Entera Bio Submits Streamlined Phase 3 Protocol for Osteoporosis Treatment.

Entera Bio has submitted a streamlined Phase 3 protocol to initiate a registrational program for EB613 in postmenopausal women with osteoporosis. The study will assess total hip BMD at 12 months, rather than 24 months, and will use a single tablet commercial formulation (Next-Gen EB613). Topline data is anticipated in H2 2028, approximately one year earlier than expected, with a 12-month extension study to run in parallel with potential NDA review.