Radius Health: Enrollment Completed for Phase 3 wearABLe trial

Rhea-AI Summary

Radius Health, Inc. (Nasdaq: RDUS) announced the completion of enrollment in its phase 3 'wearABLe' trial, assessing a novel transdermal abaloparatide patch for postmenopausal women with osteoporosis. Approximately 500 women were enrolled, exceeding the target of 474. The trial aims to evaluate the patch's efficacy compared to the subcutaneous TYMLOS injection over 12 months. The top-line data results are expected in Q4 2021. This innovative delivery method could offer a unique alternative for patients, marking a significant step in treating osteoporosis.

Positive

• Completion of enrollment in the wearABLe phase 3 trial with approximately 500 patients vs. 474 target.
• Potential to deliver osteoanabolic therapy via a non-invasive method, improving patient experience.
• Anticipated top-line data release in Q4 2021, indicating progress toward FDA approval.

Negative

• None.

• 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.

About 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.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements.

These forward-looking statements are based on management's current expectations. These statements involve known and unknown risks and uncertainties that may cause our actual results, performance or achievements to be materially different from any expressed or implied by the forward-looking statements. These risks include, but are not limited to, the following: the adverse impact the COVID-19 pandemic may have on our business; availability of additional capital; uncertainty regarding the results of regulatory submissions and oversight; success of our commercial operations; success of our clinical trials and preclinical studies; risks related to manufacturing, supply and distribution; the risk of litigation or other challenges regarding our intellectual property rights; success of any collaboration or partnership agreements. These and other important risks and uncertainties discussed in our filings with the Securities and Exchange Commission, or SEC, including under the caption “Risk Factors” in our Annual Report on Form 10-K for the year ending December 31, 2019 and subsequent filings with the SEC, could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release.  While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.  These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

Investor Relations Contact:
Elhan Webb, CFA
Email: ewebb@radiuspharm.com
Phone: 617-551-4011

 

FAQ

What is the purpose of the wearABLe phase 3 trial for RDUS?

The trial aims to assess the efficacy and safety of a novel transdermal abaloparatide patch compared to the subcutaneous TYMLOS injection in women with osteoporosis.

When will the results of the wearABLe trial be available?

Top-line data results are expected to be released in Q4 2021.

What are the expected benefits of the abaloparatide patch?

The patch could offer a unique, non-invasive drug delivery method for osteoporosis, enhancing patient compliance and experience.

How many participants were enrolled in the RDUS trial?

Approximately 500 postmenopausal women with osteoporosis were enrolled in the wearABLe phase 3 trial.

What is the current formulation of abaloparatide used for osteoporosis?

The current formulation is TYMLOS, which is administered via subcutaneous injection.