Consistency of BMD gains provided at NAMS 2025 show EB613’s effectiveness in both young postmenopausal females and in females ten years post-menopause
Information even more support EB613 capacity as a first-in-class oral anabolic treatment alternative that might considerably broaden client access to bone-building treatment
Entera Strategies to Start International Registrational Stage 3 Research Study Following July 2025 FDA Concurrence
JERUSALEM, Oct. 23, 2025 (WORLD NEWSWIRE)– Entera Bio Ltd. (NASDAQ: ENTX), a leader in the advancement of oral peptide and protein replacement treatments, today reported brand-new scientific information from a post-hoc analysis of its Stage 2 trial of EB613, at the 2025 North American Menopause Society (NAMS) Yearly Fulfilling in a poster discussion entitled ” EB613 (Oral PTH[1-34] Tablets) Boosts BMD Over 6 Months in Early Postmenopausal Females with Low Bone Mass or Osteoporosis: A Stage 2 Randomized Trial (P-66).”
EB613, Entera’s once-daily oral PTH( 1-34) anabolic tablet, is being established as the very first oral bone-building treatment for postmenopausal females at high danger for fracture. In spite of clear scientific standards suggesting anabolic representatives for their remarkable advantages, these treatments stay considerably underutilized due to injectable administration and high expenses. In this brand-new analysis of the Stage 2 trial, EB613 showed its impact at the 2.5 mg dosage (the program chosen for the upcoming Stage 3 research study) by producing considerable and constant gains in bone mineral density (BMD) at the spinal column, femoral neck and hip in females within ten years of menopause, with enhancements equivalent to those observed in females more than ten years post-menopause.
” These findings show that EB613 produces considerable BMD enhancements in early postmenopausal females, a crucial population for fracture avoidance,” stated Steven R. Goldstein, MD, Teacher of Obstetrics and Gynecology at NYU School of Medication and member of Entera’s Medical and Scientific Board Of Advisers, who provided the information at NAMS. “What’s especially considerable is the consistency of reaction throughout various phases of menopause. The reality that we’re seeing these outcomes with an oral formula addresses among the most considerable barriers in osteoporosis care, unlocking to present anabolic treatment previously in the treatment journey, when injectable choices are seldom utilized. This might be a game-changer for client gain access to and compliance.”
Secret Findings
In early postmenopausal females (ā¤ ten years because last menstrual duration), EB613 (n= 8) versus placebo (n= 19), statistically considerable BMD boosts were observed at 6 months:
- Back spinal column: 3.1% boost vs placebo at 6 months (p= 0.05), showing considerable bone density gains at a crucial fracture website.
- Overall hip: 2.3% boost vs placebo (p= 0.03), showing significant enhancements in general bone strength.
- Femoral neck: 2.0% boost, constant with gains observed in later postmenopausal females.
These outcomes were equivalent to BMD enhancements seen in females more than ten years post-menopause, where EB613 increased femoral neck BMD by 3.2% (p= 0.02) and back spinal column BMD by 2.5% (p= 0.08).
” EB613 has the possible to change how osteoporosis is dealt with by bringing anabolic treatment into earlier phases of care, where it is seldom utilized today,” stated Miranda Toledano, Ceo of Entera Bio. “By providing bone-building treatment in a hassle-free oral tablet, we can expand gain access to for countless postmenopausal females at danger of fracture and leader the very first oral anabolic treatment alternative to resolve this important unmet requirement.
About EB613
Considerable proof supports the effectiveness of anabolic treatments over anti-resorptive drugs for reducing fracture danger in osteoporosis clients. Nevertheless, all readily available anabolic treatments are administered by subcutaneous (SC) injection and utilized in a minority of qualified clients. EB613 (oral PTH (1-34)), is being established as the very first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 finished a stage 2, 6-month, 161-patient, placebo-controlled research study that fulfilled all biomarker and BMD endpoints without considerable security issues in females with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced fast dose-proportional boosts in biochemical markers of bone development, decreases in markers of bone resorption, and increased back spinal column, overall hip, and femoral neck BMD.
