אנטרה ביו מציגה השפעות חיוביות של EB613 הן על עצם טרבקולרית והן על עצם קליפת המוח בנשים לאחר גיל המעבר עם אוסטאופורוזיס ב-ASBMR 2025
ירושלים,
8 בספטמבר 2025 (GLOBE NEWSWIRE) –
אנטרה ביו Entera Bio Ltd. (נאסד"ק: ENTX), מובילה בפיתוח פפטידים וחלבונים טיפוליים
הניתנים דרך הפה, הודיעה היום על נתונים שנבחרו להצגה במפגש השנתי של האגודה
האמריקנית לחקר עצמות ומינרלים ((“ASBMR” 2025 בסיאטל, וושינגטון, עבור התוכנית
המובילה שלה EB613 שנמצאת בשלב מאוחר של פיתוח קליני לנשים
לאחר גיל המעבר עם אוסטאופורוזיס. ההערכה היא כי 50 אחוז מהנשים ו-20 אחוז מהגברים
מעל גיל 50 נמצאים בסיכון לשברים שבריריים ופחות מ-30% מהחולים מטופלים כראוי
בתרופות זמינות.
EB613
Demonstrates Significant Effects on Both Trabecular and Cortical Bone
Compartments After Just 6 Months of Treatment in Phase 2 Study; Cortical
Improvements Comparable to Injectable Teriparatide and Abaloparatide
Company
Plans to Initiate Global Registrational Phase 3 Study Following July 2025 FDA
Concurrence
Entera also
Presented Promising Pharmacokinetic Data for Next-Gen EB613 Single Tablet
Candidate as Potential Future Franchise Extension
JERUSALEM,
Sept. 08, 2025 (GLOBE NEWSWIRE) –
Entera Bio
Ltd. (NASDAQ: ENTX), a leader in the development of oral peptides and proteins
replacement therapies, today announced data selected for presentation at the
American Society for Bone and Mineral Research (“ASBMR”) 2025 Annual Meeting in
Seattle, Washington, for its lead program EB613 which is in late stage clinical
development for post-menopausal women with osteoporosis. It is estimated that
50 percent of women and 20 percent of men over the age of 50 are at risk of a
fragility fractures and less than 30% of patients are adequately treated with
available medications.
"The
data presented at ASBMR this year marks important progress for our EB613
program," said Miranda Toledano, Chief Executive Officer of Entera.
"Available injectable anabolic treatments, while efficacious and
recommended across medical guidelines, are only accessible to a minority of
patients globally. Our EB613 program is being developed to address the
treatment chasm in osteoporosis care with a viable anabolic treatment in tablet
format for patients to adequately protect their bones.”
In the oral
presentation titled "Effects of EB613 Tablets [Oral PTH(1-34)] on
Trabecular and Cortical Bone Using 3D-DXA: Results from Phase 2 Study," Rachel
B. Wagman, MD presented data using 3D-DXA modelling in a post-hoc analysis of
EB613 Phase 2 results to look at the treatment’s impact on trabecular and
cortical bone. After 6 months of treatment, EB613 2.5 mg demonstrated
significant increases in both trabecular and cortical bone parameters as
compared with placebo. Mechanistically, the findings suggest that bone
strengthening, and fracture resistance may occur rapidly with EB613.
"The
improvements across multiple parameters, including integral volumetric BMD,
cortical thickness, and cortical surface BMD, suggest that there is an early
strengthening effect with EB613 and a deterioration with placebo,” said Dr.
Wagman. “We look forward to studying the safety and efficacy of EB613 in Phase
3.”
- Increases in
integral volumetric BMD of the TH and FN by 1.7% (p<0.08) and 2.6%
(p<0.03), respectively
- Increases in FN
trabecular volumetric BMD by 4.4% vs. placebo (p<0.03) and increases in
TH trabecular volumetric BMD by 2.8% (p=0.05 vs. baseline, NS compared
with placebo)
- Increases in
cortical thickness at the TH and FN by 1.3% (p=0.04) and 1.7% (p=0.056),
respectively Improvements in cortical surface BMD at the TH and FN by 1.5%
and 2.1%, respectively (both p<0.05)
In a poster
presentation titled "Advancing Oral Anabolic Treatments for
Osteoporosis: Pre-Clinical Data for Next-Gen EB613 Tablet Utilizing N-Tab™
Proprietary Technology," Entera presented preclinical data for its
Next-Gen EB613 candidate. In a cross-over pharmacokinetic study in minipigs, a
single 1.5 mg Next-Gen EB613 tablet demonstrated comparable PK to the current
formulation of EB613, with identical AUClast and Tmax values (1.2 min*ng/ml and
20 min, respectively), and comparable Cmax. A Phase 1 clinical trial of
Next-Gen EB613 is planned to begin in late 2025.
About EB613
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.
About
Entera Bio
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 .
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