EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY Accepted for Oral Presentation at World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases
Entera Bio (NASDAQ: ENTX) announced that two abstracts related to EB613, their oral PTH(1-34) tablet treatment for post-menopausal osteoporosis, have been accepted for presentation at the WCO-IOF-ESCEO congress in Rome (April 10-13, 2025). The presentations will focus on the effects of EB613 on trabecular and cortical bone using 3D-DXA, and its impact on bone modeling versus remodeling.
In a Phase 2 placebo-controlled study, EB613 demonstrated rapid onset and significant BMD increases across all skeletal sites over 6 months, along with increased bone formation (P1NP) and reduced bone resorption (CTX). The treatment is being developed as the first once-daily oral anabolic therapy for high-risk post-menopausal women with osteoporosis, targeting a condition that affects an estimated 200 million women globally.
Entera Bio (NASDAQ: ENTX) ha annunciato che due abstract relativi a EB613, il loro trattamento orale con tablet di PTH(1-34) per l'osteoporosi post-menopausale, sono stati accettati per la presentazione al congresso WCO-IOF-ESCEO a Roma (10-13 aprile 2025). Le presentazioni si concentreranno sugli effetti di EB613 sull'osso trabecolare e corticale utilizzando 3D-DXA, e sul suo impatto sulla modellazione e rimodellamento osseo.
In uno studio di fase 2 controllato con placebo, EB613 ha dimostrato un rapido inizio d'azione e significativi aumenti della BMD in tutti i siti scheletrici nel corso di 6 mesi, insieme a un aumento della formazione ossea (P1NP) e una riduzione della riassorbimento osseo (CTX). Il trattamento è in fase di sviluppo come la prima terapia anabolizzante orale da assumere una volta al giorno per donne post-menopausali ad alto rischio con osteoporosi, mirando a una condizione che colpisce circa 200 milioni di donne a livello globale.
Entera Bio (NASDAQ: ENTX) anunció que dos resúmenes relacionados con EB613, su tratamiento oral con tabletas de PTH(1-34) para la osteoporosis posmenopáusica, han sido aceptados para presentación en el congreso WCO-IOF-ESCEO en Roma (10-13 de abril de 2025). Las presentaciones se centrarán en los efectos de EB613 sobre el hueso trabecular y cortical utilizando 3D-DXA, y su impacto en la modelación frente al remodelado óseo.
En un estudio de fase 2 controlado con placebo, EB613 demostró un inicio rápido y aumentos significativos en la DMO en todos los sitios esqueléticos durante 6 meses, junto con un aumento en la formación ósea (P1NP) y una reducción en la resorción ósea (CTX). El tratamiento se está desarrollando como la primera terapia anabólica oral de una vez al día para mujeres posmenopáusicas de alto riesgo con osteoporosis, enfocándose en una condición que afecta a aproximadamente 200 millones de mujeres en todo el mundo.
Entera Bio (NASDAQ: ENTX)는 EB613에 관한 두 개의 초록이 로마에서 열리는 WCO-IOF-ESCEO 회의(2025년 4월 10-13일)에서 발표되었다고 발표했습니다. 발표는 3D-DXA를 사용하여 EB613이 해면골과 피질골에 미치는 영향과 뼈 모델링과 리모델링에 대한 영향을 중점적으로 다룰 것입니다.
2상 위약 대조 연구에서, EB613는 6개월 동안 모든 골격 부위에서 BMD의 급속한 증가와 유의미한 증가를 보여주었으며, 뼈 형성(P1NP)의 증가와 뼈 재흡수(CTX)의 감소가 동반되었습니다. 이 치료는 고위험 폐경 후 여성의 골다공증을 위한 최초의 하루 한 번 복용하는 경구 아나볼릭 치료제로 개발되고 있으며, 전 세계적으로 약 2억 명의 여성에게 영향을 미치는 질환을 목표로 하고 있습니다.
Entera Bio (NASDAQ: ENTX) a annoncé que deux résumés liés à EB613, leur traitement oral sous forme de comprimés de PTH(1-34) pour l'ostéoporose post-ménopausique, ont été acceptés pour présentation au congrès WCO-IOF-ESCEO à Rome (10-13 avril 2025). Les présentations se concentreront sur les effets d'EB613 sur l'os trabéculaire et cortical à l'aide de la 3D-DXA, ainsi que sur son impact sur la modélisation par rapport au remodelage osseux.
