Entera Bio Eyes H2 2028 Topline with 750-Patient Phase 3 EB613 Trial
Entera Bio submitted a streamlined Phase 3 protocol for its oral EB613 osteoporosis tablet, enrolling 750 postmenopausal women with primary endpoint of 12-month hip BMD change, aiming for late-2026 initiation and potential topline data by H2 2028. The FDA granted Type A alignment and qualified BMD as a surrogate endpoint.
1. Streamlined Phase 3 Protocol for EB613
In March 2026, Entera Bio submitted a streamlined Phase 3 protocol under IND 505(b)(2) for EB613, its oral PTH(1-34) anabolic tablet for osteoporosis. The multinational, randomized, double-blind, placebo-controlled study will enroll 750 postmenopausal women, use 12-month total hip BMD change as primary endpoint, and aims for late-2026 initiation with topline results by H2 2028.
2. FDA Endpoint Alignment and Qualification
The FDA granted Type A meeting alignment in July 2025 on using percentage change in total hip BMD at 24 months as a primary endpoint and agreed that a 12-month BMD outcome could serve as a validated surrogate for fracture risk. In December 2025, the FDA broadly qualified BMD percentage change at 24 months as a surrogate efficacy endpoint for novel osteoporosis drugs.
3. EB612 and EB618 Pre-IND Progress
Entera advanced EB612, a long-acting oral PTH replacement for hypoparathyroidism, selecting final variants and initiating pre-IND steps toward a late-2026 IND filing in partnership with OPKO. EB618, an oral OXM peptide for metabolic syndromes, completed PK/PD validation, with plans to file an IND and conduct Phase 1 SAD/MAD studies under OPKO collaboration.