Credit: Shutterstock photoRadius Health, Inc.RDUS announced first six-month data from the ACTIVExtend study along with 25-month combined data from the phase III ACTIVE and ACTIVExtend studies on its lead candidate abaloparatide-SC. The company's shares gained 6.5% following the announcement.
Radius Health is developing abaloparatide-SC for reducing the risk of fracture in postmenopausal women suffering from severe osteoporosis. The company reported that patients who previously completed 18-months treatment with abaloparatide-SC in the phase III ACTIVE study and were receiving alendronate in the ACTIVExtend study (extension to the ACTIVE study) did not undergo new vertebral fractures during the first six-month treatment with alendronate.
The ACTIVExtend study is evaluating 24 months of standard-of-care osteoporosis management in postmenopausal women, after they completed 18-month treatment with abaloparatide-SC or placebo in the ACTIVE study.
Meanwhile, Radius Health revealed new data from an exploratory analysis of major osteoporotic fractures on the ACTIVE study, which showed a 67% reduction in major osteoporotic fractures in the abaloparatide treatment group compared to placebo. Patients in the abaloparatide arm also achieved a 53% reduction in major osteoporotic fractures compared to Eli Lilly's LLY Forteo.
We remind investors that in Dec 2014, Radius Health announced positive 18-month data from the ACTIVE study, showing that abaloparatide-SC led to a statistically significant reduction (86%) in incident vertebral fractures compared to placebo.
Combined data from the 25-month period showed that patients in the abaloparatide-alendronate treatment group on an average achieved an increase in bone mineral density (BMD) at the lumbar spine (12.8%), total hip (5.5%) and femoral neck (4.5%). Moreover, 20.4% of these patients achieved ≥ 6% increase in BMD at all three regions.
Radius Health is currently preparing for the submission of a new drug application for abaloparatide-SC in the U.S. and a marketing authorization application in Europe for the reduction of risk of fracture in postmenopausal women with severe osteoporosis, later this year.
Meanwhile, Radius Health is also developing abaloparatide transdermal patch (abaloparatide-TD) for the treatment of osteoporosis. The company intends to advance abaloparatide-TD to the clinical stage in the second half of 2015.
Radius Health carries a Zacks Rank #3 (Hold). Some better-ranked stocks in the health care sector are Actelion Ltd. ALIOF and Biodel Inc. BIOD . While Actelion carries a Zacks Rank #1 (Strong Buy), Biodel holds a Zacks Rank #2 (Buy).
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The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
