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Bone and Mineral Metabolism

ORF37-02 - Transforming Anabolic Treatments for Osteoporosis: New Clinical Data Supports a Single EB613 Tablet [Oral PTH(1-34)] as the Final Candidate for a Phase 3 Study

Sunday, June 14, 2026
3:30 PM - 4:15 PM CT
Osteoporosis is a chronic, progressive disorder characterized by an imbalance between bone resorption and formation, resulting in reduced bone strength and increased fracture risk. In the US, this condition leads to over 2 million fractures annually and is associated with chronic pain, decreased quality of life, disability, and premature death [1]. Substantial evidence demonstrates that anabolic therapies are more effective than anti-resorptive therapies for lowering fracture risk in osteoporosis patients at high risk. However, currently available anabolic therapies are administered by subcutaneous (SC) injection and thus are used only in a minority of eligible patients.
EB613 [oral PTH(1-34), teriparatide] is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis utilizing Entera’s oral peptide platform, N-Tab®. EB613 doses of up to 2.5 mg were investigated in a phase 2, 6-month, placebo-controlled study in 161 women with postmenopausal osteoporosis or low BMD. Dose-dependent increments in spine, total hip, and femoral neck BMD were associated with stimulation of bone formation and suppression of bone resorption [2].
Here we report the pharmacokinetic (PK) evaluation of a simplified, single-tablet formulation of EB613 conducted in healthy volunteers (n=15) as part of a recently completed phase 1 PK and safety bridging study (NCT05965167). The single tablet (2.5 mg) was compared to the multi-tablet dosage form (2.5 mg; 0.5 mg tablet x 5) tested in the phase 2 study and to the commercial Forteo® injection. Plasma levels of PTH(1-34) were measured at predetermined timepoints for three hours post-dose. Preliminary analysis demonstrates comparable PK profiles between the single and multi-tablet EB613 formulations with similar Tmax, Cmax, and total systemic exposure (AUC) parameters. The total systemic exposure of EB613 was comparable also to that of the injectable teriparatide. Both single and multi-tablet EB613 treatments were safe and well tolerated.
Together with the successful phase 2 trial, these PK findings provide a robust scientific rationale for advancing the simplified single-tablet EB613 formulation into a phase 3 registrational study in patients with osteoporosis.
[1] U.S. Food and Drug Administration. (2025, December 19). https://www.fda.gov/drugs/drug-safety-and-availability/fda-qualifies-total-hip-bone-mineral-density-bmd-surrogate-endpoint-osteoporosis-drug-development
[2] Tripto-Shkolnik L, et al. JBMR 2024;39(6):672-82

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