Radius Health: Enrollment Completed for Phase 3 wearABLe trial
- Innovative transdermal technology enables delivery of abaloparatide molecule – a peptide - across the skin
- Trial success followed by regulatory approval would provide a completely unique drug administration option for postmenopausal women with osteoporosis.
- wearABLe progress follows recent male study enrollment completion
WALTHAM, Mass., Sept. 08, 2020 (GLOBE NEWSWIRE) -- Radius Health, Inc. (“Radius” or the “Company”) (Nasdaq: RDUS) today announced completion of enrollment in its “wearABLe” phase 3 trial.
The study was designed to look at the effects on bone mineral density of abaloparatide delivered via a novel transdermal device (“abaloparatide-patch”) compared with the current subcutaneous formulation, marketed as TYMLOS®. The study aimed to enroll 474 postmenopausal women with osteoporosis at high risk for fracture. Actual patients enrolled, based on demand, was approximately 500. These patients will be treated for 12 months and have a further one month on study for safety assessment at the completion of 12 months of therapy.
“We are delighted to have completed enrollment of the wearABLe study,” commented Dr. Charles Morris, Radius’ Chief Medical Officer. “This brings us one step closer to potentially having the ability to deliver osteoanabolic therapy through an alternative to daily subcutaneous injection,” he continued. “I am grateful to our teams, our investigators, and their patients who have helped us reach this milestone. We will share top-line data results in the fourth quarter of 2021.”
The abaloparatide-patch leverages the technology advances of the solid microstructured transdermal system, which was developed by Kindeva Drug Delivery, a spin-out of the 3M Corporation. This technology innovation allows the successful delivery of peptides – in our case, abaloparatide - across the skin. To date, this has not been proven possible by traditional transdermal patch capabilities.
This initiative was designed as a patient-centric approach and differentiating strategy for Radius as part of a multi – year partnership with Kindeva/3M. A successful trial and subsequent regulatory approval would provide patients with a new option of abaloparatide administration. Such an option is typically not available for biological products.
“This drug delivery technology is being developed to provide a favorable experience for patients with osteoporosis treated with TYMLOS,” commented Dr. Bruce Mitlak, recently named Head of Discovery Science for the areas of musculoskeletal, endocrinology, and metabolic for Radius.
Radius is a science-driven fully integrated biopharmaceutical company that is committed to developing and commercializing innovative endocrine therapeutics.
For more information, please visit www.radiuspharm.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.
About Abaloparatide-Patch and wearABLe Phase 3 Study
Abaloparatide-patch was developed in a collaboration between Radius and Kindeva Drug Delivery (“Kindeva”) (formerly 3M Drug Delivery Systems) with the application of Kindeva’s innovative microstructured transdermal patch technology. The Phase 3 wearABLe abaloparatide-patch study is the first pivotal study to evaluate treatment using a novel non-injectable delivery of an anabolic therapy. The wearABLe Phase 3 study is a pivotal, randomized, open label, active-controlled, bone mineral density (“BMD”) non-inferiority bridging study that will evaluate the efficacy and safety of abaloparatide-patch versus TYMLOS (abaloparatide injection) in approximately 500 patients with postmenopausal osteoporosis at high risk for fracture. The primary endpoint of the study is the percentage change in lumbar spine BMD at 12 months.
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