Entera Bio announces FDA acceptance of Type D meeting review for EB613 PTH

Entera Bio announced that a Type D meeting protocol review has been accepted by the U.S. 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 Daily Tablets vs. Placebo on Bone Mineral Density in Postmenopausal Women with Osteoporosis." EB613 is the first oral, once daily mini tablet presentation of hPTH. EB613 met primary and secondary endpoints 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 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 submission under the 505(b)(2) regulatory pathway and (2) that Total Hip Bone Mineral Density 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.