Radius Health Initiates Phase 3 Clinical Trial of Abaloparatide Injection for the Treatment of Male Osteoporosis
- Category: Proteins and Peptides
- Published on Monday, 02 April 2018 20:10
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Bridging study will evaluate change in spine bone mineral density (BMD) at 12 months compared with placebo
WALTHAM, MA, USA I March 30, 2018 I Radius Health, Inc. (Nasdaq:RDUS) announced today that the company has initiated the Phase 3 ATOM (Abaloparatide Treatment for Osteoporosis in Males) study of abaloparatide injection for the treatment of osteoporosis in men.
"Approximately 20 percent of men over the age of 50 years will sustain an osteoporotic-related fracture in their lifetime attributed to multiple risk factors. If successful, this study will serve as the basis of a supplemental New Drug Application (sNDA) seeking to expand the use of abaloparatide to treat men with osteoporosis at high risk for fracture,” said Gary Hattersley, PhD, Chief Scientific Officer of Radius Health. “The study will also include specialized high-resolution imaging to examine the effect of abaloparatide on bone structure, such as the hip, in a subset of the study participants.”
The primary endpoint of the male osteoporosis study is change in lumbar spine bone mineral density (BMD) at 12 months compared with placebo. The randomized, double-blind, placebo-controlled trial will enroll approximately 225 men with osteoporosis.
“Radius’ strategy is to continue to expand the abaloparatide label and innovate on the mechanism of delivery, via our investigational abaloparatide patch, to position the Company as the market leader in osteoporosis,” said Jesper Høiland, President and Chief Executive Officer. “As males represent approximately 10 percent of the total treated osteoporotic patient population, it is important to explore new treatment options for this group of patients.”
Abaloparatide, marketed as TYMLOS™ in the United States, was approved in April 2017 by the US Food and Drug Administration (FDA) for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
INDICATIONS AND USAGE
TYMLOS is indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as a history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. In postmenopausal women with osteoporosis, TYMLOS reduces the risk of vertebral fractures and nonvertebral fractures.
Limitations of Use
Because of the unknown relevance of the rodent osteosarcoma findings to humans, cumulative use of TYMLOS and parathyroid hormone analogs (e.g., teriparatide) for more than 2 years during a patient's lifetime is not recommended.
For the TYMLOS prescribing information, including Boxed Warning, please visit www.tymlospi.com.
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture defined as history of osteoporotic fracture, multiple risk factors for fracture, or patients who have failed or are intolerant to other available osteoporosis therapy. Radius also is developing abaloparatide patch based on 3M's patented Microstructured Transdermal System technology for potential use as a treatment for postmenopausal women with osteoporosis.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics in the areas of osteoporosis and oncology. Radius' lead product, TYMLOS (abaloparatide) injection, was approved by the U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes an investigational abaloparatide patch for potential use in osteoporosis; the investigational drug elacestrant (RAD1901) for potential use in hormone-receptor positive breast cancer; and the investigational drug RAD140, a non-steroidal, selective androgen receptor modulator (SARM) under investigation for potential use in hormone-receptor positive breast cancer. For more information, please visit www.radiuspharm.com.
SOURCE: Radius Health