Business
Entera Bio Announces Q2 2023 Financial Results and Corporate Updates
JERUSALEM, Aug. 11, 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, Aug. 11, 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 reported corporate updates and financial results for the second quarter ended June 30, 2023. “In the last year, we have successfully focused our resources to drive value across three main pillars: (1) moving our EB613 program along the right path to a Phase 3 registrational study, (2) developing a potential new generation for EB612 and (3) expanding our technological capabilities and platform. Our 2022 R&D plan resulted in pre-clinical validation of proprietary new generations of our oral peptide delivery platform. These are primarily designed to modify pharmacokinetic (PK)/ pharmacodynamic (PD) parameters, optimize bioavailability and curb oral dosing regimens across more complex peptides and therapeutic proteins. They are also designed to develop novel, proprietary life cycle extension candidates for our own first-in-class PTH(1-34) mini tablet treatments for osteoporosis and hypoparathyroidism. We view this as crucial given current pharmacoeconomic debates across our industry. We are determined to develop a simple, oral mini tablet format of peptides and therapeutic proteins in the most efficient manner to facilitate access to millions of patients globally. We expect to announce data from our Phase 1B study of our new generation platform in the second half of 2023. Likewise, we anticipate critical updates related to the FNIH-BQP qualification process, which has a direct implication to the potential initiation of our pivotal Phase 3 program for EB613,” said Miranda Toledano, Entera’s Chief Executive Officer. Corporate Updates: EB613: The First and Only Once Daily PTH(1-34) Mini Tablet Treatment for Post-Menopausal Women with High Risk Osteoporosis. Alignment continues across our CMC/supply chain, clinical operations, and strategic discussions to potentially initiate the Phase 3 registrational study for EB613. A critical milestone is anticipated with FDA’s review and potential qualification of the FNIH-ASBMR SABRE BQP.1EB612: Next Generation Oral Peptide Platform Data Read-Outs Expected in H2’2023. In May 2023, Entera initiated a 45 subject, three cohort, Phase 1B study comparing the safety, PK and early PD outcomes for several novel PTH...