Dans une étude de phase 2 contrôlée par placebo, EB613 a démontré un début d'action rapide et des augmentations significatives de la DMO sur tous les sites squelettiques sur une période de 6 mois, ainsi qu'une augmentation de la formation osseuse (P1NP) et une réduction de la résorption osseuse (CTX). Ce traitement est en cours de développement comme la première thérapie anabolique orale à prendre une fois par jour pour les femmes post-ménopausiques à haut risque souffrant d'ostéoporose, ciblant une condition qui touche environ 200 millions de femmes dans le monde.
Entera Bio (NASDAQ: ENTX) gab bekannt, dass zwei Abstracts zu EB613, ihrer oralen PTH(1-34) Tablettenbehandlung für postmenopausale Osteoporose, zur Präsentation auf dem WCO-IOF-ESCEO-Kongress in Rom (10.-13. April 2025) angenommen wurden. Die Präsentationen werden sich auf die Auswirkungen von EB613 auf trabekuläres und kortikales Knochengewebe unter Verwendung von 3D-DXA konzentrieren und auf die Auswirkungen auf die Knochenmodellierung im Vergleich zur Knochenremodellierung eingehen.
In einer Phase-2-Studie mit Placebo-Kontrolle zeigte EB613 einen schnellen Wirkungseintritt und signifikante BMD-Zuwächse an allen Skelettstellen über 6 Monate hinweg, zusammen mit erhöhten Knochenbildungsraten (P1NP) und reduzierter Knochenresorption (CTX). Die Behandlung wird als erste einmal täglich einzunehmende orale anabole Therapie für hochrisiko-postmenopausale Frauen mit Osteoporose entwickelt, die eine Erkrankung anvisiert, die schätzungsweise 200 Millionen Frauen weltweit betrifft.
- Phase 2 study showed positive results with increased BMD across all skeletal sites
- Demonstrated both increased bone formation and reduced bone resorption
- First-in-class potential as once-daily oral anabolic treatment
- None.
Insights
The acceptance of two EB613 abstracts for presentation at the prestigious WCO-IOF-ESCEO congress marks a significant milestone in the development of oral PTH(1-34) therapy. The post-hoc analysis using 3D-DXA technology is particularly noteworthy, as it provides detailed insights into both trabecular and cortical bone effects - a important differentiation point for bone-forming therapies. This advanced imaging technique offers a more comprehensive understanding of bone microarchitecture changes compared to traditional DXA scans.
The Phase 2 results demonstrate several key advantages:
- Rapid onset of action with BMD improvements across multiple skeletal sites
- Positive modulation of both P1NP (bone formation) and CTX (bone resorption) markers
- Once-daily oral administration format that could significantly improve treatment accessibility
The market opportunity is substantial, with an estimated 200 million women affected by postmenopausal osteoporosis globally. Current injectable anabolic treatments, while effective, face significant adoption barriers. An oral alternative could dramatically expand the addressable market, particularly for high-risk patients who require early intervention but are resistant to injectable therapies.
The presentation of pharmacokinetic (PK) data relating to bone modeling versus remodeling is particularly intriguing, as it could provide important insights into the mechanism of action and potentially support the drug's differentiation in the market. The development of EB613 as a first-line 'boost' treatment, followed by antiresorptive therapy, aligns well with current treatment paradigms while potentially improving patient compliance and outcomes.
JERUSALEM , Feb. 19, 2025 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX), (“Entera” or the “Company”) a leader in the development of oral peptide and protein replacement therapies in tablet form, today announced that the World Congress on Osteoporosis, Osteoarthritis and Musculoskeletal Diseases (WCO-IOF-ESCEO) Scientific Programme Committee has accepted both submitted abstracts related to EB613 for presentation at the WCO-IOF-ESCEO congress. The congress will take place at the Roma Convention Center, Rome, Italy from April 10 to April 13, 2025.
EB613 is being developed as the first once-daily oral anabolic (bone forming) PTH(1-34) tablet treatment to support earlier osteoanabolic intervention, for high-risk post-menopausal women with osteoporosis. In a Placebo-controlled Phase 2 study, 6 months of EB613 treatment demonstrated fast onset of action and robust increases in BMD at all skeletal sites. Further, EB613 induced increases in bone formation (P1NP) and suppression of bone resorption (CTX).
