Entera Bio Announces Execution of Key Regulatory Milestones for EB613, the First Oral Anabolic Drug Proposed for the Treatment of Osteoporosis; Miranda Toledano Assumes CEO Position

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[{"type":"text","content":"JERUSALEM, July 18, 2022 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of orally delivered peptides and therapeutic proteins, announced today the execution of the following key milestones: The U.S. Food and Drug Administration (FDA) has granted Entera’s request for a Type C Meeting based on the revised phase 3 registrational study for lead clinical asset, EB613 (oral formulation of PTH (1-34, teriparatide), as the first oral anabolic drug to treat post-menopausal women with osteoporosis. The meeting is expected in H2 2022Following its End of Phase 2 Meeting with the FDA, Entera 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 patientsThe 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 studyIn line with her increased executive role since earlier this year, Ms. Miranda Toledano, Entera Board Member and industry veteran with over 20 years of experience succeeds Dr. Spiros Jamas as Chief Executive Officer FDA Acceptance of Type C Meeting: Phase 3 Design of EB613 Under Review During Entera’s End of Phase 2 Meeting, FDA’s Division of Endocrinology remarked on the FNIH BQP published meta-regression analysis which is based on patient-level BMD and fracture incidence data from more than 22 placebo-controlled fracture endpoint studies across all classes of osteoporosis drugs, including teriparatide. The FNIH BQP data indicate that changes in Total Hip BMD (in contrast to lumbar spine or femoral neck BMD measurements) provides a superior surrogate marker of an osteoporosis drug’s effects on vertebral, nonvertebral and all site fracture risk. The FNIH BQP BMD data and Surrogate Threshold Effects (STEs) are in the process of qualification by the FDA to become the first surrogate endpoint for fracture risk reduction1. FDA suggested that Entera explore the FNIH BQP STEs and the design of a placebo-controlled study as an alternative to the originally contemplated non-inferiority design versus Forteo.® Entera has since submitted to the FDA, as part of it...

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