Radius Health (Radius) has announced topline Phase 2 data demonstrating that in women with osteoporosis, BA058, the company’s novel PTHrP (parathyroid hormone-related protein) analog-significantly increased bone mineral density (BMD) at the lumbar spine and femoral neck after six months of therapy.
The gains in lumbar spine and femoral neck BMD were further increased in a subset of patients that elected to continue therapy for a total of 12 months of treatment, and at both time points, the changes were greater than those seen with Forteo (teriparatide), the reference drug used in this dose-finding study.
The objective of the 221-patient Phase 2 clinical trial was to assess safety and evaluate the effect of three doses of BA058 on bone formation markers and on lumbar spine and femoral neck BMD over six months relative to placebo. The study also included a Forteo reference arm.
BA058 was generally safe and well tolerated in this study, with adverse events similar between the BA058 and placebo/Forteo groups. In addition, the occurrence of hypercalcemia was half that of Forteo in the highest dose of BA058 tested. Radius will submit additional detailed results from the Phase 2 study for presentation at an upcoming medical meeting.