First-time presentation examining bone outcomes in early postmenopausal womenJERUSALEM, 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 pres ...

Core Viewpoint - Entera Bio Ltd. has received FDA agreement to support the NDA marketing application filing for EB613 based on a single 24-month phase 3 study, marking a significant regulatory milestone for the company and the osteoporosis community [1][2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product candidate, EB613, is an oral anabolic treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [5] Product Development - EB613 is designed as the first oral, once-daily anabolic tablet treatment for osteoporosis, aiming to increase skeletal mass, improve bone microarchitecture, and reduce fracture risk [3][4] - A phase 2 study of EB613 demonstrated significant efficacy, meeting all biomarker and BMD endpoints without major safety concerns [4] Regulatory Context - The FDA's agreement allows Entera to advance its clinical development program without waiting for the qualification of the SABRE initiative, which aims to establish BMD as a regulatory endpoint [2][6] - The SABRE initiative has shown that treatment-related gains in total-hip BMD can predict fracture-risk reduction, with a correlation coefficient of 0.73 [6] Market Need - Osteoporosis affects over 200 million women globally, with a significant portion remaining undertreated despite available injectable treatments [3] - The lack of new FDA-approved osteoporosis drugs since 2019 highlights the urgent need for innovative treatments like EB613 [3]

Entera Bio's N-Tab Platform and Pipeline - Entera Bio's proprietary N-Tab platform transforms peptides into orally bioavailable tablets, potentially unlocking patient acceptance and driving superior health outcomes[7, 19] - The company's lead asset, EB613, is a differentiated Phase 3 asset poised for blockbuster sales as a first-in-class oral PTH(1-34) anabolic tablet treatment for osteoporosis, a condition affecting over 200 million people worldwide[7, 27] - Entera has a rich pipeline with multiple blockbuster opportunities in high-impact therapeutic areas, including EB612 for hypoparathyroidism, OXM for obesity/metabolic disorders, and GLP-2 for GI inflammatory disorders and short bowel syndrome[7, 8] - The company's cash runway extends into H2 2026, with multiple catalysts expected in the next 12 months[8] EB613 for Osteoporosis - EB613 is positioned as the first oral anabolic treatment to support earlier intervention in osteoporosis, addressing a substantial treatment gap[7, 28] - A Phase 2 study of EB613 in post-menopausal women with low bone mass or osteoporosis demonstrated a faster onset of action and higher increases in BMD at the cortical bone (femoral neck and hip region)[23] - EB613's Phase 2 results showed a distinct dual mechanism of increased bone formation (P1NP) and reduced bone resorption (CTX)[44] - Phase 2 data indicated that EB613 increased BMD at all major skeletal sites, with placebo-adjusted BMD change of EB613 2.5mg from Baseline to Month 6 as Compared with Published Forteo® Data[56, 57] GLP-1/Glucagon and GLP-2 Programs - Entera is developing an oral GLP-1/Glucagon (OXM) dual agonist tablet for metabolic disorders and obesity in partnership with OPKO, with an IND filing expected late 2025/early 2026[8, 104, 116] - Pre-clinical data supports the development of once-daily oral GLP-2 analog tablets for short bowel syndrome (SBS), a rare disease affecting approximately 30,000 patients across the US and EU[8, 106, 108]

Core Insights - Entera Bio Ltd. is advancing EB613, an oral anabolic treatment for postmenopausal women with osteoporosis, which has been selected for presentation at the ASBMR 2025 Annual Meeting [1][4] - EB613 is designed to be the first once-daily oral PTH(1-34) tablet, aiming to provide a viable treatment option for patients at high risk of fractures [2][4] - The Phase 2 study demonstrated significant increases in bone mineral density (BMD) across all measured skeletal sites compared to baseline and placebo [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] - Entera's pipeline includes other innovative oral therapies targeting conditions such as hypoparathyroidism and obesity [5] Industry Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures in older adults [3] - The current injectable anabolic treatments are not suitable for many patients, highlighting the need for oral alternatives like EB613 [4]

Core Insights - Entera Bio Ltd. announced positive results from a Phase 2 study of EB613, an oral PTH(1-34) tablet aimed at treating postmenopausal women with osteoporosis at high risk for fractures [1][2][4] - The study demonstrated significant increases in bone mineral density (BMD) across various skeletal sites compared to placebo, indicating the potential for rapid bone strengthening and fracture resistance [2][3] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product, EB613, is positioned as the first oral anabolic treatment for postmenopausal women with low BMD and high-risk osteoporosis [5] - Entera is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] Study Details - The Phase 2 study involved 161 postmenopausal women and assessed the effects of EB613 over 6 months, showing improvements in integral volumetric BMD, trabecular volumetric BMD, cortical thickness, and cortical surface BMD compared to placebo [2][3] - 3D-DXA analysis indicated a dual effect of EB613, stimulating bone formation while inhibiting resorption, with significant improvements noted in both trabecular and cortical bone [1][2] Market Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment option like EB613 [4]