- Investigational drug abaloparatide-SC shows continued clinical benefit across the 25-month period with significant reductions in vertebral, nonvertebral, clinical and major osteoporotic fractures.
- In the first six months of ACTIVExtend, patients who previously completed 18 months of abaloparatide-SC administration experienced no new vertebral fractures.
- Radius believes that the positive results from the ACTIVE and ACTIVExtend trials have met the primary and secondary endpoints essential for submission of the NDA and MAA in 2015.
- Company to Host Webcast Tomorrow (Thursday, June 18, 2015) at 8:30 a.m. ET
WALTHAM, MA, USA I June 17, 2015 I Radius Health, Inc. (RDUS) reports top line data from the first six months of ACTIVExtend and the 25 month combined data from ACTIVE and ACTIVExtend. Additionally, Radius is reporting new data from an exploratory analysis of major osteoporotic fractures in the ACTIVE trial.
Radius previously reported positive results in December 2014 for the Phase 3 ACTIVE Trial — meeting the primary endpoint of new vertebral fracture reduction (-86%, p < 0.0001) and secondary endpoints of non-vertebral fracture reduction (-43%, p = 0.0489) and BMD increases at Spine (18M, 9.20% p < 0.0001), Femoral Neck (18M 2.90% p < 0.0001) and Total Hip (18M 3.44% p < 0.0001).
ACTIVExtend results show that the group previously treated with abaloparatide had no new vertebral fractures during the first six months on alendronate. From the start of the ACTIVE study, this group showed an 87% reduction in new vertebral fractures (p < 0.0001), 52% reduction in non-vertebral fractures (p = 0.0168), 48% reduction in clinical fractures (p = 0.0139), and a 58% reduction in major osteoporotic fractures (p = 0.0122) over the 25-month period. A recent exploratory analysis of the ACTIVE trial showed that, for major osteoporotic fractures, there was a 67% reduction in major osteoporotic fractures (p = 0.0014) for the abaloparatide treatment group versus placebo, and a 53% reduction in major osteoporotic fractures (p = 0.0437) for the abaloparatide treatment group as compared to teriparatide.
Over the 25-month period, patients in the abaloparatide-alendronate treatment group on average achieved a 12.8% increase in BMD at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck. In this treatment group, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip, and femoral neck).
The adverse events reported during the alendronate treatment period were consistent with previous clinical experience.
| |
|
|
| |
Prior Placebo |
Prior Abaloparatide |
| Arthralgia |
4.7% |
4.3% |
| Dyspepsia |
2.2% |
2.7% |
| Upper respiratory infection |
4.5% |
2.5% |
| Urinary tract infection |
1.0% |
2.4% |
| Bone pain |
1.2% |
2.2% |
“We are extremely pleased with the consistency of the positive results of both the ACTIVE and ACTIVExtend trials, which support the potential use of abaloparatide for the treatment of postmenopausal osteoporosis,” said Robert E. Ward, Radius President and Chief Executive Officer. “We are excited about continuing our active dialogue with health authorities as we prepare our regulatory submissions.”
Osteoporosis is a major public health concern with substantial health and economic burden. The International Osteoporosis Foundation estimates that over 200 million people worldwide suffer from osteoporosis causing more than 8.9 million fractures annually, or one every three seconds. In the US alone, there are over 2 million fractures annually, and they are most prevalent at the hip, spine and wrist. The majority of osteoporosis patients remain undiagnosed and undertreated, and there is an unmet medical need for incident non-vertebral fractures which currently represent 73% of all fractures, and for which current therapies are considered inadequate.
There are two categories of osteoporosis medications: antiresorptive medications that slow bone loss and anabolic drugs that increase the rate of bone formation. Bisphosphonates, calcitonin, denosumab, estrogen and estrogen agonists/antagonists are antiresorptive medicines and slow bone loss. Teriparatide, a form of parathyroid hormone, is an anabolic drug, and currently the only osteoporosis medicine approved by the FDA that rebuilds bone. In 2014, global sales of osteoporosis therapies totaled $6.4 billion, $2.3 billion of which was for injectable drugs.
About ACTIVExtend
ACTIVExtend is an extension study to evaluate 24 months of standard-of-care osteoporosis management following completion of 18 months of abaloparatide-SC or placebo treatment in the Phase 3 ACTIVE trial.
