Entera Bio Submits Streamlined Phase 3 Protocol to Initiate Registrational Program for EB613 in Postmenopausal Women with Osteoporosis

Core Insights - Entera Bio Ltd. has submitted a clinical amendment to the FDA for EB613, an oral anabolic treatment for osteoporosis, with a streamlined Phase 3 protocol and anticipates feedback within 60 days [1][2][5] - The Phase 3 trial will evaluate the efficacy of EB613 in increasing total hip bone mineral density (BMD) over 12 months, with a target enrollment of 750 postmenopausal women [3][5] - The company expects topline data in the second half of 2028, one year earlier than previously anticipated, and plans to conduct a 12-month open-label extension study in parallel with the NDA review [1][5] Company Overview - Entera Bio is focused on developing oral peptide and protein replacement therapies, with EB613 being the first oral anabolic tablet for osteoporosis [9] - The company utilizes a proprietary technology platform (N-Tab) to create innovative oral therapies, aiming to transform the standard of care in various medical fields [9] - Entera's pipeline includes other oral therapies for conditions such as hypoparathyroidism, obesity, and metabolic syndromes, indicating a broad focus on unmet medical needs [9] Industry Context - Osteoporosis is a significant public health issue, leading to over 2 million fractures annually in the US, with a projected increase in medical costs from $57 billion in 2018 to $95 billion by 2040 [8] - The disease predominantly affects postmenopausal women, with one in three women and one in five men likely to suffer an osteoporosis-related fracture after age 50 [8] - Current anabolic therapies for osteoporosis are administered via injection, limiting patient access; Entera's oral formulation aims to democratize treatment and improve patient compliance [6][8]