Entera Bio Announces Successful EB613 End-of-Phase 2 Meeting with FDA: FDA Agrees to Phase 3 Twelve Month Study with Lumbar Spine BMD (bone mineral density) as the Primary Endpoint

BOSTON and JERUSALEM, Israel, Jan. 04, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ:ENTX), today announced it has concluded its End-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA) on EB613, its oral formulation of human parathyroid hormone (1-34), or PTH, for the treatment of osteoporosis and defined the path for Phase 3 development of EB613, confirming that a fracture study will not be necessary and that lumbar spine BMD at 12 months can be the primary endpoint. The meeting followed completion of its Phase 2 clinical trial, which met its endpoints, including increases in lumbar spine, femoral, neck and hip bone mineral density (BMD) versus placebo after six months of treatment, and demonstrated a safety profile consistent with subcutaneous PTH (1-34) (teriparatide injection) (Forteo^®).