About ACTIVE Results
On the primary endpoint of reduction of new vertebral fractures, abaloparatide-SC (n=690, fracture rate 0.58%) achieved a statistically significant 86% reduction as compared to the placebo-treated group (n=711, fracture rate 4.22%) (p<0.0001). The open-label teriparatide injection treatment group (n=717, fracture rate 0.84%) showed a statistically significant 80% reduction of new vertebral fractures (excluding worsening) as compared to the placebo-treated group (p<0.0001). For the secondary endpoint of non-vertebral fractures, abaloparatide-SC (n=824, Kaplan-Meier estimated, or KM, fracture rate 2.7%) achieved a statistically significant reduction compared to the placebo-treated group (n=821, KM fracture rate 4.7%), and the hazard ratio for abaloparatide vs. placebo was 0.57 (p=0.0489); the open label teriparatide injection treatment group (n=818, KM fracture rate 3.3%) had a hazard ratio of 0.72 (NS) compared to the placebo-treated group.
Abaloparatide-SC treated patients had a statistically significant reduction in major osteoporotic fractures versus both placebo and teriparatide, of 67% and 53% respectively, and a statistically significant reduction of 72% in wrist fractures versus teriparatide.
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 Radius
Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases. Radius’ lead development candidate is the investigational drug abaloparatide (BA058) for subcutaneous injection, which is completing Phase 3 development for the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for the treatment of osteoporosis and the investigational drug RAD1901 for the treatment of hormone driven, or hormone resistant, metastatic breast cancer. www.radiuspharm.com
About the Investigational Drug Abaloparatide
Radius’ investigational drug abaloparatide is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone-building hormone that we believe has the potential to increase bone mineral density by stimulating new bone formation. Abaloparatide-SC is an investigational drug currently completing Phase 3 development for potential use as a daily self-administered injection for the treatment of patients with postmenopausal osteoporosis at high risk of fracture. Radius also is developing the investigational drug abaloparatide-TD 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.
SOURCE: Radius Health
Post Views: 45
- Investigational drug abaloparatide-SC shows continued clinical benefit across the 25-month period with significant reductions in vertebral, nonvertebral, clinical and major osteoporotic fractures.
- In the first six months of ACTIVExtend, patients who previously completed 18 months of abaloparatide-SC administration experienced no new vertebral fractures.
- Radius believes that the positive results from the ACTIVE and ACTIVExtend trials have met the primary and secondary endpoints essential for submission of the NDA and MAA in 2015.
- Company to Host Webcast Tomorrow (Thursday, June 18, 2015) at 8:30 a.m. ET
WALTHAM, MA, USA I June 17, 2015 I Radius Health, Inc. (RDUS) reports top line data from the first six months of ACTIVExtend and the 25 month combined data from ACTIVE and ACTIVExtend. Additionally, Radius is reporting new data from an exploratory analysis of major osteoporotic fractures in the ACTIVE trial.
Radius previously reported positive results in December 2014 for the Phase 3 ACTIVE Trial — meeting the primary endpoint of new vertebral fracture reduction (-86%, p < 0.0001) and secondary endpoints of non-vertebral fracture reduction (-43%, p = 0.0489) and BMD increases at Spine (18M, 9.20% p < 0.0001), Femoral Neck (18M 2.90% p < 0.0001) and Total Hip (18M 3.44% p < 0.0001).
ACTIVExtend results show that the group previously treated with abaloparatide had no new vertebral fractures during the first six months on alendronate. From the start of the ACTIVE study, this group showed an 87% reduction in new vertebral fractures (p < 0.0001), 52% reduction in non-vertebral fractures (p = 0.0168), 48% reduction in clinical fractures (p = 0.0139), and a 58% reduction in major osteoporotic fractures (p = 0.0122) over the 25-month period. A recent exploratory analysis of the ACTIVE trial showed that, for major osteoporotic fractures, there was a 67% reduction in major osteoporotic fractures (p = 0.0014) for the abaloparatide treatment group versus placebo, and a 53% reduction in major osteoporotic fractures (p = 0.0437) for the abaloparatide treatment group as compared to teriparatide.
Over the 25-month period, patients in the abaloparatide-alendronate treatment group on average achieved a 12.8% increase in BMD at the lumbar spine, a 5.5% increase in BMD at total hip, and a 4.5% increase in BMD at the femoral neck. In this treatment group, 20.4% of patients achieved a 6% increase or greater in BMD at all three sites (i.e., lumbar spine, total hip, and femoral neck).
