Entera Bio Ltd. submitted a streamlined Phase 3 protocol to the FDA on March 4, 2026, to initiate a registrational trial of EB613 (Next-Gen single tablet formulation) in 750 postmenopausal women with osteoporosis, using total hip BMD at 12 months as the primary endpoint. The company anticipates initiating the study in late 2026 with topline data in the second half of 2028, one year earlier than previously expected.
Key takeaways
Submitted Phase 3 protocol amendment, SAP, and open-label extension synopsis to FDA under IND 505(b)(2) for EB613
Phase 3 trial: multinational, randomized, double-blind, placebo-controlled in 750 postmenopausal women with osteoporosis
Primary endpoint: percentage change in total hip BMD from baseline to month 12
Next-Gen EB613 single tablet replaces multi-tablet formulation following successful bridging study
Study initiation planned for late 2026; topline data expected H2 2028
12-month open-label extension study to run in parallel with potential NDA review