Entera Bio Releases New Phase 2 Data At NAMS 2025 Showing That EB613, An Oral PTH[1-34] Therapy, Consistently Increased Bone Mineral Density In Both Early Postmenopausal Women And Those 10 Years Post-Menopause

Author: Benzinga Newsdesk | October 23, 2025 07:58am

Consistency of BMD gains presented at NAMS 2025 demonstrate EB613's efficacy in both young postmenopausal women and in women 10 years post-menopause

Data further support EB613 potential as a first-in-class oral anabolic treatment option that could dramatically expand patient access to bone-building therapy

Entera Plans to Initiate Global Registrational Phase 3 Study Following July 2025 FDA Concurrence

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.

"These findings demonstrate that EB613 produces significant BMD improvements in early postmenopausal women, a critical population for fracture prevention," said Steven R. Goldstein, MD, Professor of Obstetrics and Gynecology at NYU School of Medicine and member of Entera's Clinical and Scientific Advisory Board, who presented the data at NAMS. "What's particularly significant is the consistency of response across different stages of menopause. The fact that we're seeing these results with an oral formulation addresses one of the most significant barriers in osteoporosis care, opening the door to introduce anabolic therapy earlier in the treatment journey, when injectable options are rarely used. This could be a game-changer for patient access and compliance."

Key Findings

In early postmenopausal women (≤10 years since last menstrual period), EB613 (n=8) versus placebo (n=19), statistically significant BMD increases were observed at six months:

• Lumbar spine: 3.1% increase vs placebo at six months (p=0.05), demonstrating significant bone density gains at a key fracture site.
• Total hip: 2.3% increase vs placebo (p=0.03), reflecting meaningful improvements in overall bone strength.
• Femoral neck: 2.0% increase, consistent with gains observed in later postmenopausal women.

These results were comparable to BMD improvements seen in women more than 10 years post-menopause, where EB613 increased femoral neck BMD by 3.2% (p=0.02) and lumbar spine BMD by 2.5% (p=0.08).

"EB613 has the potential to transform how osteoporosis is treated by bringing anabolic therapy into earlier stages of care, where it is rarely used today," said Miranda Toledano, Chief Executive Officer of Entera Bio. "By delivering bone-building therapy in a convenient oral tablet, we can broaden access for millions of postmenopausal women at risk of fracture and pioneer the first oral anabolic treatment option to address this critical unmet need.

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