Entera Bio ( NASDAQ: ENTX ) said the U.S. Food and Drug Administration (FDA) agreed that a single Phase 3 placebo-controlled study could support a new drug application seeking approval of EB613 to treat post-menopausal women with osteoporosis.
In the meeting , the FDA also agreed that change in Total Hip Bone Mineral Density (BMD) could serve as the main goal of the 2-year study of EB613 [oral formulation of PTH (1-34, teriparatide)], which is expected to enroll 400 patients in total, the company said in an Oct. 6 press release.
Entera added that FDA agreed to the 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. This patient population was similar with that studied during the company phase 2, 6-month dose ranging study which met all main and secondary goals.
The company intends to submit relative PK data comparing its oral tablet form of teriparatide, EB613 versus the subcutaneous injection of teriparatide, Forteo, sold by Eli Lilly ( NYSE: LLY ), to support the 505(b)(2) pathway.
ENTX -1.82% to $1.08 premarket Oct. 6
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FDA agrees to single phase 3 trial by Entera for bone disorder drug EB613 to support approval