Radius Health Is Very Much Active...

(RTTNews) - Radius Health Inc.'s (RDUS) phase III trial of its product candidate Abaloparatide-SC has demonstrated success in reducing fractures in women with postmenopausal osteoporosis.

Osteoporosis is a disease where bone mass decreases quicker than the body can replace it, leading to greater fragility and an increase in fracture risk. Postmenopausal osteoporosis is the most common form of osteoporosis. According to the National Osteoporosis Foundation, one in two women older than 50 is predicted to break a bone due to osteoporosis in her remaining lifetime.

In Radius Health's phase III trial, dubbed ACTIVE, patients were randomized to receive either Abaloparatide SC daily injection or placebo or an active comparator Teriparatide (marketed by Eli Lilly under the name Forteo).

Abaloparatide, administered through a subcutaneous injection, is a new synthetic peptide analog of hPTHrP (human parathyroid hormone-related protein), a naturally occurring bone building hormone.

While the Abaloparatide-SC treatment arm achieved a statistically significant 83% reduction of incident vertebral fractures compared to the placebo-treated group, the Teriparatide injection treatment group showed a statistically significant 78% reduction of incident vertebral fractures compared to the placebo-treated group.

An extension of the ACTIVE trial, known as ACTIVExtend, to evaluate 24 months of standard-of-care osteoporosis management in Abaloparatide-SC treated and placebo groups is underway.

The first six-month results from the ongoing ACTIVExtend trial are expected in the second quarter of 2015. Upon completion of the full 24 months of treatment exposure, the combined data set from ACTIVE and ACTIVExtend will be unblinded for data analysis, says the company.

Radius Health hopes to submit the NDA for Abaloparatide SC for use in the reduction of fractures in postmenopausal osteoporosis in the second half of 2015.

Seeking to improve patient compliance with convenience and ease of use of Abaloparatide, the company is also developing Abaloparatide-TD, a next-generation, short-wear-time transdermal patch.

The company completed a successful phase II proof of concept study of Abaloparatide-TD in January of this year - where Abaloparatide-TD demonstrated a statistically significant mean percent increase from baseline in bone mineral density compared to placebo at the lumbar spine and at the hip.

We alerted our premium subscribers to RDUS on October 20, 2014 when it was trading around $18. The stock touched a new high of $32.82 on December 18, 2014, and that is a gain of 82% in just two months.

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