About Entera Bio
Entera is a medical phase business concentrated on establishing oral peptide and protein replacement treatments for considerable unmet medical requirements where an oral tablet kind holds the possible to change the requirement of care. The Business leverages on a disruptive and exclusive innovation platform (N-Tab ā¢) and its pipeline of first-in-class oral peptide programs targeting PTH( 1-34), GLP-1 and GLP-2. The Business’s most innovative item prospect, EB613 (oral PTH( 1-34), teriparatide), is being established as the very first oral, osteoanabolic (bone structure) once-daily tablet treatment for post-menopausal females with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Stage 2 research study of EB613 tablets (n= 161) fulfilled main (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being established as the very first oral PTH( 1-34) tablet peptide replacement treatment for hypoparathyroidism. Entera is likewise establishing the very first oral oxyntomodulin, a double targeted GLP1/glucagon peptide, in tablet kind for the treatment of weight problems and metabolic syndromes; and initially oral GLP-2 peptide as an injection-free option for clients experiencing uncommon malabsorption conditions such as brief bowel syndrome in partnership with OPKO Health. To learn more on Entera Bio, visitĀ www.enterabio.com or follow us on LinkedIn, Twitter, and Facebook.
Cautionary Declaration Relating To Forward Looking Declarations
Numerous declarations in this news release are “positive declarations” within the significance of the Personal Securities Lawsuits Reform Act of 1995. All declarations (besides declarations of historic realities) in this news release concerning our potential customers, strategies, monetary position, company technique and anticipated monetary and functional outcomes might make up positive declarations. Words such as, however not restricted to, “expect,” “think,” “can,” “could,” “anticipate,” “price quote,” “style,” “objective,” “plan,” “might,” “might,” “unbiased,” “strategy,” “forecast,” “job,” “target,” “likely,” “should,” “will,” and “would,” or the unfavorable of these terms and comparable expressions or words, recognize positive declarations. Positive declarations are based upon existing expectations that include threats, modifications in scenarios, presumptions and unpredictabilities. Positive declarations ought to not read as a warranty of future efficiency or outcomes and might not be precise signs of when such efficiency or outcomes will be accomplished. Essential elements that might trigger real outcomes to vary materially from those shown in Entera’s positive declarations consist of, to name a few: modifications in the analysis of scientific information; outcomes of our scientific trials; the FDA’s analysis and evaluation of our arise from and analysis of our scientific trials; unforeseen modifications in our continuous and scheduled preclinical advancement and scientific trials, the timing of and our capability to make regulative filings and get and keep regulative approvals for our item prospects; the possible disturbance and hold-up of making supply chains; loss of readily available labor force resources, either by Entera or its partnership and lab partners; effects to research study and advancement or scientific activities that Entera might be contractually bound to offer; general regulative timelines; the size and development of the possible markets for our item prospects; the scope, development and expenses of establishing Entera’s item prospects; Entera’s dependence on 3rd parties to perform its scientific trials; Entera’s capability to develop and keep advancement and commercialization partnerships; Entera’s operation as an advancement phase business with minimal operating history; Entera’s competitive position with regard to other items on the marketplace or in advancement for the treatment of osteoporosis, hypoparathyroidism, brief bowel syndrome, weight problems, metabolic conditions and other illness classifications it pursues; Entera’s capability to continue as a going issue missing access to sources of liquidity; Entera’s capability to get and keep regulative approval for any of its item prospects; Entera’s capability to abide by Nasdaq’s minimum listing requirements and other matters associated with compliance with the requirements of being a public business in the United States; Entera’s copyright position and its capability to safeguard its copyright; and other elements that are explained in the “Cautionary Declaration Relating To Positive Declarations,” “Danger Elements” and “Management’s Conversation and Analysis of Financial Condition and Outcomes of Operations” areas of Entera’s latest Yearly Report on Type 10-K submitted with the SEC, along with Entera’s consequently submitted Quarterly Reports on Type 10-Q and Present Reports on Type 8-K. There can be no guarantee that the real outcomes or advancements prepared for by Entera will be understood or, even if considerably understood, that they will have the anticipated effects to, or impacts on, Entera. For that reason, no guarantee can be considered that the results specified or suggested in such positive declarations and quotes will be accomplished. Entera warns financiers not to count on the positive declarations Entera makes in this news release. The info in this news release is supplied just since the date of this news release, and Entera carries out no responsibility to upgrade or modify openly any positive declarations, whether as an outcome of brand-new info, future occasions or otherwise, other than to the degree needed by law.
Contacts:
Entera Bio:
Ms. Miranda Toledano
Ceo, Entera Bio
Email: miranda@enterabio.com