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Entera Bio Provides 2022 Corporate Milestones and Financial Results for the Year Ended December 31, 2022
JERUSALEM, March 31, 2023 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered
About this update from Entera Bio Ltd.
[{"type":"text","content":"JERUSALEM, March 31, 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 a summary of 2022 corporate achievements and financial results for the year ended December 31, 2022. “The year 2022 and 2023 year to date, has been a critical time for Entera, during which focus, optimization and execution across our organization has been paramount to adequately prepare our EB613 program to become phase 3 ready, from a clinical, regulatory, and manufacturing standpoint. EB613 (oral PTH(1-34), teriparatide) is positioned as the first potential daily tablet anabolic therapy for the treatment of post-menopausal women with low Bone Mineral Density (BMD) and osteoporosis. In addition, we have continued to harness our scientific capabilities and intellectual property to expand our proprietary platform with novel drug candidates, including a new generation for EB612, potentially the first PTH (1-34) peptide replacement therapy in tablet form for the treatment of hypoparathyroidism,” stated Miranda Toledano, Chief Executive Officer of Entera. A brief review of key EB613 related milestones: In June 2021, Entera reported positive results from its double-blind, placebo-controlled Phase 2 study of EB613 in 161 post-menopausal women with low BMD and osteoporosis. The study met all PD/ biomarker, BMD endpoints, and demonstrated a generally well tolerated safety profile. It was also noted that EB613 had a differentiated biomarker and BMD profile versus historical 6-month data reported with daily subcutaneous injections of Forteo® in a similar population.In January 2022, Entera received FDA’s End of Phase 2 meeting minutes which conveyed concern with the previously proposed Phase 3 study, based on a 12-month non-inferiority head-to-head design versus Forteo® and whether such a trial would be successful.In response to the FDA’s End of Phase 2 minutes, Entera re-designed the proposed phase 3 to potentially align with FDA’s suggestion to explore a placebo-controlled phase 3 design with a Total Hip BMD (TH BMD) endpoint, given emerging seminal publications from the FNIH BQP-ASBMR project.On July 18th, 2022, Entera announced that the FDA had granted Entera’s request for a Type C Meeting based on the revised phase 3 registrational p...