Entera Presents Markedly Enhanced Anabolic Effects of EB613 (First-in-Class Oral PTH(1-34) Tablet) in Postmenopausal Women with Osteoporosis at High Risk of Fracture and Showcases Phase 3 Design at ASBMR 2026 Annual Meeting
Entera Bio presented post-hoc Phase 2 data at ASBMR 2026 showing stronger anabolic effects of EB613, its first-in-class oral PTH(1-34) tablet, in postmenopausal women with osteoporosis (T-score ≤-2.5) versus osteopenia. Placebo-adjusted BMD gains at 6 months were 4.23% at total hip and 4.22% at lumbar spine in the osteoporosis subgroup, versus roughly 1-1.6% in higher-T-score patients, supporting the Phase 3 target population. The company also detailed its registrational Phase 3 design: a multinational, randomized, double-blind, placebo-controlled study of about 900 postmenopausal women randomized 2:1 to EB613 or placebo for 12 months, with Month 12 total hip BMD as the primary endpoint.
Key figures
- Drug Name
- EB613 (oral PTH(1-34), teriparatide)
- Phase Of Trial
- Phase 3 (design); post-hoc analysis of Phase 2
- Phase2 n
- 161
- Phase3 duration
- 12 months double-blind with extension to 24 months
- Phase3 planned n
- approximately 900 participants randomized 2:1 (EB613 ~600, placebo ~300)
- Phase3 primary endpoint
- change in Month 12 total hip BMD vs placebo
- Bmd gain osteoporosis total hip
- 4.23% placebo-adjusted at 6 months
- Bmd gain osteoporosis lumbar spine
- 4.22% placebo-adjusted at 6 months
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