18 months of Abaloparatide-SC Treatment Significantly Decreases Incidence of Major Osteoporotic Fractures in Postmenopausal Women When Compared to Teriparatide or Placebo
WALTHAM, Mass., Oct. 10, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) announces positive top-line data from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial, which showed that women with postmenopausal osteoporosis (PMO) who received 18 months of daily abaloparatide (ABL) subcutaneous (SC) injection experienced a 70 percent reduction in the incidence of major osteoporotic fractures compared to placebo. Responder analysis 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 (TPTD) at 6, 12 and 18 months. 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.
"The Phase 3 ACTIVE trial found that women who were taking abaloparatide experienced an early risk reduction for major osteoporotic fractures,” said Dr. Lorraine Fitzpatrick, Chief Medical Officer at Radius Health. “These data could be important to patients who have increased skeletal fragility and greater risk of additional fractures.”
ACTIVE is a randomized, double-blind, placebo controlled Phase 3 trial evaluating fracture prevention in more than 2,400 women suffering from PMO.
Abstract #1053: Effects of Abaloparatide on Major Osteoporotic Fracture Incidence in Postmenopausal Women with Osteoporosis
• PMO women were randomized to receive 18 months of either daily ABL 80-mcg SC, matching placebo SC, or open label TPTD 20-mcg SC. In addition to other endpoints, the study evaluated major osteoporotic fractures, defined as clinical fractures of the forearm, hip, shoulder and clinical spine.
• Compared with placebo-treated subjects, ABL-SC-treated subjects had a 70 percent reduction in major osteoporotic fractures (HR=0.30, 95% CI: 0.15, 0.61; p=0.0004), which was also 55 percent lower compared to TPTD (HR=0.45, 95% CI: 0.21, 0.95; p=0.031). Compared to placebo, TPTD treated subjects did not achieve a statistically significant reduction in clinical, non-vertebral or major osteoporotic fractures.
• Data analysis shows early risk reduction with ABL-SC for major osteoporotic fractures. This is a significant finding because women who already had a fracture are at an increased risk for having another fracture.
Abstract #FRO333: Response Rates for Hip, Femoral Neck and Lumbar Spine BMD are Higher for Patients Treated with Abaloparatide when Compared to Placebo or Teriparatide
• A further analysis of the Phase 3 ACTIVE trial showed greater response rates for BMD at three combined anatomical sites (total hip, femoral neck and lumbar spine) in PMO women treated with ABL-SC for 18 months when compared to placebo or TPTD at 6, 12 and 18 months.
• A patient was considered to be a responder if she had BMD gains greater than 3 percent at the total hip, femoral neck and lumbar spine.
• At month 6, 19.1 percent of ABL-SC-treated patients had BMD increases of >3 percent compared to 0.9 percent for placebo (p<0.0001) and 6.5 percent for TPTD (p<0.0001).
• At month 12, 33.2 percent of ABL-SC-treated patients had BMD increases of >3 percent compared to 1.5 percent for placebo (p<0.0001) or 19.8 percent for TPTD (p<0.0001).
• At month 18, 44.5 percent of ABL-SC treated patients had BMD increases of >3 percent compared to 1.9 percent for placebo (p<0.0001) or 32.0 percent for TPTD (p<0.0001).
In both studies, ABL-SC showed a favorable safety profile and had significantly lower incidence of hypercalcemia than TPTD. The most common adverse reactions that led to study discontinuation of ABL-SC included dizziness, heart palpitations and headaches.
"Broken bones due to osteoporosis are increasingly common in postmenopausal women, and they are a severe public health crisis worldwide because they carry significant health burdens,” said Robert E. Ward, President and Chief Executive Officer at Radius Health. “These data show that abaloparatide has the potential to provide women with a new treatment option to help manage their disease.”
The results from the ACTIVE and ACTIVExtend trials, together with the entire data set from the abaloparatide development program, are subject to regulatory review. Health authorities are the final arbiter of comparative claims against an active comparator that is an approved drug product with approved labeling.
