| 2023-11-29 |
Entera Bio Ltd. |
Results Interim Results from Ongoing Clinical Study Confirm EB613 Optimized Profile for Osteoporosis Treatment and Potential for Entera’s Next Generation Oral Peptide Platform enterabio.com ↗
EBP05 induced a rapid and dose-proportional increase in plasma drug concentrations of PTH(1-34) at all doses tested. |
| 2023-10-16 |
Entera Bio Ltd. |
Results Entera Bio Reports Rapid Pharmacodynamic (PD) Response and Consistent Pharmacokinetic (PK) Data for its First-in-Class Oral PTH(1-34) Mini Tablets at the ASBMR 2023 Annual Meeting enterabio.com ↗
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| 2023-02-15 |
Entera Bio Ltd. |
Regulatory 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 enterabio.com ↗
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| 2022-11-10 |
Entera Bio Ltd. |
Results Entera Bio Provides Corporate Updates and Financial Results for the Third Quarter of 2022 enterabio.com ↗
New analyses of hPTH concentration in blood shortly after a dose of EB613 tablets confirmed a strong, statistically significant correlation between mean blood level and the dose of EB613 taken. |
| 2022-10-06 |
Entera Bio Ltd. |
Regulatory Entera Bio Announces FDA Agreement for a Single Phase 3 Clinical Trial to Support an NDA for EB613 for the Treatment of Osteoporosis enterabio.com ↗
The FDA also agreed that Total Hip Bone Mineral Density (BMD) could serve as the primary endpoint for the registrational study of EB613 in post-menopausal osteoporosis patients. |
| 2022-09-12 |
Entera Bio Ltd. |
Results Entera Bio Presents Dose Proportional Absorption and Correlation to BMD Clinical Response Data from its Phase 2 Study of EB613 in Post-Menopausal Osteoporosis Patients at the ASBMR 2022 Annual Meeting enterabio.com ↗
These new analyses of blood hPTH concentration shortly after a dose of oral EB613 tablets confirm a strong, statistically significant correlation between mean blood level and the dose of EB613 taken. |