Announcement • Jun 15
Entera Bio Ltd. Reports Comparative Phase 1 Data Evaluating Single-Tablet And Multi-Tablet Oral EB613 With Forteo
Entera Bio Ltd. reported comparative Phase 1 data evaluating single-tablet and multi-tablet oral EB613 with Forteo (teriparatide SC injection, Eli Lilly). The oral presentation '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 presented as a Late-Breaking Oral Presentation at ENDO 2026, the annual meeting of the Endocrine Society, taking place in Chicago, Illinois. Substantial evidence supports the use of anabolic (bone-building) therapies over anti-resorptive drugs for rapidly lowering fracture risk in osteoporosis patients at high risk of fractures. However, the three approved agents (Forteo, Tymlos, Evenity) require daily or monthly injections and are used in only a minority of eligible patients. Entera is developing EB613 as the first oral, anabolic tablet treatment for patients with osteoporosis. In the Phase 1 (NCT05965167) study, a cohort of 15 healthy participants each received single-tablet EB613, multi-tablet oral EB613, and subcutaneous Forteo at doses ranging from 1 mg to 3 mg, to evaluate and compare the three treatments’ pharmacokinetic (PK) and pharmacodynamic (PD) profiles. Key findings included: Single tablet EB613 showed a PK profile comparable to multi-tablet EB613, with similar Cmax, Tmax, and total systemic exposure (AUC). The AUC of single tablet and multi-tablet EB613 was comparable with Forteo, exhibiting a slightly shorter duration of exposure, which is consistent with prior Phase 1 studies. Comparable calcemic effects (serum calcium) and consistent suppression of endogenous PTH(1-84) were shown 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. 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. Substantial evidence supports the efficacy of anabolic therapies over bisphosphonates for lowering fracture risk in osteoporosis patients at high risk. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. Entera’s EB613 program (oral PTH(1-34), teriparatide) is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 completed a Phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increases in lumbar spine, total hip, and femoral neck BMD. The effects of EB613 on trabecular and cortical bone using 3D-DXA showed increases with EB613 compared with placebo in a variety of indices, including integral volumetric BMD and trabecular volumetric BMD, cortical thickness, and cortical surface BMD. Mechanistically, the findings suggest that bone strengthening and fracture resistance may occur rapidly with EB613. Furthermore, the data is consistent with that of published subcutaneous teriparatide at the 6-month time point.
