Entera Bio receives FDA agreement that single Phase 3 study could support NDA for EB613

Entera Bio Ltd.

FDA agreed single Phase 3 placebo-controlled trial could support NDA for oral teriparatide EB613 via 505(b)(2) pathway.
Primary endpoint: change in Total Hip BMD at 24 months in post-menopausal osteoporosis patients.
Planned 400 EB613 patients with 2:1 randomization; eligible patients BMD T-score ≤-2.5 to 3.0, no major fracture history.
Company to submit relative PK data comparing oral EB613 to subcutaneous Forteo.
Expects to initiate Phase 3 enrollment in 2023.

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