About Osteoporosis
Osteoporosis affects many postmenopausal women since the production of estrogen, a hormone in women that protects bones, decreases sharply when women reach menopause, resulting in bone loss and increasing the risk for a fracture. Approximately one in two women over age 50 will break a bone because of osteoporosis.
The World Health Organization has officially declared osteoporosis a public health crisis. Osteoporosis is a silent disease, often displaying no signs or symptoms until a broken bone occurs. When a woman experiences a fracture, it can often have devastating consequences and make it hard to complete daily activities, such as driving, climbing stairs, or even walking.
These fractures are common and place an enormous medical and personal burden on postmenopausal women. Over 200 million people worldwide suffer from osteoporosis, and 2 million osteoporosis related fractures occur annually in the United States.
The majority of osteoporosis patients remain undiagnosed and undertreated, and there is an unmet medical need for treatment of incident non-vertebral fractures which currently represent 73 percent of all fractures.
About Abaloparatide
Radius Health’s investigational drug abaloparatide is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone-building hormone that has the potential to increase bone mineral density by stimulating new bone formation. Abaloparatide-SC is currently completing Phase 3 development for potential use as a daily self-administered injection for the treatment of patients with postmenopausal osteoporosis, who are at an increased risk for a fracture. Radius is also developing the investigational drug abaloparatide-transdermal for potential use as a short wear-time transdermal patch designed to administer abaloparatide without the need for subcutaneous injection based on 3M's patented Microstructured Transdermal System technology.
About Radius Health
Through cutting-edge science, Radius Health discovers, develops and plans to deliver innovative therapies for the large and underserved osteoporosis patient population, as well as other serious endocrine-mediated diseases including metastatic breast cancer. The Company's lead investigational drug product candidate, abaloparatide, is in development, in both injection (abaloparatide-SC) and transdermal (abaloparatide-TD) methods of administration, for the potential prevention of fractures in postmenopausal women who are at risk of fracture from osteoporosis. The Radius Health clinical portfolio also includes an investigational drug, RAD1901, for the treatment of hormone driven, or hormone resistant, metastatic breast cancer and vasomotor symptoms. For more information, please visit www.radiuspharm.com.
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WALTHAM, Mass., Oct. 10, 2015 (GLOBE NEWSWIRE) -- Radius Health, Inc. (Nasdaq:RDUS) announces positive top-line data from the Phase 3 ACTIVE (Abaloparatide Comparator Trial In Vertebral Endpoints) trial, which showed that women with postmenopausal osteoporosis (PMO) who received 18 months of daily abaloparatide (ABL) subcutaneous (SC) injection experienced a 70 percent reduction in the incidence of major osteoporotic fractures compared to placebo. Responder analysis 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 (TPTD) at 6, 12 and 18 months. 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.
"The Phase 3 ACTIVE trial found that women who were taking abaloparatide experienced an early risk reduction for major osteoporotic fractures,” said Dr. Lorraine Fitzpatrick, Chief Medical Officer at Radius Health. “These data could be important to patients who have increased skeletal fragility and greater risk of additional fractures.”
ACTIVE is a randomized, double-blind, placebo controlled Phase 3 trial evaluating fracture prevention in more than 2,400 women suffering from PMO.
Abstract #1053: Effects of Abaloparatide on Major Osteoporotic Fracture Incidence in Postmenopausal Women with Osteoporosis
• PMO women were randomized to receive 18 months of either daily ABL 80-mcg SC, matching placebo SC, or open label TPTD 20-mcg SC. In addition to other endpoints, the study evaluated major osteoporotic fractures, defined as clinical fractures of the forearm, hip, shoulder and clinical spine.
• Compared with placebo-treated subjects, ABL-SC-treated subjects had a 70 percent reduction in major osteoporotic fractures (HR=0.30, 95% CI: 0.15, 0.61; p=0.0004), which was also 55 percent lower compared to TPTD (HR=0.45, 95% CI: 0.21, 0.95; p=0.031). Compared to placebo, TPTD treated subjects did not achieve a statistically significant reduction in clinical, non-vertebral or major osteoporotic fractures.
• Data analysis shows early risk reduction with ABL-SC for major osteoporotic fractures. This is a significant finding because women who already had a fracture are at an increased risk for having another fracture.
