Clinical TrialJun 15, 2026, 08:46 AM
Entera Bio's Single-Tablet EB613 Matches Forteo® PK/PD; Advances to Phase 3
AI Summary
Entera Bio Ltd. reported positive comparative Phase 1 data for its oral osteoporosis treatment, EB613, at ENDO 2026. The single-tablet formulation of EB613 demonstrated a pharmacokinetic (PK) and pharmacodynamic (PD) profile comparable to both the multi-tablet version and Forteo® (teriparatide SC injection). This significant scientific achievement supports the advancement of single-tablet EB613 into Entera's planned Phase 3 study for postmenopausal women with osteoporosis, offering a potential oral anabolic treatment alternative to daily injections.
Key Highlights
- Single-tablet EB613 showed comparable PK/PD profile to multi-tablet EB613 and Forteo®.
- Single-tablet EB613 exhibited similar Cmax, Tmax, and total systemic exposure (AUC) to multi-tablet EB613.
- AUC of single-tablet and multi-tablet EB613 was comparable with Forteo®.
- Both oral EB613 treatments and Forteo® showed comparable calcemic effects and consistent suppression of endogenous PTH(1-84).
- EB613's safety profile was consistent with Forteo®, with no drug-related serious adverse events.
- 14 of 15 participants preferred single-tablet EB613 to multi-tablet, and all preferred oral over daily injection.
- Data supports advancing single-tablet EB613 into a planned Phase 3 study for osteoporosis.
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