Entera Bio Ltd. recently announced it will present new clinical data from its Phase 2 trial of EB613 at the upcoming North American Menopause Society (NAMS) 2025 Annual Meeting, taking place October 21–25, 2025, in Orlando, FL. This will mark Entera’s first presentation at NAMS.

The presentation will showcase new Phase 2 data from EB613 in early postmenopausal women with low bone mass or osteoporosis, examining bone mineral density outcomes over six months. By focusing on this population – a stage where women are at rising risk but few receive anabolic therapy – this analysis will examine the potential role of EB613 earlier in the treatment journey, where injectable options remain underutilized.

“Anabolic therapies remain significantly underutilized despite their proven ability to rebuild bone, largely because they are only available as injections,” said Miranda Toledano, Chief Executive Officer of Entera. “By delivering the first oral anabolic tablet, EB613 has the potential to move treatment earlier in the care continuum and broaden access for the over 200 million women worldwide living with osteoporosis. At NAMS, we will present new data examining the timing of intervention in postmenopausal women – an important clinical and market question.”

Presentation Details

• Conference: North American Menopause Society (NAMS) 2025 Annual Meeting
• Title: 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
• Presentation Number: P-66
• Session Title: Poster Presentation
• Session Date/Time: Thursday, October, 23, 2025, 06:15 PM – 07:15 PM
• Place: Windemere Exhibit Hall

Substantial evidence supports the efficacy of anabolic treatments over anti-resorptive drugs for lowering fracture risk in osteoporosis patients. However, all available anabolic therapies are administered by subcutaneous (SC) injection and used in a minority of eligible patients. EB613 (oral PTH (1-34)), is being developed as the first oral, once-daily anabolic tablet treatment for osteoporosis. EB613 completed a phase 2, 6-month, 161-patient, placebo-controlled study that met all biomarker and BMD endpoints without significant safety concerns in women with postmenopausal osteoporosis or low BMD (JBMR 2024). EB613 produced rapid dose-proportional increases in biochemical markers of bone formation, reductions in markers of bone resorption, and increased lumbar spine, total hip, and femoral neck BMD.

Entera is a clinical stage company focused on developing oral peptide and protein replacement therapies for significant unmet medical needs where an oral tablet form holds the potential to transform the standard of care. The Company leverages on a disruptive and proprietary technology platform (N-Tab™) and its pipeline of first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. The Company’s most advanced product candidate, EB613 (oral PTH(1-34), teriparatide), is being developed as the first oral, osteoanabolic (bone building) once-daily tablet treatment for post-menopausal women with low BMD and high-risk osteoporosis. A placebo-controlled, dose-ranging Phase 2 study of EB613 tablets (n= 161) met primary (PD/bone turnover biomarker) and secondary endpoints (BMD). The EB612 program is being developed as the first oral PTH(1-34) tablet peptide replacement therapy for hypoparathyroidism. Entera is also developing the first oral oxyntomodulin, a dual targeted GLP1/glucagon peptide, in tablet form for the treatment of obesity and metabolic syndromes; and first oral GLP-2 peptide as an injection-free alternative for patients suffering from rare malabsorption conditions such as short bowel syndrome in collaboration with OPKO Health. For more information on Entera Bio, visit www.enterabio.com.