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 the company's strategy for its product EB613 [1][2] - The FDA's position may simplify the regulatory pathway for Entera, allowing a single Phase 3 study with total hip BMD as the primary endpoint to support a New Drug Application (NDA) for EB613 [2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [7] - The company's lead product candidate, 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] Industry Context - Osteoporosis affects over 200 million women globally, with a significant number remaining undertreated; no new osteoporosis drug has been approved by the FDA since 2019 [2][5] - Osteoporosis is a major public health issue, leading to over 2 million fractures annually in the US, with projected medical costs for osteoporotic fractures expected to rise from $57 billion in 2018 to $95 billion by 2040 [5] 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 novel treatment option [4] - The development of validated surrogate endpoints like BMD may facilitate faster drug development and address the ethical challenges associated with osteoporosis clinical trials [6]