Core Insights - Entera Bio Ltd. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports its regulatory strategy for EB613 [1][2] - The company aims to democratize anabolic treatment for osteoporosis, addressing the significant unmet medical needs of over 200 million women globally who are estimated to have osteoporosis [2][5] Company Overview - Entera is a clinical-stage company focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [7] - The company's lead product, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis [4][7] Product Development - EB613 has shown efficacy in a Phase 2 study, meeting all biomarker and BMD endpoints without significant safety concerns, indicating its potential as a transformative treatment option [4] - The FDA's broad qualification of total hip BMD may simplify the regulatory pathway for EB613, allowing for a single Phase 3 study to support a New Drug Application (NDA) [2][3] Industry Context - Osteoporosis is a major public health issue, responsible for over 2 million fractures annually in the US, with significant medical costs projected to rise from $57 billion in 2018 to $95 billion by 2040 [5] - The aging population is expected to increase the incidence of osteoporosis-related fractures, highlighting the need for novel products with enhanced efficacy and ease of use [6]

Core Insights - Entera Bio Ltd. has received FDA qualification for total hip bone mineral density (BMD) as a validated regulatory endpoint for osteoporosis drug development, which supports the company's strategy for its product EB613 [1][2] - The FDA's position may simplify the regulatory pathway for Entera, allowing a single Phase 3 study with total hip BMD as the primary endpoint to support a New Drug Application (NDA) for EB613 [2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [7] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis [4][7] Industry Context - Osteoporosis affects over 200 million women globally, with a significant number remaining undertreated; no new osteoporosis drug has been approved by the FDA since 2019 [2][5] - Osteoporosis is a major public health issue, leading to over 2 million fractures annually in the US, with projected medical costs for osteoporotic fractures expected to rise from $57 billion in 2018 to $95 billion by 2040 [5] Product Development - EB613 has shown efficacy in a Phase 2 study, meeting all biomarker and BMD endpoints without significant safety concerns, indicating its potential as a novel treatment option [4] - The development of validated surrogate endpoints like BMD may facilitate faster drug development and address the ethical challenges associated with osteoporosis clinical trials [6]

Summary of Entera Bio Ltd. Conference Call Company Overview - **Company**: Entera Bio Ltd. - **Industry**: Biopharmaceuticals - **Focus**: Development of first-in-class oral peptide therapies for unmet medical needs - **Ticker Symbol**: ENTX (listed on NASDAQ) - **Cash Runway**: Expected to last until Q3 2026 [2][24] Core Technology and Pipeline - **Technology Platform**: NTAB technology platform enables the development of oral peptide therapies in tablet form, overcoming challenges such as proteolytic degradation and molecular polarity [2][3][4] - **Lead Asset**: EB613, the only oral peptide in development for osteoporosis, is set to enter a phase 3 registrational study [2][4][17] - **Other Pipeline Assets**: Include treatments for hypoparathyroidism, metabolic disorders, obesity, and gastrointestinal inflammation [2][4] EB613 Details - **Mechanism of Action**: EB613 is a PTH(1-34) teriparatide tablet that stimulates bone formation and suppresses bone resorption, aiming to provide a validated mechanism of action in a convenient oral format [6][10][12] - **Clinical Studies**: Phase 2 studies showed favorable outcomes in bone formation markers and bone mineral density (BMD) across skeletal sites [12][13][14] - **Comparison with Forteo**: EB613 has a similar amino acid sequence to Forteo but offers a more rapid onset of action and improved BMD outcomes, particularly at the hip [6][14][15] Osteoporosis Market Insights - **Prevalence**: Approximately 200 million women globally are affected by osteoporosis, with significant fracture risks [7][8] - **Current Treatment Landscape**: Most treatments are antiresorptive drugs, with bisphosphonates being the most commonly prescribed [9][10] - **Patient Access Issues**: Many patients do not receive adequate treatment due to the limitations of injectable therapies and the need for healthcare provider resources [11][19] Phase 3 Study Plans - **Study Design**: A double-blind, placebo-controlled, 24-month study focusing on total hip BMD as the primary endpoint, with secondary endpoints including vertebral fracture trends [17][18] - **Regulatory Alignment**: Recent agreement with the FDA allows the use of total hip BMD as a primary endpoint, a significant milestone for the company [18][23] Market Research and Patient Insights - **Clinician Feedback**: 30% of osteoporosis patients experience suboptimal responses to current treatments, highlighting a need for more effective solutions [19] - **Patient Interest**: 55% of surveyed patients expressed interest in oral bone-building treatments, indicating a potential market for EB613 [19] Future Developments - **Partnership with OPKO Health**: Development of an oral oxyntomodulin tablet is underway, with an IND filing expected in early 2026 [5][20] - **Additional Programs**: Plans to validate a different peptide for hypoparathyroidism and to present supplemental data at upcoming conferences [23] Conclusion - Entera Bio Ltd. is positioned to address significant unmet needs in osteoporosis treatment with its innovative oral peptide therapies, particularly EB613, which aims to enhance patient access and compliance compared to existing injectable options [2][19][24]

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]