data from the first six months of ACTIVExtend and the 25 month combined data from ACTIVE and ACTIVExtend testing BA 058 (abaloparatide) in patients with fractures. Additionally, Radius is reporting new data from an exploratory analysis of major osteoporotic fractures in the ACTIVE trial.

Radius previously reported positive results in December 2014 for the Phase III ACTIVE Trial � meeting the primary endpoint of new vertebral fracture reduction (-86%) and secondary endpoints of non-vertebral fracture reduction (-43%) and BMD increases at Spine (18M, 9.20%), Femoral Neck (18M 2.90%) and Total Hip (18M 3.44%). ACTIVExtend results show that the group previously treated with abaloparatide had no new vertebral fractures during the first six months on alendronate. From the start of the ACTIVE study, this group showed an 87% reduction in new vertebral fractures, 52% reduction in non-vertebral fractures, 48% reduction in clinical fractures, and a 58% reduction in major osteoporotic fractures over the 25-month period.

A recent exploratory analysis of the ACTIVE trial showed that, for major osteoporotic fractures, there was a 67% reduction in major osteoporotic fractures for the abaloparatide treatment group versus placebo, and a 53% reduction in major osteoporotic fractures for the abaloparatide treatment group as compared to teriparatide. Over the 25-month period, patients in the abaloparatide-alendronate treatment group on average achieved a 12.8% increase in BMD at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck. In this treatment group, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip, and femoral neck). The adverse events reported during the alendronate treatment period were consistent with previous clinical experience.