Positive topline results were announced from a phase 3 study evaluating the efficacy and safety of abaloparatide in men with osteoporosis.
The randomized, double-blind, placebo-controlled ATOM study (ClinicalTrials.gov Identifier: NCT03512262) included 228 male patients with osteoporosis. Patients were randomly assigned 2:1 to receive abaloparatide, a human parathyroid hormone related peptide analogue, or placebo administered subcutaneously once daily. The primary endpoint was the percent change in lumbar spine bone mineral density (BMD) at 12 months from baseline.
Results showed that patients treated with abaloparatide experienced a statistically significant average increase in lumbar spine BMD of 8.5% at 12 months compared with 1.2% for those who received placebo (P <.0001). Significant changes with abaloparatide were also observed in lumbar spine BMD at 6 months, total hip BMD at 12 months, and femoral neck BMD at 12 months (all key secondary endpoints). The safety profile of abaloparatide was consistent with results in previously reported studies.
“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,” said Bruce Mitlak MD, the Chief Medical Officer of Radius.
Full study data will be presented at a future medical meeting. Radius plans to submit a supplemental New Drug Application in the first quarter of 2022.
Abaloparatide is currently marketed under the brand name Tymlos® for the treatment of postmenopausal women with osteoporosis at high risk for fracture.
Radius announces positive phase 3 topline results for Tymlos® (abaloparatide) subcutaneous injection in males with osteoporosis. News release. Radius Health Inc. Accessed October 18, 2021. https://www.globenewswire.com/news-release/2021/10/18/2315688/31149/en/Radius-Announces-Positive-Phase-3-Topline-Results-for-TYMLOS-abaloparatide-Subcutaneous-Injection-in-Males-with-Osteoporosis.html.