- Following its End of Phase 2 Meeting with the FDA, Entera Bio Ltd (NASDAQ: ENTX) has designed the pivotal study for EB613 as an 18-month double-blind placebo-controlled study, followed by a 6-month open-label transition to alendronate for all patients.
- The study's primary endpoint employs the Foundation for the National Institutes of Health Bone Quality Program (FNIH BQP) total hip Bone Mineral Density (BMD) as a surrogate endpoint to evaluate fracture risk.
- FDA re-confirmed that with a well-designed BMD study, EB613 approval would not require a fracture study.
- The study will also look at secondary endpoints, including changes in the lumbar spine and femoral neck BMD and EB613's effects on biochemical markers of bone formation and resorption.
- Related: Entera Bio's Formulated Human Parathyroid Hormone Shows Encouraging BMD Data.
- The agency has granted Entera's request for a Type C Meeting based on the revised phase 3 study for the lead clinical asset, EB613, as the first oral anabolic drug to treat postmenopausal women with osteoporosis.
- The meeting is expected in H2 2022.
- Also, Entera appointed Miranda Toledano as CEO as July 15th, 2022, succeeding Spiros Jamas.
- Ms. Toledano has served as Entera's board member since 2018. In May 2022, she also joined as Entera's Chief Business Officer and CFO.
- Price Action: ENTX shares are up 12.9% at $1.58 during the premarket session on the last check Monday
Read at Benzinga