‒ Phase 2 EB613 Clinical Trial in Osteoporosis Achieves 6-month Bone Mineral Density Endpoint; Primary and Key Secondary Endpoints Met ‒
‒ Preparing for End of Phase 2 Meeting with FDA for Planned Pivotal One-year Phase 3 Study Comparing Changes in Lumbar Spine BMD in Patients Treated with EB613 Versus Treatment with Forteo®, as per a 505(b)(2) Pathway ‒
‒ Company to Host Conference Call and Webcast Today at 8:30 a.m. ET ‒
BOSTON and JERUSALEM, Aug. 16, 2021 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered large molecule therapeutics, today announced financial and operating results for the quarter ended June 30, 2021.
Second Quarter 2021 and Recent Highlights
- 6-Month Bone Mineral Density (BMD) Results Show Dose-Related Efficacy: Final topline results from Entera’s Phase 2 clinical trial of EB613, an oral formulation of human parathyroid hormone (1-34) or PTH positioned to be the first oral bone building (anabolic) product to treat osteoporosis patients, achieved its primary and key secondary endpoints. The most important BMD endpoint — change in lumbar spine BMD after 6 months — was met in the double-blind, dose-ranging, placebo-controlled study in 161 postmenopausal female subjects with osteoporosis or with low BMD. Subjects receiving 2.5 mg of EB613 showed significant dose-related increases in BMD at the lumbar spine, total hip, and femoral neck at 6 months with a placebo adjusted increase of 3.78% in lumbar spine BMD (p