Entera Bio Congratulates the FNIH-ASBMR-SABRE Team on FDA’s Qualification of Total Hip BMD as Regulatory Endpoint: Huge Win for Osteoporosis Innovation

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]