The adverse events reported during the alendronate treatment period were consistent with previous clinical experience.
| |
|
|
| |
Prior Placebo |
Prior Abaloparatide |
| Arthralgia |
4.7% |
4.3% |
| Dyspepsia |
2.2% |
2.7% |
| Upper respiratory infection |
4.5% |
2.5% |
| Urinary tract infection |
1.0% |
2.4% |
| Bone pain |
1.2% |
2.2% |
“We are extremely pleased with the consistency of the positive results of both the ACTIVE and ACTIVExtend trials, which support the potential use of abaloparatide for the treatment of postmenopausal osteoporosis,” said Robert E. Ward, Radius President and Chief Executive Officer. “We are excited about continuing our active dialogue with health authorities as we prepare our regulatory submissions.”
Osteoporosis is a major public health concern with substantial health and economic burden. The International Osteoporosis Foundation estimates that over 200 million people worldwide suffer from osteoporosis causing more than 8.9 million fractures annually, or one every three seconds. In the US alone, there are over 2 million fractures annually, and they are most prevalent at the hip, spine and wrist. The majority of osteoporosis patients remain undiagnosed and undertreated, and there is an unmet medical need for incident non-vertebral fractures which currently represent 73% of all fractures, and for which current therapies are considered inadequate.
There are two categories of osteoporosis medications: antiresorptive medications that slow bone loss and anabolic drugs that increase the rate of bone formation. Bisphosphonates, calcitonin, denosumab, estrogen and estrogen agonists/antagonists are antiresorptive medicines and slow bone loss. Teriparatide, a form of parathyroid hormone, is an anabolic drug, and currently the only osteoporosis medicine approved by the FDA that rebuilds bone. In 2014, global sales of osteoporosis therapies totaled $6.4 billion, $2.3 billion of which was for injectable drugs.
About ACTIVExtend
ACTIVExtend is an extension study to evaluate 24 months of standard-of-care osteoporosis management following completion of 18 months of abaloparatide-SC or placebo treatment in the Phase 3 ACTIVE trial.
About ACTIVE Results
On the primary endpoint of reduction of new vertebral fractures, abaloparatide-SC (n=690, fracture rate 0.58%) achieved a statistically significant 86% reduction as compared to the placebo-treated group (n=711, fracture rate 4.22%) (p<0.0001). The open-label teriparatide injection treatment group (n=717, fracture rate 0.84%) showed a statistically significant 80% reduction of new vertebral fractures (excluding worsening) as compared to the placebo-treated group (p<0.0001). For the secondary endpoint of non-vertebral fractures, abaloparatide-SC (n=824, Kaplan-Meier estimated, or KM, fracture rate 2.7%) achieved a statistically significant reduction compared to the placebo-treated group (n=821, KM fracture rate 4.7%), and the hazard ratio for abaloparatide vs. placebo was 0.57 (p=0.0489); the open label teriparatide injection treatment group (n=818, KM fracture rate 3.3%) had a hazard ratio of 0.72 (NS) compared to the placebo-treated group.
Abaloparatide-SC treated patients had a statistically significant reduction in major osteoporotic fractures versus both placebo and teriparatide, of 67% and 53% respectively, and a statistically significant reduction of 72% in wrist fractures versus teriparatide.
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 Radius
Radius is a science-driven biopharmaceutical company developing new therapeutics for patients with advanced osteoporosis as well as other serious endocrine-mediated diseases. Radius’ lead development candidate is the investigational drug abaloparatide (BA058) for subcutaneous injection, which is completing Phase 3 development for the reduction of fracture risk in postmenopausal women with severe osteoporosis. The Radius clinical portfolio also includes an investigational abaloparatide transdermal patch for the treatment of osteoporosis and the investigational drug RAD1901 for the treatment of hormone driven, or hormone resistant, metastatic breast cancer. www.radiuspharm.com
About the Investigational Drug Abaloparatide
Radius’ investigational drug abaloparatide is a synthetic peptide analog of human parathyroid hormone-related protein (hPTHrP), a naturally occurring bone-building hormone that we believe has the potential to increase bone mineral density by stimulating new bone formation. Abaloparatide-SC is an investigational drug currently completing Phase 3 development for potential use as a daily self-administered injection for the treatment of patients with postmenopausal osteoporosis at high risk of fracture. Radius also is developing the investigational drug abaloparatide-TD 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.
SOURCE: Radius Health
Post Views: 45
