Entera Bio to Present Phase 1 Data from First-in-Class, PTH(1-34) Peptide Tablets (EB612) for the Treatment of Hypoparathyroidism at ENDO 2024

JERUSALEM, May 13, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of orally delivered peptides and small therapeutic proteins, today announced that it has been selected to present data for its investigational program EB612 at the Endocrine Society ENDO 2024 Annual Meeting which will be held on June 1-4, 2024 in Boston, Massachusetts.

The EB612 program is being developed by Entera to provide the first oral PTH(1-34) tablet peptide replacement therapy for patients suffering from hypoparathyroidism. Hypoparathyroidism is characterized by deficient PTH production, hypocalcemia and hyperphosphatemia. Standard treatments include several daily administrations of high dose oral calcium supplements and calcitriol (or analogs), which are often associated with ectopic calcification, including nephrocalcinosis and renal failure. Late stage investigational PTH replacement treatments include TransCon PTH (palopegteriparatide) by Ascendis Pharma A/S and eneboparatide (AZP-3601) by Amolyt Pharma (pending acquisition by AstraZeneca). Both these modalities require patients to administer injections every day. 

The data from this Phase 1 study include PK and early PD results from the application of a new generation of Entera’s N-Tab technology platform with an unmodified PTH(1-34) peptide. One of the objectives of this study was to test the new platform’s ability to reduce the frequency of daily administration of EB612. Entera previously published positive Phase 2a study results in 19 hypoparathyroid patients using a QID regimen (Fraser, JBMR 2021).

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: Day 1
Session: Poster Session P106
Session Date/Time: Saturday, June 1, 2024, 12:15 pm – 1:45 pm 

The abstract can be found on the ENDO 2024 website: https://www.abstractsonline.com/pp8/#!/11016/presentation/9825

About Entera Bio

Entera is a clinical stage company focused on developing oral peptide or protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab) and its pipeline includes five differentiated, first-in-class oral peptide programs, expected to enter the clinic (Phase 1 to Phase 3) by 2025. The Company’s most advanced product candidate, EB613 (oral PTH(1-34)), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis, with no prior fracture. A placebo controlled, dose ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint which is expected to occur by January 2025. The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity; and first oral GLP-2 peptide tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com or follow us on LinkedIn, Twitter, Facebook, Instagram.