“EFFECTS OF EB613 TABLETS [ORAL PTH(1-34)] ON TRABECULAR AND CORTICAL BONE USING 3D-DXA: POST-HOC RESULTS FROM PHASE 2 STUDY” will be presented as an Oral Presentation Friday April 11 at 10:00 GMT in the Auditorium A.
“EB613 TABLET TREATMENT [ORAL PTH(1-34)] – DOES PK DRIVE BONE MODELING VERSUS BONE REMODELING?” will be presented as a Poster Presentation Friday April 11th – Sunday April 13th 2025.
“We thank our distinguished authors and are looking forward to sharing further mechanistic insights on EB613 with the thousands of top researchers and healthcare professionals who attend WCO-IOF-ESCEO,” said Miranda Toledano, Chief Executive Officer of Entera.
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 approximately 1 in 5 adults will die within the year following a hip fracture. Post menopausal osteoporosis afflicts more women than cancer and cardiovascular disease and is a serious health concern for an estimated 200 million women globally.
EB613 is intended to provide an anabolic ‘boost’ to strengthen skeletal microarchitecture and induce rapid BMD gains, followed by consolidation with an antiresorptive agent. “Available injectable anabolic treatments, while efficacious and recommended across medical guidelines, unfortunately do not provide a viable solution for most patients with high-risk osteoporosis requiring an anabolic intervention. Our EB613 program is being developed to address the treatment chasm in current osteoporosis care and hopefully present a treatment for the majority of patients to adequately manage their bone health with a simple once daily tablet treatment,” Said Toledano.
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 includes five differentiated, 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)), 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). Entera is preparing to initiate a Phase 3 registrational study for EB613 pursuant to the FDA’s qualification of a quantitative BMD endpoint. 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 first oral GLP-2 peptide tablet 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 or follow us on LinkedIn, Twitter, Facebook, Instagram.
Cautionary Statement Regarding Forward Looking Statements
Various statements in this presentation are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements (other than statements of historical facts) in this presentation regarding our prospects, plans, financial position, business strategy and expected financial and operational results may constitute forward-looking statements. Words such as, but not limited to, “anticipate,” “believe,” “can,” “could,” “expect,” “estimate,” “design,” “goal,” “intend,” “may,” “might,” “objective,” “plan,” “predict,” “project,” “target,” “likely,” “should,” “will,” and “would,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Forward-looking statements should not be read as a guarantee of future performance or results and may not be accurate indications of when such performance or results will be achieved.
Important factors that could cause actual results to differ materially from those reflected in Entera’s forward-looking statements include, among others: changes in the interpretation of clinical data; results of our clinical trials; the FDA’s interpretation and review of our results from and analysis of our clinical trials; unexpected changes in our ongoing and planned preclinical development and clinical trials, the timing of and our ability to make regulatory filings and obtain and maintain regulatory approvals for our product candidates; the potential disruption and delay of manufacturing supply chains; loss of available workforce resources, either by Entera or its collaboration and laboratory partners; impacts to research and development or clinical activities that Entera may be contractually obligated to provide; overall regulatory timelines; the size and growth of the potential markets for our product candidates; the scope, progress and costs of developing Entera’s product candidates; Entera’s reliance on third parties to conduct its clinical trials; Entera’s ability to establish and maintain development and commercialization collaborations; Entera’s operation as a development stage company with limited operating history; Entera’s competitive position with respect to other products on the market or in development for the treatment of osteoporosis, hypoparathyroidism, short bowel syndrome, obesity, metabolic conditions and other disease categories it pursues; Entera’s ability to continue as a going concern absent access to sources of liquidity; Entera’s ability to obtain and maintain regulatory approval for any of its product candidates; Entera’s ability to comply with Nasdaq’s minimum listing standards and other matters related to compliance with the requirements of being a public company in the United States; Entera’s intellectual property position and its ability to protect its intellectual property; and other factors that are described in the “Cautionary Statement Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of Entera’s most recent Annual Report on Form 10-K filed with the SEC, as well as Entera’s subsequently filed Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. There can be no assurance that the actual results or developments anticipated by Entera will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera cautions investors not to rely on the forward-looking statements Entera makes in this presentation. The information in this presentation is provided only as of the date of this presentation, and Entera undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, except to the extent required by law.
FAQ
What were the key results from ENTX's EB613 Phase 2 study?
When will ENTX present the EB613 study results at WCO-IOF-ESCEO 2025?
What is the market potential for ENTX's EB613 osteoporosis treatment?
How does ENTX's EB613 differ from existing osteoporosis treatments?
