Press Release Details
Radius Announces Positive Phase 3 Topline Results for TYMLOS® (abaloparatide) Subcutaneous Injection in Males with Osteoporosis
- ATOM study met the primary endpoint of change in lumbar spine bone mineral density at 12 months (p-value < 0.0001)
- Study also met secondary endpoints relating to bone mineral density changes in lumbar spine at 6 months as well as at hip and femoral neck at 12 months
- Safety profile was consistent with results in previously reported trials with abaloparatide
- Plan to submit supplemental new drug application (sNDA) in Q1, 2022
The ATOM study met its primary endpoint – the percentage change in lumbar spine (LS) bone mineral density (BMD) compared to placebo – demonstrating statistical significance after 12 months (p-value < 0.0001). Study participants receiving abaloparatide-SC experienced an average increase in LS BMD of 8.5% compared to patients receiving the placebo experiencing an average increase of 1.2%.
The study also met secondary endpoints, which measured the percentage change compared to placebo for lumbar spine BMD at 6 months, total hip BMD at 12 months, and femoral neck BMD at 12 months.
The safety profile of abaloparatide in the ATOM study was consistent with results in previously reported trials.
The Company will complete a full evaluation of the ATOM data and work with investigators to present detailed results at a future medical meeting.
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health, orphan diseases, and oncology. Radius’ lead product, TYMLOS® (abaloparatide) injection, was approved by the
About TYMLOS (abaloparatide) injection
TYMLOS (abaloparatide) injection was approved by the
About ATOM Phase 3 Study
The ATOM Phase 3 study is a randomized, double-blind, placebo-controlled study to assess efficacy and safety of abaloparatide injection in 228 men with osteoporosis. The primary endpoint is change in lumbar spine BMD at 12 months compared with placebo, and it is expected to form the basis of a supplemental NDA seeking to expand the use of TYMLOS to treat men with osteoporosis at high risk for fracture. More information can be found on www.clinicaltrials.gov, NCT03512262.
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, including without limitation statements regarding the expected timing of our sNDA submission based on the ATOM Phase 3 study results.
These forward-looking statements are based on management's current expectations. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: the adverse impact the ongoing COVID-19 pandemic is having and is expected to continue to have on our business, financial condition and results of operations, including our commercial operations and sales, clinical trials, preclinical studies, and employees; quarterly fluctuation in our financial results; our dependence on the success of TYMLOS, and our inability to ensure that TYMLOS will obtain regulatory approval outside the
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Source: Radius Health Inc.