Radius Reports Positive Phase3 Results For Investigational Drug Abaloparatide-SC

(RTTNews) - Radius Health Inc. (RDUS) announced positive top-line 18-month fracture results from the Company's Phase 3 clinical trial or ACTIVE evaluating the investigational drug abaloparatide-SC for potential use in the reduction of fractures in postmenopausal osteoporosis.

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," said Robert Ward, Radius President and Chief Executive Officer.

Radius said that it has made significant progress towards the development of an optimized, short-wear-time transdermal patch, for its investigational drug abaloparatide-TD based on 3M Drug Delivery Systems' sMTS platform. Together with 3M Drug Delivery Systems, Radius evaluated a number of new TD patch configurations with the goal of selecting a configuration that may be capable of demonstrating therapeutic comparability to abaloparatide-SC injection.

In preliminary, non-human primate pharmacokinetic studies, prototype A7 achieved a desirable pharmacokinetic profile, with comparable AUC and Cmax relative to the investigational abaloparatide-SC program. The company believe that these results support continued clinical development toward future global regulatory submissions as a potential post-approval line extension of the investigational drug abaloparatide-SC.