Entera Bio presents data on EB613 in post-menopausal women with osteoporosis

Entera Bio (ENTX) announced data selected for presentation at the American Society for Bone and Mineral Research 2025 Annual Meeting in Seattle, Washington, for its lead program EB613 which is in late stage clinical development for post-menopausal women with osteoporosis. It is estimated that 50 percent of women and 20 percent of men over the age of 50 are at risk of a fragility fractures and less than 30% of patients are adequately treated with available medications. In the oral presentation titled “Effects of EB613 Tablets on Trabecular and Cortical Bone Using 3D-DXA: Results from Phase 2 Study,” Rachel B. Wagman, MD presented data using 3D-DXA modelling in a post-hoc analysis of EB613 Phase 2 results to look at the treatment’s impact on trabecular and cortical bone. After 6 months of treatment, EB613 2.5 mg demonstrated significant increases in both trabecular and cortical bone parameters as compared with placebo. Mechanistically, the findings suggest that bone strengthening, and fracture resistance may occur rapidly with EB613. Increases in integral volumetric BMD of the TH and FN by 1.7% and 2.6%, respectively Increases in FN trabecular volumetric BMD by 4.4% vs. placebo and increases in TH trabecular volumetric BMD by 2.8% Increases in cortical thickness at the TH and FN by 1.3% and 1.7%, respectively Improvements in cortical surface BMD at the TH and FN by 1.5% and 2.1%, respectively In a poster presentation titled “Advancing Oral Anabolic Treatments for Osteoporosis: Pre-Clinical Data for Next-Gen EB613 Tablet Utilizing N-Tab Proprietary Technology,” Entera presented preclinical data for its Next-Gen EB613 candidate. In a cross-over pharmacokinetic study in minipigs, a single 1.5 mg Next-Gen EB613 tablet demonstrated comparable PK to the current formulation of EB613, with identical AUClast and Tmax values, and comparable Cmax. A Phase 1 clinical trial of Next-Gen EB613 is planned to begin in late 2025.