Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022

About this update from Entera Bio Ltd.

[{"type":"text","content":"JERUSALEM, Nov. 10, 2022 (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 its financial results for the third quarter of 2022 and provided the following corporate updates. Corporate Updates: Achieved FDA Agreement for Pivotal Study of EB613, the World’s First Daily Bone Forming Oral PTH Tablet On October 6th, 2022, Entera announced that it had successfully completed its Type C meeting and reached a record agreement with the U.S. Food and Drug Administration (FDA) that a single pivotal Phase 3 placebo-controlled study could support a New Drug Application (NDA) submission for its lead clinical candidate, EB613 under the 505(b)(2) regulatory pathway.Importantly, the FDA also agreed that total hip bone mineral density (BMD), not fracture, could serve as the primary endpoint for the registrational study of EB613; and that Entera could enroll the same post-menopausal osteoporosis patient population that significantly benefited from EB613 treatment during Entera’s Phase 2 clinical study which was reported in 2021.EB613 is the first oral, daily tablet formulation of synthetic hPTH (1-34), (teriparatide), consisting of the exact same 34 amino acid sequence as daily subcutaneous teriparatide injection, Forteo® which has been the leading anabolic treatment of osteoporosis since 2002 with peak sales of $1.7 billion in 2018 prior to patent expiration. EB613 tablets are simple, small (~ 6 mm wide) and administered once daily.Low BMD osteoporotic patients at high risk of fracture are often reluctant to initiate injectable anabolic (bone forming) therapy and represent an estimated 40% of the 3 million currently treated patients across the United States, while current bone forming injections treat less than 10% of these patients1. As the first daily tablet PTH osteoanabolic treatment, EB613 could significantly impact the osteoporosis treatment paradigm. Patient enrollment in the pivotal phase 3 study is expected to commence in 2023. New Phase 2 Data Presented at the ASBMR Annual Meeting Demonstrate Statistically Significant Correlation of EB613’s Dose Proportional Oral Absorption and Clinical Benefit New findings on EB613 were presented in a poster titled “A Six-month Phase 2 Study of Oral PTH (EBP05) in Postmenopausa...

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