Entera Bio Presents New Clinical Data From Phase 2 Study Of EB613 At 2025 North American Menopause Society Annual Meeting; Intends To Initiate Global Registrational Phase 3 Trial After July 2025 FDA Concurrence

Author: Benzinga Newsdesk | October 23, 2025 08:05am

Entera Bio Ltd. (NASDAQ:ENTX), a leader in the development of oral peptide and protein replacement therapies, today reported new clinical data from a post-hoc analysis of its Phase 2 trial of EB613, at the 2025 North American Menopause Society (NAMS) Annual Meeting in a poster presentation titled "EB613 (Oral PTH[1-34] Tablets) Increases BMD Over 6 Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial (P-66)."

EB613, Entera's once-daily oral PTH(1-34) anabolic tablet, is being developed as the first oral bone-building therapy for postmenopausal women at high risk for fracture. Despite clear clinical guidelines recommending anabolic agents for their superior benefits, these therapies remain significantly underutilized due to injectable administration and high costs. In this new analysis of the Phase 2 trial, EB613 demonstrated its effect at the 2.5 mg dose (the regimen selected for the upcoming Phase 3 study) by producing significant and consistent gains in bone mineral density (BMD) at the spine, femoral neck and hip in women within 10 years of menopause, with improvements comparable to those observed in women more than 10 years post-menopause.

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