Entera reports comparable results for single-tablet EB613 versus injection

Entera Bio Ltd. (NASDAQ: ENTX) reported Phase 1 clinical data showing its single-tablet oral EB613 achieved comparable pharmacokinetic and pharmacodynamic profiles to both its multi-tablet version and Forteo injection for osteoporosis treatment.

The study involved 15 healthy participants who received single-tablet EB613, multi-tablet EB613, and subcutaneous Forteo at doses ranging from 1 mg to 3 mg. Results showed the single tablet demonstrated similar maximum concentration, time to maximum concentration, and total systemic exposure compared to the multi-tablet formulation.

Both oral EB613 formulations showed comparable area under the curve to Forteo, with a slightly shorter duration of exposure consistent with prior Phase 1 studies. The treatments produced comparable effects on serum calcium and consistent suppression of endogenous PTH.

The safety profile of EB613 was consistent with Forteo, with no drug-related serious adverse events reported. All other adverse events were mild and resolved without intervention. In a quality-of-life questionnaire, 14 of 15 participants preferred the single tablet over the multi-tablet version, and all participants preferred daily oral treatment over daily injection.

The data was presented at ENDO 2026, the annual meeting of the Endocrine Society in Chicago. Entera previously completed a Phase 2 study of multi-tablet EB613 in 161 patients with postmenopausal osteoporosis that met primary and secondary endpoints.

EB613 is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. Currently approved anabolic therapies including Forteo, Tymlos, and Evenity require daily or monthly injections.

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