Entera Bio Ltd. presented 2 posters at the Annual Society of Bone and Mineral Research (ASBMR) 2023 Annual Meeting held on October 13-16, 2023 in Vancouver, BC, Canada. The lead drug candidate of Entera?s EBP05 formulation, EB613 is currently being developed as the first once-daily oral anabolic therapy for the treatment of osteoporosis. In a 6-month,161-patient, placebo-controlled Phase 2 study, EB613 produced rapid dose-proportional changes in biochemical markers and increased Bone Mineral Density (BMD) in postmenopausal women with low BMD osteoporosis.

Abstract Title: First Oral PTH(1-34) Tablet Treatment for Osteoporosis Demonstrates Rapid Pharmacodynamic Effect on Plasma Levels of Endogenous PTH(1-84). A Phase 1 study comparing oral EB613, subcutaneous (SC) hPTH(1-34) 20 g (Forteo®) and a new generation of Entera?s oral peptide delivery platform is ongoing. One of the first objectives of this study is to rapidly evaluate the pharmacodynamic (PD) effects of Entera?s oral PTH(1-34) tablets.

This analysis relates to Entera?s lead formulation. Additional data on new formulations will be released later in 2023. An increase in plasma ionized calcium should result in decreased secretion and plasma concentrations of endogenous PTH(1-84).

Thus, a reduction in plasma PTH(1-84) should provide an early indication of the systemicexposure and pharmacologic activity of Entera?s oral PTH(1-34) tablets. In the study, the mean percentage of endogenous plasma PTH (1-84) 120 minutes after dosing was 59.2%, 54.3%, and 52.3% for EB613 1.5 mg, 2.5 mg and Forteo®, respectively; and showed consistent effects across other early PD markers such as serum calcium, phosphorus, and 1,25-dihydroxyvitamin D. Abstract Title:  Pharmacokinetic (PK) Profile of EBP05/EB613 Oral Teriparatide Tablets in Women of Post Menopausal Age Versus Young Adult Men. This retrospective analysis compares the pharmacokinetic profile of EBP05 in healthy young males versus female patients of menopausal age with hypoparathyroidism.

A single administration of the same dose, 2.25 mg oral PTH (1-34), in healthy young men (22 years, range 21-26) and women of postmenopausal age (62 years, range 49 -63) resulted in a median Cmax of 425 pg/ml vs 521 pg/ml, and a median AUC of 157 pg*hour/ml vs 158 pg*hour/ml respectively.