Entera Bio unveils Phase 3 design for EB613 oral osteoporosis tablet trial
ENTX•Entera Bio presented a planned 12-month, placebo-controlled Phase 3 trial of EB613 in about 900 postmenopausal women, with a 24-month extension to assess longer-term safety and durability.
1. Phase 3 trial design
Entera Bio presented a registrational Phase 3 design for EB613, an oral osteoporosis drug candidate. The planned study will compare the tablet with placebo for 12 months in about 900 postmenopausal women, followed by a 24-month extension to assess longer-term safety and durability.
2. Phase 2 analyses
The company also highlighted Phase 2 analyses presented at the ASBMR 2026 annual meeting. Results pointed to stronger bone-building effects in higher-risk women than in less severe patients. The program targets registration based on improvement in bone density, and EB613 is positioned as a potential alternative to daily injections.
