Entera Bio Phase 2 Data Supporting EB613’s (Oral PTH(1-34)) Anabolic Effect on Postmenopausal Women with Osteoporosis at High Risk for Fracture Selected for Plenary Poster Session Presentation at the ASBMR 2026 Annual Meeting
Rhea-AI Summary
Entera Bio (NASDAQ: ENTX) announced that post-hoc data from its Phase 2 trial of EB613, an oral PTH(1-34) tablet being developed as the first oral anabolic osteoporosis treatment, has been selected for a Plenary Poster Presentation and a second poster at the ASBMR 2026 Annual Meeting in Boston, October 9–12, 2026.
The sensitivity analysis evaluates EB613’s anabolic effects on bone mineral density and bone turnover markers at 6 months in postmenopausal women with osteoporosis at high fracture risk. According to Entera, the 161-patient, 6‑month, placebo-controlled Phase 2 study met biomarker and BMD endpoints without significant safety concerns, showing dose‑proportional increases in bone formation markers and increases in lumbar spine, total hip, and femoral neck BMD. Entera plans a single randomized, double‑blind, placebo‑controlled Phase 3 trial in approximately 750 postmenopausal women with osteoporosis to support a potential NDA submission for EB613.
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Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 22 | FDA Phase 3 feedback | Positive | +22.3% | FDA accepted a single 750-patient registrational Phase 3 protocol for EB613 |
| Jun 15 | Phase 1 comparative data | Positive | -1.6% | Single-tablet EB613 showed comparable PK/PD, calcemic effects, and safety |
| Mar 04 | Phase 3 protocol submission | Positive | -3.0% | Entera submitted the streamlined EB613 Phase 3 protocol to the FDA |
| Oct 23 | Phase 2 BMD data | Positive | -7.0% | Post-hoc analysis reported significant BMD gains at six months |
| Aug 28 | Clinical data presentations | Positive | -1.0% | Entera announced upcoming presentations across three oral peptide programs |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Matched clinical-trial events showed one aligned and four divergent reactions, with an average move of 1.94%.
Key Terms
post-hoc technical
pTH(1-34) medical
bone mineral density medical
bone turnover markers medical
3d-dxa medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
TEL AVIV, Aug. 04, 2026 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (“Entera” or the “Company”), a leader in the development of oral peptides, today announced that post-hoc data from its Phase 2 clinical trial of EB613 (oral PTH(1-34) tablet) has been selected for two presentations including the Plenary Poster Presentation 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. Plenary Posters are highly ranked poster presentations selected by the ASBMR program committee to be presented at the Welcome Reception and Plenary Poster Session of the ASBMR 2026 Annual Meeting.
EB613 is being developed as the first oral anabolic (bone forming) tablet treatment for osteoporosis. The Phase 2 study (Tripto-Shkolnik 2024) randomized 161 postmenopausal women with low bone mass or osteoporosis to placebo or four EB613 dose levels for 6 months. Entera is planning to conduct a single, randomized, double-blind, placebo-controlled, Phase 3 trial of EB613 in approximately 750 postmenopausal women with osteoporosis to support a potential New Drug Application (NDA) submission for EB613 for the treatment of women with postmenopausal osteoporosis. To explore the anabolic effect of EB613 in postmenopausal women with osteoporosis (baseline T-score of ≤-2.5), a post-hoc sensitivity analysis evaluating the relationship between baseline T-score severity and EB613 effects on Bone Mineral Density (BMD) and Bone Turnover Markers (BTM) at 6 months was conducted.
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 Osteoporosis
Osteoporosis is a chronic, progressive disorder in which bone resorption exceeds formation, resulting in decreased bone strength and increased susceptibility to fracture. Osteoporosis is a major and growing public health issue, responsible for over 2 million fractures annually in the US. After age 50, one in three women and one in five men will suffer an osteoporosis-related fracture in their remaining lifetime. Osteoporotic fractures lead to chronic pain, decreased quality of life, and increased disability, and contribute to premature death. Studies show that up to 20
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:
IR@enterabio.com
