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Entera Bio Announces FDA’s Acceptance of a Type D Meeting Review to Affirm Design of the Pivotal, Phase 3 Protocol for EB613 PTH Mini Tablets, as the First Oral Osteoanabolic Treatment of Post-Menopausal Osteoporosis
Type D meeting protocol submission builds on concurrence reached with FDA following successful Type C meeting and supports potential Phase 3 initiation in H2
About this update from Entera Bio Ltd.
[{"type":"text","content":"Type D meeting protocol submission builds on concurrence reached with FDA following successful Type C meeting and supports potential Phase 3 initiation in H2 2023 JERUSALEM, Feb. 15, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and therapeutic proteins, today announced that a Type D meeting protocol review has been accepted by the U.S. Food and Drug Administration (FDA) to provide responses by March 30th, 2023. The pivotal, Phase 3 study protocol is entitled “A 24-Month Phase 3, Randomized, Double-Blind, Global Multicenter Study Comparing the Effects of Oral hPTH(1-34) (EBP05[EB613]) Daily Tablets vs. Placebo on Bone Mineral Density (BMD) in Postmenopausal Women with Osteoporosis.” EB613 is the first oral, once daily mini tablet presentation of hPTH (1-34), (teriparatide). EB613 has a well-established mechanism of action, PK and safety profile and met primary (PD/biomarker) and secondary endpoints (BMD) in a placebo controlled, dose ranging Phase 2 study in 161 postmenopausal women with low bone mass and osteoporosis. As part of its briefing documents for the Type D process, Entera has submitted its Phase 3 protocol which reflects (1) the agreement reached during the Company’s September 2022 Type C Meeting discussion with FDA that a single 24 month Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission under the 505(b)(2) regulatory pathway and (2) that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study. The objective of Type D meeting review is to confirm that the protocol fully meets FDA’s expectations, including the analysis of the primary endpoint and the population PK evaluations, ahead of potential study initiation in H2 2023. The FDA previously agreed on major design elements of the protocol including the primary endpoint, enrollment criteria, titration and 2:1 randomization plan, and that 400 or more patients on EB613 is consistent with ICH E1A to support safety for the NDA. The current protocol reflects a 667/333 patient randomization, a 24 month total study duration and a futility interim analysis to occur when the last of the 300 first randomized subjects have completed 12 months in the study. Furthermore, Entera has provided power calculati...