Entera Bio to Present Phase 1 Data on PTH(1-34) Tablets for Hypoparathyroidism at ENDO 2024
JERUSALEM, May 13, 2024-- Entera Bio Ltd. (NASDAQ: ENTX), a pioneering company in the field of orally administered peptides and therapeutic proteins, has announced its selection to present data for its investigational program EB612 at the Endocrine Society ENDO 2024 Annual Meeting. This event is scheduled to take place from June 1-4, 2024, in Boston, Massachusetts.
The primary focus of the EB612 program is to develop the first oral PTH(1-34) tablet therapy for patients with hypoparathyroidism. This condition is marked by insufficient production of parathyroid hormone (PTH), leading to low calcium levels (hypocalcemia) and high phosphate levels (hyperphosphatemia). Traditional treatments typically involve multiple daily doses of high-calcium supplements and calcitriol, which can result in complications such as ectopic calcification, nephrocalcinosis, and renal failure. Currently, late-stage investigational PTH replacement treatments like TransCon PTH by Ascendis Pharma and eneboparatide by Amolyt Pharma require daily injections.
Data from the Phase 1 study of EB612 includes pharmacokinetic (PK) and early pharmacodynamic (PD) results using Entera’s advanced N-Tab™ technology platform with an unmodified PTH(1-34) peptide. One goal of this study was to evaluate the potential of the new platform to decrease the frequency of daily administration. Previous positive results from a Phase 2a study involving 19 patients with hypoparathyroidism were published, indicating efficacy with a QID regimen.
The results of the Phase 1 study will be presented under the following details:
- Abstract Title: Phase 1 Study Results Of EB612, A First-in-Class Oral PTH(1-34) Analog For The Treatment Of Hypoparathyroidism
- Presentation Number: SAT-758
- Presentation Type: Late-Breaking Poster Presentations
- Session: Poster Session P106
- Session Date/Time: Saturday, June 1, 2024, from 12:15 pm to 1:45 pm
Entera Bio Ltd. is committed to developing oral peptide and protein replacement therapies to address significant unmet medical needs. The company utilizes a proprietary technology platform, N-Tab™, and has a pipeline of five unique, first-in-class oral peptide programs expected to advance from Phase 1 to Phase 3 clinical trials by 2025.
Entera's most advanced product candidate, EB613 (oral PTH(1-34)), is in development as the first oral, osteoanabolic (bone-building) once-daily tablet treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis. A Phase 2 study of EB613 met its primary and secondary endpoints, and the company is preparing for a Phase 3 registrational study, expected to start by January 2025, following the FDA's qualification of a quantitative BMD endpoint.
Additionally, Entera is developing the first oral versions of other therapeutic peptides, including an oral oxyntomodulin for obesity treatment and an oral GLP-2 peptide for rare malabsorption conditions like short bowel syndrome, in collaboration with OPKO Health.
Entera Bio Ltd. continues to leverage its innovative technology platform to transform the standard of care in various therapeutic areas, aiming to provide patients with more convenient and effective treatment options.
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