Press Release Details
Radius Announces Publication of Abaloparatide Phase 3 ATOM Trial Data in the Journal of Bone and Mineral Research
Cambridge, Mass., October 13, 2022 – Radius Health, Inc. (“Radius” or the “Company”), today announced that data from the Phase 3 Abaloparatide for the Treatment of Men with Osteoporosis (ATOM) clinical trial (NCT03512262) evaluating abaloparatide compared to placebo were published in the Journal of Bone and Mineral Research (JBMR). TYMLOS® (abaloparatide) is a human parathyroid hormone-related peptide analog already indicated for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
In the first quarter of 2022, Radius filed a Supplemental New Drug Application (sNDA) with the Food and Drug Administration (FDA) for TYMLOS in men with osteoporosis at high risk for fracture. The sNDA is a 10-month review, with PDUFA date being December 25th, 2022.
Scott Briggs, CEO of Radius, commented, “We are excited to share that data from the successful ATOM study has been published in JBMR. TYMLOS is an excellent molecule, and we remain highly committed to meeting the needs of patients. The filing of the sNDA earlier this year was a key step in potentially expanding TYMLOS’ label to men with osteoporosis and we look forward to the FDA’s decision.”
As reported in the Journal of Bone Mineral Research:
- Men aged 40 to 85 years with osteoporosis were eligible to participate in the study
- Patients were randomized 2:1 to daily subcutaneous injections of abaloparatide 80 mcg or placebo for 12 months
- Primary Endpoint: change from baseline in lumbar spine bone mineral density (BMD)
- Key Secondary Endpoints: BMD change from baseline at the total hip and femoral neck
- A total of 228 men were randomized (abaloparatide, N = 149; placebo, N = 79)
- Baseline characteristics were similar across treatment groups (mean age, 68.3 years; mean lumbar spine BMD T-score, −2.1)
- Abaloparatide significantly increased BMD at 12 months compared with placebo:
- Lumbar spine (8.48% [0.54] vs 1.17% [0.72])
- Total hip (2.14% [0.27] vs 0.01% [0.35])
- Femoral neck (2.98% [0.34] vs 0.15% [0.45])
- The most common treatment emergent adverse events were injection site reaction, dizziness, nasopharyngitis, arthralgia, bronchitis, hypertension, and headache
- During 12 months of abaloparatide treatment, men with osteoporosis exhibited rapid and significant improvements in BMD with a safety profile consistent with previous studies
- Czerwinski, E., Cardona, J., Plebanski, R., Recknor, C., Vokes, T., Saag, K.G., Binkley, N., Lewiecki, E.M., Adachi, J., Knychas, D., Kendler, D., Orwoll, E., Chen, Y., Pearman, L., Li, Y.H. and Mitlak, B. (2022), The Efficacy and Safety of Abaloparatide-SC in Men with Osteoporosis: A Randomized Clinical Trial. J Bone Miner Res. Accepted Author Manuscript. https://doi.org/10.1002/jbmr.4719
Radius is a global biopharmaceutical company focused on addressing unmet medical needs in the areas of bone health 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 and the investigational drug, elacestrant (RAD1901), for potential use in the treatment of hormone-receptor positive breast cancer out-licensed to Menarini Group.
Phone: (617) 583-2017