Core Insights - Entera Bio Ltd. is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs, utilizing its proprietary N-Tab™ technology platform [3] Company Overview - Entera Bio is developing first-in-class oral peptide programs targeting PTH(1-34), GLP-1, and GLP-2, with its most advanced product candidate, EB613, aimed at treating post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [3] - The company has successfully completed a placebo-controlled, dose-ranging Phase 2 study of EB613 tablets, which met both primary and secondary endpoints [3] - Other product candidates include EB612 for hypoparathyroidism and an oral oxyntomodulin for obesity and metabolic syndromes, as well as an oral GLP-2 peptide for rare malabsorption conditions in collaboration with OPKO Health [3] Upcoming Events - The CEO of Entera Bio, Miranda Toledano, will participate in a fireside chat at the 8th Annual Evercore ISI Healthcare Conference on December 3, 2024, in Coral Gables, Florida [2]

Core Insights - Entera Bio Ltd. will present new clinical data from its Phase 2 trial of EB613 at the North American Menopause Society (NAMS) 2025 Annual Meeting, marking its first presentation at this event [1][2] - The presentation will focus on bone mineral density outcomes in early postmenopausal women with low bone mass or osteoporosis, highlighting the potential role of EB613 in earlier treatment stages [2][3] Company Overview - Entera Bio is a clinical stage company developing oral peptide and protein replacement therapies, aiming to transform the standard of care for significant unmet medical needs [6] - The company's lead product candidate, EB613, is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis, specifically targeting postmenopausal women with low bone mass [5][6] Product Details - EB613 has shown efficacy in a Phase 2, 6-month, placebo-controlled study involving 161 patients, meeting all biomarker and bone mineral density endpoints without significant safety concerns [5] - The treatment produced rapid increases in biochemical markers of bone formation and reductions in markers of bone resorption, along with increased bone mineral density in key areas [5] Market Context - Anabolic therapies for osteoporosis are underutilized, primarily due to their availability only as injections, which limits access for many eligible patients [3][5] - Entera Bio's oral formulation of EB613 has the potential to broaden access for over 200 million women worldwide living with osteoporosis, addressing a critical gap in treatment options [3][5]

Core Viewpoint - Entera Bio Ltd. has received FDA agreement to support the NDA marketing application filing for EB613 based on a single 24-month phase 3 study, marking a significant regulatory milestone for the company and the osteoporosis community [1][2] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company's lead product candidate, EB613, is an oral anabolic treatment for post-menopausal women with low bone mineral density (BMD) and high-risk osteoporosis [5] Product Development - EB613 is designed as the first oral, once-daily anabolic tablet treatment for osteoporosis, aiming to increase skeletal mass, improve bone microarchitecture, and reduce fracture risk [3][4] - A phase 2 study of EB613 demonstrated significant efficacy, meeting all biomarker and BMD endpoints without major safety concerns [4] Regulatory Context - The FDA's agreement allows Entera to advance its clinical development program without waiting for the qualification of the SABRE initiative, which aims to establish BMD as a regulatory endpoint [2][6] - The SABRE initiative has shown that treatment-related gains in total-hip BMD can predict fracture-risk reduction, with a correlation coefficient of 0.73 [6] Market Need - Osteoporosis affects over 200 million women globally, with a significant portion remaining undertreated despite available injectable treatments [3] - The lack of new FDA-approved osteoporosis drugs since 2019 highlights the urgent need for innovative treatments like EB613 [3]

Core Insights - Entera Bio Ltd. is advancing EB613, an oral anabolic treatment for postmenopausal women with osteoporosis, which has been selected for presentation at the ASBMR 2025 Annual Meeting [1][4] - EB613 is designed to be the first once-daily oral PTH(1-34) tablet, aiming to provide a viable treatment option for patients at high risk of fractures [2][4] - The Phase 2 study demonstrated significant increases in bone mineral density (BMD) across all measured skeletal sites compared to baseline and placebo [2][4] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [5] - The company is preparing to initiate a Phase 3 registrational study for EB613 following FDA qualification of a quantitative BMD endpoint [5] - Entera's pipeline includes other innovative oral therapies targeting conditions such as hypoparathyroidism and obesity [5] Industry Context - Osteoporosis is a significant health concern, affecting approximately 200 million women globally, with a high risk of fragility fractures in older adults [3] - The current injectable anabolic treatments are not suitable for many patients, highlighting the need for oral alternatives like EB613 [4]