Entera Bio Inks Deal With FDA For Single Phase 3 Trial To Support NDA For EB613 For Osteoporosis

(RTTNews) - Entera Bio Ltd. (ENTX), a developer orally delivered peptides and therapeutic proteins, announced Thursday the successful conclusion of its Type C meeting and agreement from the U.S. Food and Drug Administration (FDA) that a single Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission of EB613 (oral hPTH (1-34), teriparatide tablets) under the 505(b)(2) regulatory pathway.

The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post-menopausal osteoporosis patients.

The single pivotal Phase 3 clinical trial includes a 24-month placebo-controlled duration with change in Total Hip BMD assessed as the primary endpoint. The 2:1 randomization (EB613 vs. placebo) and planned 400 patients exposed to EB613 are expected to be sufficient to support both the safety and efficacy assessments for the NDA.

Furthermore, the FDA agreed with Entera's proposed enrollment of post-menopausal women with osteoporosis based on a BMD T-score of =-2.5 to -3.0 and no major fracture history.

Finally, Entera intends to submit relative PK data comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo to support the 505(b)(2) pathway.