Entera Bio presents clinical data from EB613 Phase 2 trial

Entera Bio (ENTX) reported new clinical data from a post-hoc analysis of its Phase 2 trial of EB613, at the 2025 North American Menopause Society Annual Meeting in a poster presentation titled “EB613 Increases BMD Over 6 Months in Early Postmenopausal Women with Low Bone Mass or Osteoporosis: A Phase 2 Randomized Trial.” EB613, Entera’s once-daily oral PTH 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 by producing significant and consistent gains in bone mineral density 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 Goldstein, MD, Professor of Obstetrics and Gynecology at NYU School of Medicine. “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, EB613 versus placebo, statistically significant BMD increases were observed at six months: Lumbar spine: 3.1% increase vs placebo at six months, demonstrating significant bone density gains at a key fracture site. Total hip: 2.3% increase vs placebo reflecting meaningful improvements in overall bone strength. Femoral neck: 2.0% increase, consistent with gains observed in later postmenopausal women.