Positive results in phase III trial of BA 058 (abaloparatide subcutaneous) in patients with postmenopausal osteoporosis- Radius Health

Radius Health has announced positive top-line data from the Phase III ACTIVE trial, which showed that women with postmenopausal osteoporosis (PMO) who received 18 months of daily BA 058 (abaloparatide subcutaneous or ABL-SC) injection experienced a 70% reduction in the incidence of major osteoporotic fractures compared to placebo.

Responder analysis also showed greater increases in bone mineral density (BMD) at three combined anatomical sites (total hip, femoral neck and lumbar spine) compared to placebo or teriparatide (Forsteo) at 6, 12 and 18 months. Data analysis shows early risk reduction with ABL-SC for major osteoporotic fractures. This could be a significant finding because women who already had a fracture are at an increased risk for having another fracture. In both studies, ABL-SC showed a favourable safety profile and had significantly lower incidence of hypercalcaemia than TPTD. The most common adverse reactions that led to study discontinuation of ABL-SC included dizziness, heart palpitations and headaches.

ACTIVE is a randomised, double-blind, placebo controlled Phase III trial evaluating fracture prevention in more than 2,400 women suffering from PMO. These results, along with positive pharmacokinetic data from a study evaluating the ABL transdermal patch, were presented during the American Society for Bone and Mineral Research (ASBMR) 2015 Annual Meeting as oral and poster presentations, respectively.

Comment: Radius is also developing the investigational drug abaloparatide-TD for potential use as a short wear-time transdermal patch (based on 3M's patented Microstructured Transdermal System technology), designed to administer abaloparatide without the need for subcutaneous injection.