Radius Announces Positive Phase 3 Topline Results for TYMLOS® (abaloparatide) Subcutaneous Injection in Males with Osteoporosis
- Category: Proteins and Peptides
- Published on Monday, 18 October 2021 17:29
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- 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
BOSTON, MA, USA I October 18, 2021 I Radius Health, Inc. (“Radius” or the “Company”) (NASDAQ: RDUS), today announced positive topline results from the ATOM study evaluating abaloparatide 80mcg subcutaneous (SC) for use in males with osteoporosis.
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.
Chhaya Shah, Senior Vice President, who leads the clinical and regulatory activities for abaloparatide, commented, “The team did a phenomenal job working through all of the complexities encountered as a result of the Covid-19 virus, in completing the study and delivering positive results.” Shah added further, “We remain on track for an sNDA submission in the first quarter of 2022.”
Bruce Mitlak MD, the Chief Medical Officer of Radius, added, “Osteoporosis in men is underdiagnosed and therefore, often undertreated. The study results are highly encouraging as they demonstrated a significant effect of abaloparatide in increasing lumbar spine BMD as well as the key secondary endpoint of hip BMD and are an important step towards making abaloparatide available for treating men with osteoporosis.”
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 U.S. Food and Drug Administration for the treatment of postmenopausal women with osteoporosis at high risk for fracture. The Radius clinical pipeline includes investigational abaloparatide injection for potential use in the treatment of men with osteoporosis; an investigational abaloparatide transdermal system for potential use in the treatment of postmenopausal women with osteoporosis; the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group; and the investigational drug RAD011, a synthetic cannabidiol oral solution with potential utilization in multiple endocrine and metabolic orphan diseases, initially targeting Prader-Willi syndrome.
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 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.
SOURCE: Radius Health