Entera Bio Ltd. presented comparative Phase 1 data at ENDO 2026 demonstrating that its single tablet EB613 achieved pharmacokinetic (PK) and pharmacodynamic (PD) profiles comparable to both multi-tablet EB613 and the standard injectable Forteo® (teriparatide SC injection, Eli Lilly). The findings support advancing the single tablet regimen as the final candidate for a planned Phase 3 study in postmenopausal women with osteoporosis, potentially simplifying treatment protocols for patients who currently rely on daily or monthly injections.

The oral presentation, titled "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," was delivered by Clinical Pharmacologist Helen S. Pentikis, PhD. It was featured as a Late-Breaking Oral Presentation at ENDO 2026, the annual meeting of the Endocrine Society, held in Chicago, Illinois.

Key Clinical Findings

The Phase 1 study (NCT05965167) evaluated 15 healthy participants who received single-tablet EB613, multi-tablet oral EB613, and subcutaneous Forteo® at doses ranging from 1 mg to 3 mg. The data indicated that single tablet EB613 showed a PK profile comparable to multi-tablet EB613, with similar Cmax, Tmax, and total systemic exposure (AUC). The AUC of both oral formulations was comparable with Forteo®, exhibiting a slightly shorter duration of exposure consistent with prior Phase 1 studies.

Comparable calcemic effects (serum calcium) and consistent suppression of endogenous PTH(1-84) were observed for both oral EB613 treatments and Forteo®. The safety profile of EB613 was consistent with Forteo®, with no drug-related serious adverse events; all other adverse events were mild and resolved with no action taken.

Patient Preference and Strategic Impact

Based on an administration experience quality-of-life questionnaire, 14 of 15 participants preferred the single tablet to multi-tablet EB613, and all participants preferred a daily oral EB613 over the daily injection. Miranda Toledano, Chief Executive Officer of Entera, stated that simplifying the dosing regimen to a single daily tablet could make anabolic treatment far more acceptable to patients and healthcare providers, potentially reducing the treatment gap in osteoporosis.

Entera Bio focuses on the development of oral peptides, and the EB613 program represents a core component of its pipeline. The company is developing EB613 as the first oral, once-daily anabolic tablet treatment for osteoporosis, aiming to provide an alternative to injectable therapies like Forteo®, Tymlos®, and Evenity®.