WILMINGTON, Del. — October 13, 2026
Entera Bio Ltd. (NASDAQ: ENTX), a clinical-stage company developing oral peptide therapies, announced new Phase 2 findings for EB613, its investigational oral parathyroid hormone PTH(1-34) tablet, in postmenopausal women with osteoporosis. Presented at the American Society for Bone and Mineral Research (ASBMR) 2026 Annual Meeting in Boston, Massachusetts, the findings showed greater bone mineral density (BMD) gains and stronger bone-building effects among women with osteoporosis than among participants with less severe bone loss. The company also presented the proposed design of its registrational Phase 3 study, which is intended to evaluate EB613 in postmenopausal women at increased risk of fracture. These results support further investigation of an oral anabolic treatment that could offer an alternative to injectable bone-building therapies.
Phase 2 Analysis Shows Greater Bone Density Gains
The findings came from a post-hoc sensitivity analysis of a Phase 2 study that randomized 161 postmenopausal women with low bone mass or osteoporosis to placebo or one of four EB613 dose levels for six months. The analysis focused on EB613 at 2.5 mg once daily and compared outcomes according to participants’ baseline bone density T-scores. Among women with osteoporosis, defined by a T-score of −2.5 or lower, placebo-adjusted BMD increases at six months reached 4.23% at the total hip among six participants and 4.22% at the lumbar spine among nine participants. In comparison, women with T-scores above −2.5 recorded placebo-adjusted increases of 1.02% at the total hip among 15 participants and 1.59% at the lumbar spine among 12 participants. Across all 21 participants receiving EB613 2.5 mg, the corresponding pooled increases were 1.84% at the total hip and 2.72% at the lumbar spine. The analysis also found that changes in P1NP, a marker of bone formation, and CTX, a marker of bone resorption, were somewhat larger and more persistent among women with osteoporosis. Because the subgroup analysis was exploratory and involved small participant numbers, the findings are hypothesis-generating rather than definitive evidence of superior treatment effects.
Phase 3 Trial to Enroll Approximately 900 Women
Entera presented the proposed design of a multinational, randomized, double-blind, placebo-controlled Phase 3 trial intended to assess EB613’s safety and efficacy in postmenopausal women with osteoporosis. The study is planned to enroll approximately 900 participants, randomized in a 2:1 ratio to receive EB613, with about 600 participants, or placebo, with about 300 participants. Eligible women will be 50–90 years old, at least five years beyond their last menstrual period, and have osteoporosis diagnosed by dual-energy X-ray absorptiometry (DXA), with a BMD T-score of −2.50 or lower at the lumbar spine, total hip or femoral neck. The primary efficacy assessment will measure the change in total hip BMD at Month 12 compared with placebo. Secondary endpoints include lumbar spine and femoral neck BMD at Month 12, as well as changes in total hip, lumbar spine and femoral neck BMD at Months 3 and 6. Safety monitoring will include adverse events, vital signs, physical examinations and clinical laboratory tests. Pharmacokinetics following oral administration will be assessed in subsets of participants through population-PK and full-PK substudies. Participants completing the initial 12-month period may enter an extension study through Month 24 to assess longer-term safety and durability of response.
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Oral Anabolic Therapy Targets Unmet Osteoporosis Needs
EB613 is being developed as a once-daily oral anabolic treatment designed to stimulate bone formation. Entera believes an oral tablet could help address barriers associated with daily injections and support treatment strategies that prioritize anabolic therapy for appropriate patients at high fracture risk. The company’s clinical rationale is based on the potential to increase BMD and improve skeletal strength, while the Phase 3 program is intended to establish whether the candidate can demonstrate adequate safety and efficacy for potential registration. The new subgroup findings are particularly relevant to the planned Phase 3 population because the larger BMD gains were observed in participants whose baseline T-scores met the osteoporosis threshold. However, the reported analysis does not establish that EB613 reduces fractures, and the small subgroup sizes limit the conclusions that can be drawn. The planned Phase 3 study will provide a larger, controlled assessment of BMD outcomes and safety over 12 months, with a potential extension to 24 months. Entera’s broader pipeline also includes oral peptide candidates for hypoparathyroidism, obesity and metabolic disorders, and rare malabsorption conditions. For EB613, the next important milestone is the clinical evaluation of its proposed benefits in a larger osteoporosis population.
Source::Entera Bio, press release
