Radius Health announces positive Phase 3 top-line results for its investigational drug abaloparatide-sc in postmenopausal women with severe osteoporosis
5:56 AM ET 12/22/14 | Briefing.com
On the primary endpoint, the investigational drug abaloparatide-SC (n=690, fracture rate 0.72%) achieved a statistically significant 83% reduction of incident vertebral fractures as compared to the placebo-treated group (n=711, fracture rate 4.36%) (p<0.0001). The ACTIVE trial included an open-label teriparatide [rDNA origin] injection treatment group (n=717, fracture rate 0.98%) that showed a statistically significant 78% reduction of incident vertebral fractures as compared to the placebo-treated group (p<0.0001). On the secondary endpoints as compared to placebo, abaloparatide-SC achieved a statistically significant fracture-rate reduction of 43% in the adjudicated non-vertebral fracture subset of patients; a statistically significant reduction of 41% in the adjudicated clinical fracture group, which includes both vertebral and non-vertebral fractures; and a statistically significant difference in the time to first incident non-vertebral fracture in both the adjudicated non-vertebral fracture and the clinical fracture subset of patients.
"We are on track for NDA submission in the second half of 2015 and encouraged by the consistency of our Phase 3 results with those from our two Phase 2 studies...These results reinforce the emerging profile of abaloparatide, and we eagerly await the first six-month results from the ongoing ACTIVExtend trial expected in the second quarter of 2015."
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