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 osteoporosis subgroup showed placebo-adjusted BMD gains of 4.23% at total hip and 4.22% at lumbar spine
- ➤Phase 3 trial plans approximately 900 postmenopausal women randomized 2:1 to EB613 or placebo
- ➤Phase 3 primary endpoint evaluates Month 12 total hip BMD change versus placebo
- ➤Participants completing 12 months may enter an extension assessing EB613 safety and durability through Month 24
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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