Entera Bio to Present New Clinical Data from Phase 2 Trial of EB613 at the 2025 North American Menopause Society (NAMS) Annual Meeting

Rhea-AI Summary

Entera Bio (NASDAQ: ENTX) will present new Phase 2 clinical data for EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting in Orlando, Oct 21–25, 2025.

The poster (P-66) reports six-month bone mineral density (BMD) outcomes in early postmenopausal women with low bone mass or osteoporosis, evaluating oral PTH[1-34] tablets as a potential anabolic option earlier in treatment where injectables are underutilized. Presentation is a poster session on Oct 23, 2025, 6:15–7:15 PM in Windemere Exhibit Hall.

Insights

Clinical development strategist

Phase 2 poster shows six‑month BMD gains for an oral anabolic candidate; early data may shift treatment timing if confirmed.

Entera Bio will present Phase 2 results for EB613 at the North American Menopause Society meeting on October 23, 2025, with a poster (P-66) reporting increases in bone mineral density over a six‑month period in early postmenopausal women with low bone mass or osteoporosis. The presentation explicitly examines using an oral parathyroid hormone fragment (PTH[1-34]) earlier in the care pathway where injectable anabolics are underused.

The core business mechanism is clear: an oral anabolic tablet that increases BMD could broaden access compared with injectable options and enable earlier intervention. Key dependencies include confirmation of these effects in larger, longer trials and regulatory review; acceptance will also depend on safety, durability of effect beyond six months, and clinician uptake. Watch the poster on October 23, 2025 and subsequent full data releases or trial readouts for longer follow‑up and safety details within the next 6–24 months.

First-time presentation examining bone outcomes in early postmenopausal women

JERUSALEM, Oct. 16, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), a leader in the development of oral peptide and protein replacement therapies, today announced that it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, Florida. This will mark Entera’s first presentation at NAMS.

The presentation will showcase new Phase 2 data from EB613 in early postmenopausal women with low bone mass or osteoporosis, examining bone mineral density outcomes over six months. By focusing on this population - a stage where women are at rising risk but few receive anabolic therapy - this analysis will examine the potential role of EB613 earlier in the treatment journey, where injectable options remain underutilized.

“Anabolic therapies remain significantly underutilized despite their proven ability to rebuild bone, largely because they are only available as injections,” said Miranda Toledano, Chief Executive Officer of Entera. “By delivering the first oral anabolic tablet, EB613 has the potential to move treatment earlier in the care continuum and broaden access for the over 200 million women worldwide living with osteoporosis. At NAMS, we will present new data examining the timing of intervention in postmenopausal women - an important clinical and market question.”

Presentation Details

• Conference: North American Menopause Society (NAMS) 2025 Annual Meeting
• Title: EB613 (Oral PTH[1-34] Tablets) Increases BMD Over 6 Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial
• Presentation Number: P-66
• Session Title: Poster Presentation
• Session Date/Time: Thursday, October, 23, 2025, 06:15 PM - 07:15 PM
• Place: Windemere Exhibit Hall

About EB613
Substantial evidence supports the efficacy of anabolic treatments over anti-resorptive drugs for lowering fracture risk in osteoporosis patients. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1-34)), is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 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 increased lumbar spine, total hip, and femoral neck BMD.

About Entera Bio
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 on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), 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. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). 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 metabolic syndromes; and first oral GLP-2 peptide 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, 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 and expected financial and operational results may constitute 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: 
Entera Bio:
Ms. Miranda Toledano
Chief Executive Officer, Entera Bio
Email: miranda@enterabio.com

FAQ

When will Entera Bio (ENTX) present EB613 Phase 2 data at NAMS 2025?

Entera will present on October 23, 2025, 6:15–7:15 PM (Poster P-66) in Windemere Exhibit Hall.

What population does the ENTX EB613 Phase 2 poster at NAMS cover?

The analysis covers early postmenopausal women with low bone mass or osteoporosis and reports six-month BMD outcomes.

What endpoints will Entera Bio (ENTX) report for EB613 at NAMS 2025?

The poster focuses on bone mineral density (BMD) changes over six months in the Phase 2 randomized trial.

How does EB613 differ from existing anabolic osteoporosis therapies mentioned in the ENTX announcement?

EB613 is described as an oral PTH[1-34] tablet, positioned as a potential non-injectable anabolic alternative to current injectable options.

Where and how can investors view the EB613 presentation at NAMS 2025?

The data will be presented as a poster (P-66) at NAMS on Oct 23, 2025 in Windemere Exhibit Hall; check NAMS or Entera investor channels for post-conference materials.

Why is the timing of intervention important in the ENTX EB613 Phase 2 analysis?

The presentation examines whether earlier anabolic treatment in the postmenopausal stage can broaden access and address underutilization of injectable anabolic therapies.