Abstract #FRO333: Response Rates for Hip, Femoral Neck and Lumbar Spine BMD are Higher for Patients Treated with Abaloparatide when Compared to Placebo or Teriparatide
• A further analysis of the Phase 3 ACTIVE trial showed greater response rates for BMD at three combined anatomical sites (total hip, femoral neck and lumbar spine) in PMO women treated with ABL-SC for 18 months when compared to placebo or TPTD at 6, 12 and 18 months.
• A patient was considered to be a responder if she had BMD gains greater than 3 percent at the total hip, femoral neck and lumbar spine.
• At month 6, 19.1 percent of ABL-SC-treated patients had BMD increases of >3 percent compared to 0.9 percent for placebo (p<0.0001) and 6.5 percent for TPTD (p<0.0001).
• At month 12, 33.2 percent of ABL-SC-treated patients had BMD increases of >3 percent compared to 1.5 percent for placebo (p<0.0001) or 19.8 percent for TPTD (p<0.0001).
• At month 18, 44.5 percent of ABL-SC treated patients had BMD increases of >3 percent compared to 1.9 percent for placebo (p<0.0001) or 32.0 percent for TPTD (p<0.0001).
In both studies, ABL-SC showed a favorable safety profile and had significantly lower incidence of hypercalcemia than TPTD. The most common adverse reactions that led to study discontinuation of ABL-SC included dizziness, heart palpitations and headaches.
"Broken bones due to osteoporosis are increasingly common in postmenopausal women, and they are a severe public health crisis worldwide because they carry significant health burdens,” said Robert E. Ward, President and Chief Executive Officer at Radius Health. “These data show that abaloparatide has the potential to provide women with a new treatment option to help manage their disease.”
The results from the ACTIVE and ACTIVExtend trials, together with the entire data set from the abaloparatide development program, are subject to regulatory review. Health authorities are the final arbiter of comparative claims against an active comparator that is an approved drug product with approved labeling.
About Osteoporosis
Osteoporosis affects many postmenopausal women since the production of estrogen, a hormone in women that protects bones, decreases sharply when women reach menopause, resulting in bone loss and increasing the risk for a fracture. Approximately one in two women over age 50 will break a bone because of osteoporosis.
The World Health Organization has officially declared osteoporosis a public health crisis. Osteoporosis is a silent disease, often displaying no signs or symptoms until a broken bone occurs. When a woman experiences a fracture, it can often have devastating consequences and make it hard to complete daily activities, such as driving, climbing stairs, or even walking.
These fractures are common and place an enormous medical and personal burden on postmenopausal women. Over 200 million people worldwide suffer from osteoporosis, and 2 million osteoporosis related fractures occur annually in the United States.
The majority of osteoporosis patients remain undiagnosed and undertreated, and there is an unmet medical need for treatment of incident non-vertebral fractures which currently represent 73 percent of all fractures.
About Abaloparatide
Radius Health’s investigational drug abaloparatide is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone-building hormone that has the potential to increase bone mineral density by stimulating new bone formation. Abaloparatide-SC is currently completing Phase 3 development for potential use as a daily self-administered injection for the treatment of patients with postmenopausal osteoporosis, who are at an increased risk for a fracture. Radius is also developing the investigational drug abaloparatide-transdermal for potential use as a short wear-time transdermal patch designed to administer abaloparatide without the need for subcutaneous injection based on 3M's patented Microstructured Transdermal System technology.
About Radius Health
Through cutting-edge science, Radius Health discovers, develops and plans to deliver innovative therapies for the large and underserved osteoporosis patient population, as well as other serious endocrine-mediated diseases including metastatic breast cancer. The Company's lead investigational drug product candidate, abaloparatide, is in development, in both injection (abaloparatide-SC) and transdermal (abaloparatide-TD) methods of administration, for the potential prevention of fractures in postmenopausal women who are at risk of fracture from osteoporosis. The Radius Health clinical portfolio also includes an investigational drug, RAD1901, for the treatment of hormone driven, or hormone resistant, metastatic breast cancer and vasomotor symptoms. For more information, please visit www.radiuspharm.com.
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