Radius Health: Enrollment Completed for Phase 3 wearABLe Trial
Waltham, MA/(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.