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Entera Presents Markedly Enhanced Anabolic Effects of EB613 (First-in-Class Oral PTH(1-34) Tablet) in Postmenopausal Women with Osteoporosis at High Risk of Fracture and Showcases Phase 3 Design at ASBMR 2026 Annual Meeting

Globe Newswire•13/10/2026•07:00 ET
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Key Highlights

  • ➤EB613 produced 4.23% total-hip and 4.22% lumbar-spine BMD gains
  • ➤Phase 3 plans approximately 900 women with osteoporosis randomized 2:1
  • ➤Phase 3 evaluates Month 12 total-hip BMD versus placebo
  • ➤EB613 showed larger, more persistent bone-turnover marker changes in osteoporosis

Expert Statements

Felicia Cosman, Professor of Medicine at Columbia University

“As we have learned about the importance of treatment sequence, our therapeutic strategies have evolved toward using anabolic therapy first to optimize osteoporosis patient management. Multiple studies illustrate the superiority of anabolic over anti-resorptive drugs at reducing fractures, building BMD, and restoring skeletal microarchitecture. Several major guidelines support this approach. Nonetheless, daily injections remain a barrier for both patients and prescribers. EB613 is uniquely positioned to be the first oral anabolic tablet for the treatment of osteoporosis. The oral tablet will allow us to overcome barriers to implementing the anabolic-first strategy. Our 6 month clinical data with EB613 show rapid stimulation of bone formation and robust early BMD accrual, especially in patients who start with lower BMD and who need the largest gains.”

Rachel B Wagman, Chief Clinical Advisor to Entera

“The evidence package to date has laid the foundation for our Phase 3 plans. The opportunity to evaluate the safety and efficacy of EB613 for product registration has generated excitement among clinical investigators and patients. As the first oral anabolic agent in late-stage clinical development, EB613 offers the potential to evolve the treatment paradigm to help address important needs of patients.”

Miranda Toledano, Chief Executive Officer of Entera

“Although our Phase 2 data showed positive responses in postmenopausal women with low bone mass (osteopenia) as well as women with osteoporosis by T-score, this analysis further derisks our thesis for the population we intend to enroll in our Phase 3 study.”

Post-hoc Phase 2 data show greater bone mineral density (BMD) gains and anabolic effect with EB613 in postmenopausal women with baseline T-scores of ≤-2.5 (osteoporosis) versus T-scores of >-2.5 (osteopenia)

These findings support the potential benefit of EB613 in postmenopausal women with osteoporosis at high risk for fracture - consistent with the study population to be enrolled in Entera’s Phase 3 study

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