Press Releases May 28, 2026 08:50 AM

Entera’s EB613, First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis - Single Tablet Data Selected for Late Breaking Oral Presentation at ENDO 2026 Annual Meeting; Additional Oral Peptide Pipeline Data Accepted for Presentation

Entera Bio’s EB613 Oral Osteoporosis Treatment Data Selected for Late Breaking Presentation at ENDO 2026

By Ajmal Hussain ENTX

Entera Bio Ltd., a clinical-stage biotech company focused on oral peptide therapies, announced that multiple abstracts on its oral peptide pipeline, including the first oral anabolic osteoporosis treatment EB613, were accepted for presentation at ENDO 2026. The clinical data for EB613, the company's leading candidate for a Phase 3 osteoporosis study, will be featured in a Late Breaking Oral Presentation, highlighting positive Phase 2 results. Additional pipeline updates include oral therapies for hypoparathyroidism, obesity, metabolic disorders, and rare malabsorption conditions. This recognition validates Entera’s innovative oral peptide platform and advances its path toward regulatory milestones and potential market launches.

Entera’s EB613, First-in-Class Oral PTH(1-34) Anabolic for Osteoporosis - Single Tablet Data Selected for Late Breaking Oral Presentation at ENDO 2026 Annual Meeting; Additional Oral Peptide Pipeline Data Accepted for Presentation
ENTX

Key Points

  • EB613, an oral PTH(1-34) anabolic tablet for osteoporosis, showed positive Phase 2 results meeting primary and secondary endpoints.
  • EB613 clinical data selected for Late Breaking Oral Presentation at a major endocrinology conference, ENDO 2026, boosting visibility and credibility.
  • The company has a robust pipeline with oral therapies targeting hypoparathyroidism, obesity/metabolic disorders, and rare malabsorption diseases, leveraging a proprietary technology platform (N-Tab®).
  • Impacted sectors include biotechnology, pharmaceutical development, healthcare, especially osteoporosis and metabolic disease treatment markets.

TEL AVIV, May 28, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that multiple abstracts across its oral peptide pipeline have been accepted for presentation at ENDO 2026, the annual meeting of the Endocrine Society, taking place June 13-16, 2026 in Chicago, Illinois, USA. Notably, new clinical data supporting Entera’s single EB613 tablet as the final candidate for its planned Phase 3 study in postmenopausal women with osteoporosis was selected for a Late Breaking Oral Presentation.

Abstract Title: Transforming Anabolic Treatments for Osteoporosis: New Clinical Data Supports a Single EB613 Tablet [Oral PTH(1-34)] as the Final Candidate for a Phase 3 Study
Session Title: Late-Breaking Oral Abstract/Rapid-Fire II
Session Date/Time: Sunday, June 14, 2026, 3:30 – 4:15 PM CT

Abstract Title: Pre-Clinical Results for EB612: First-in-Class Oral Long-Acting PTH(1-34) Analog as Hormone Replacement Tablet for Patients with Hypoparathyroidism
Session Date/Time: Monday, June 15, 2026, 12:00 – 1:30 PM CT

Abstract Title: EB618, First-in-Class Oral Tablet of Dual GLP-1/Glucagon Receptor Agonist for Patients with Obesity and Metabolic Disorders: Results from PK-PD Study in Non-Human Primates
Session Date/Time: Saturday, June 13, 2026, 12:15 – 1:45 PM CT

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.

Cautionary Statement Regarding Forward Looking Statements
Various statements in this press release are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this press release regarding our prospects, plans, financial position, business strategy, clinical development activities, collaboration arrangements and expected financial and operational results are forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved. Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this press release. The information in this press release is provided only as of the date of this press release, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.

Company Contact:
[email protected]


Risks

  • Clinical development risks including potential setbacks in Phase 3 trials based on Phase 2 data and regulatory reviews by FDA.
  • Manufacturing and supply chain disruptions could delay product development and commercialization timelines.
  • Competition from other osteoporosis and metabolic disorder treatments, including injectable and emerging oral therapies, may impact market adoption and revenue potential.

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