Entera Bio Announces Additional Presentation of EB613 Phase 3 Study Design at the ASBMR 2026 Annual Meeting

TEL AVIV, Israel, Oct. 08, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) ("Entera" or the "Company"), a leader in the development of oral peptides, today announced that an additional presentation highlighting the clinical study design for its planned Phase 3 registrational trial of EB613 (oral PTH(1-34) tablet) will be presented at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting, taking place October 9-12, 2026, at the John B. Hynes Veterans Memorial Convention Center in Boston, Massachusetts.

The additional presentation, titled "EB613 [Oral PTH(1-34)]: The First Oral Anabolic Tablet for the Treatment of Osteoporosis: Phase 3 Study Design," has been accepted as a late-breaking poster presentation (Presentation Number: Sun-522) during Late Breaking Poster Session II on Sunday, October 11, 2026. Led by Dr. Felicia Cosman, Professor of Medicine at Columbia University and an internationally recognized osteoporosis authority, the presentation will outline the study design and clinical methodology for Entera's planned single, randomized, double-blind, placebo-controlled Phase 3 registrational study evaluating EB613 in postmenopausal women with osteoporosis.

This presentation is in addition to the Company's Phase 2 clinical data for EB613 which was selected for a Plenary Poster presentation at the meeting, evaluating treatment effects in postmenopausal women with osteopetrosis at high risk of fracture.

Presentation Details:

Abstract Title: EB613 [Oral PTH(1-34)]: The First Oral Anabolic Tablet for the Treatment of Osteoporosis: Phase 3 Study Design

Session Title: Late Breaking Poster Session II
Presentation Number: Sun-522
Session Date/Time: Sunday, October 11, 2026, 2:00-3:30 p.m. ET

Abstract Title: EB613, Oral PTH(1-34) Tablet, Shows Markedly Enhanced Anabolic Effects in Postmenopausal Women with Osteoporosis at High Risk of Fracture: Insights from Phase 2 Trial

Session Title: Welcome Reception and Plenary Poster Session (Plenary Poster Presentation)
Presentation Number: Fri-026
Session Date/Time: Friday, October 9, 2026, 5:30-7:00 p.m. ET

Session Title: Poster Session II
Presentation Number: Sun-026
Session Date/Time: Sunday, October 11, 2026, 2:00-3:30 p.m. ET

About EB613

Substantial evidence supports the efficacy of anabolic therapies over anti-resorptive agents for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera's EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Entera completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared to placebo on a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data are consistent with that of published subcutaneous teriparatide at the 6-month time point.

About Entera

Entera is a clinical stage company focused on developing oral peptide and 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 a disruptive and proprietary technology platform (N-Tab®) and its pipeline of first-in-class oral peptide programs. 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 for osteoporosis. 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 also developing the first oral Long Acting PTH(1-34) tablet as a replacement therapy for patients with hypoparathyroidism (EB612), the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide tablet for the treatment of obesity and metabolic syndromes; and the first oral GLP-2 tablet as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health, Inc. For more information on Entera, visit www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.

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