Entera Bio Presents Positive Effects of EB613 on Both Trabecular and Cortical Bone in Postmenopausal Women with Osteoporosis at ASBMR 2025

Core Insights - Entera Bio Ltd. announced significant results from its Phase 2 study of EB613, an oral treatment for osteoporosis, showing improvements in both trabecular and cortical bone after just 6 months of treatment [1][2][4] - The company plans to initiate a global registrational Phase 3 study following FDA concurrence in July 2025 [1][4] - EB613 is positioned as a viable alternative to injectable anabolic treatments, which are currently underutilized due to accessibility issues [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [6] - The company's lead product, EB613, is the first oral anabolic treatment for post-menopausal women with osteoporosis, aiming to address significant unmet medical needs [6] - Entera is also developing other oral peptide therapies targeting conditions such as hypoparathyroidism and obesity [6] Clinical Study Results - The Phase 2 study of EB613 involved 161 patients and met all primary and secondary endpoints, demonstrating significant increases in bone mineral density (BMD) and favorable safety profiles [4][5] - Key findings included a 1.7% increase in integral volumetric BMD of the total hip and a 2.6% increase in the femoral neck compared to placebo [5] - Improvements in cortical thickness and surface BMD were also observed, indicating early strengthening effects of EB613 [3][5] Future Developments - Entera plans to begin a Phase 1 clinical trial for its Next-Gen EB613 tablet in late 2025, which has shown comparable pharmacokinetic properties to the current formulation [3][4] - The company aims to address the treatment gap in osteoporosis care with its oral formulation, which is expected to enhance patient compliance and accessibility [2][4]