Entera Bio Ltd. has reached an agreement with the FDA to use bone mineral density (BMD) as the primary endpoint for the registrational Phase 3 study of EB613, an oral peptide treatment for osteoporosis. Phase 2 data has shown consistent efficacy in post-menopausal women with osteoporosis. The company’s next-generation EB613 is set to begin Phase 1 trials in late 2025. Additionally, pre-clinical data for oral OXM in obesity and oral GLP-2 in short bowel syndrome were presented at medical conferences. Entera Bio reported financial results for the quarter ended September 30, 2025, with cash and cash equivalents of $16.6 million.

The FDA has agreed to Entera Bio’s proposal to use BMD as the primary endpoint for the Phase 3 study of EB613, a potential oral treatment for osteoporosis. Phase 2 data has shown significant improvements in bone density for post-menopausal women. The company is also progressing with its next-generation EB613 and presenting pre-clinical data for oral peptide treatments in obesity and short bowel syndrome. Financially, Entera Bio reported cash and cash equivalents of $16.6 million for the quarter ended September 30, 2025, with ongoing research and development activities.

Read more at GlobeNewswire: Entera Bio Announces Third Quarter 2025 Financial Results