Entera Bio(US:ENTX) Globenewswire·2025-04-15 12:30Core Insights - Entera Bio Ltd. is developing EB613, the first once-daily oral anabolic PTH(1-34) tablet for postmenopausal women with osteoporosis at high risk for fracture [1][4] - The Phase 2 study showed significant increases in bone mineral density (BMD) at various skeletal sites compared to placebo, indicating a dual effect of stimulating bone formation and inhibiting resorption [1][2] - The company plans to initiate a Phase 3 registrational study for EB613 following positive Phase 2 results [5] Company Overview - Entera Bio is a clinical-stage company focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology [5] - The company's pipeline includes five differentiated oral peptide programs targeting conditions such as osteoporosis, hypoparathyroidism, and obesity [5] - EB613 is positioned as a solution for the treatment gap in osteoporosis care, aiming to provide a simple daily tablet for patients who currently lack effective treatment options [4][5] Clinical Study Findings - The Phase 2 study randomized 161 postmenopausal women and demonstrated early effects on trabecular and cortical bone, suggesting rapid bone strengthening and fracture resistance [2][3] - 3D-DXA analysis revealed substantial improvements in areal BMD at the total hip and femoral neck, consistent with results from subcutaneous teriparatide [3] - The study's findings indicate a broad distribution of bone loss with placebo and a similar distribution of bone gain with EB613 in the femur [2] Market Context - Osteoporosis affects approximately 200 million women globally, with a significant risk of fragility fractures, particularly in postmenopausal women [4] - Current injectable anabolic treatments are not viable for many patients, highlighting the need for an effective oral treatment like EB613 [4]