Entera Bio to Present Phase 2 Osteoporosis Data and Next-Generation Oral Peptide Programs at September 2025 Conferences
核心洞察
Entera Bio will present Phase 2 data for EB613, the first once-daily oral anabolic tablet for postmenopausal osteoporosis (搜索), showing rapid BMD increases at both cortical and cancellous bone sites.
The company plans a global Phase 3 registration study for EB613 following FDA alignment in July 2025, targeting the significant unmet need in osteoporosis (搜索) treatment.
Data on next-generation EB613 utilizing proprietary N-Tab technology and a first-in-class oral GLP-2 (搜索) analog for short bowel syndrome (搜索) will also be presented at ASBMR and ESPEN conferences.
Entera Bio (ENTX) will present clinical and preclinical data across three oral peptide programs at major medical conferences in September 2025, including pivotal Phase 2 results for its osteoporosis (搜索) candidate EB613 and novel approaches to treating short bowel syndrome (搜索).
Phase 2 Osteoporosis Results Show Dual Bone Benefits
At the American Society for Bone and Mineral Research (ASBMR) 2025 Annual Meeting, Entera will present data titled "Effects of EB613 Tablets on Trabecular and Cortical Bone Using 3D-DXA: Results from Phase 2 Study." The presentation will detail results from a placebo-controlled Phase 2 study involving 161 postmenopausal women with osteoporosis (搜索).
EB613 is being developed as the first once-daily oral anabolic tablet treatment for postmenopausal women with osteoporosis (搜索). The Phase 2 study demonstrated rapid onset of action with increases in bone mineral density (BMD) at both cortical bone and cancellous bone sites, representing a significant advancement in osteoporosis treatment approaches.
FDA Alignment Paves Way for Phase 3 Registration
Based on alignment with the FDA achieved in July 2025, Entera is planning a global Phase 3 registration study of EB613 in women with osteoporosis (搜索). This regulatory milestone positions the company to advance toward potential market approval for what could be the first oral anabolic treatment option in this therapeutic area.
Next-Generation Technology and Pipeline Expansion
The company will also present preclinical data on its next-generation EB613 formulation in a poster titled "Advancing Oral Anabolic Treatments for Osteoporosis (搜索): Pre-Clinical Data for Next-Gen EB613 Tablet Utilizing N-Tab Proprietary Technology." This presentation will showcase advances in Entera's proprietary oral delivery platform.
First-in-Class GLP-2 Program for Rare Disease
At the European Society for Clinical Nutrition and Metabolism (ESPEN) conference, Entera will present poster data on "A First-in-Class Oral GLP-2 (搜索) Analog for Treatment of Short Bowel Syndrome (搜索)." The oral GLP-2 tablet program combines a proprietary long-acting GLP-2 agonist (搜索) developed by OPKO Health (搜索) with Entera's N-Tab technology.
This program targets patients suffering from short bowel syndrome (搜索) and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP-2 agonist (搜索) requires daily subcutaneous injections, highlighting the potential convenience advantage of an oral formulation.
The September 2025 presentations will provide comprehensive updates on Entera's oral peptide delivery platform across multiple therapeutic areas, with particular focus on the company's lead osteoporosis (搜索) program as it advances toward Phase 3 development.