EB613

June 15, 2026: Entera Bio Ltd. (NASDAQ: ENTX) reported comparative Phase 1 data (NCT05965167) on single-tablet oral EB613 vs multi-tablet oral EB613 and subcutaneous Forteo® (teriparatide) in 15 healthy participants, presented as a late-breaking oral presentation at ENDO 2026 (Endocrine Society, Chicago). Across 1–3 mg doses, single-tablet EB613 showed a PK profile comparable to multi-tablet EB613 (similar Cmax, Tmax, AUC). Single- and multi-tablet EB613 AUC was comparable to Forteo®, with slightly shorter exposure duration. PD findings included comparable calcemic effects (serum calcium) and consistent suppression of endogenous PTH(1-84) for both oral EB613 formulations and Forteo®. Safety was consistent with Forteo®, with no drug-related serious adverse events; other adverse events were mild and resolved without intervention. In a dosing experience questionnaire, 14/15 participants preferred the single tablet over multi-tablet EB613, and all preferred daily oral dosing over daily injection.

Entera said these results support advancing single-tablet EB613 as the final candidate for its planned Phase 3 study in postmenopausal women with osteoporosis. The release also notes EB613 previously completed a 6-month, 161-patient placebo-controlled Phase 2 study that met biomarker and BMD endpoints without significant safety concerns.