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OPKO Health and Entera Bio Announce Abstract on PK/PD of Oral GLP-2 Tablet for the Treatment of Short Bowel Syndrome Selected for 2025 ESPEN Congress

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OPKO Health (NASDAQ: OPK) and Entera Bio announced their abstract on oral GLP-2 tablet for Short Bowel Syndrome (SBS) treatment has been selected for presentation at the 47th ESPEN Congress in Prague this September.

The research combines OPKO's proprietary long-acting GLP-2 agonist with Entera's N-Tab™ technology, aiming to provide an oral alternative to GATTEX® (teduglutide), which currently requires daily subcutaneous injections. The oral tablet format could potentially improve treatment compliance and enable more personalized care for SBS patients.

OPKO Health (NASDAQ: OPK) e Entera Bio hanno annunciato che il loro abstract riguardante una compressa orale di GLP-2 per il trattamento della Sindrome dell'Intestino Corto (SBS) è stato selezionato per la presentazione al 47° Congresso ESPEN che si terrà a Praga questo settembre.

La ricerca combina l'agonista GLP-2 a lunga durata d'azione proprietario di OPKO con la tecnologia N-Tab™ di Entera, con l'obiettivo di offrire un'alternativa orale a GATTEX® (teduglutide), che attualmente richiede iniezioni sottocutanee giornaliere. Il formato in compresse orali potrebbe migliorare l'aderenza al trattamento e consentire una cura più personalizzata per i pazienti con SBS.

OPKO Health (NASDAQ: OPK) y Entera Bio anunciaron que su resumen sobre una tableta oral de GLP-2 para el tratamiento del Síndrome del Intestino Corto (SBS) ha sido seleccionado para presentación en el 47º Congreso ESPEN que se celebrará en Praga este septiembre.

La investigación combina el agonista GLP-2 de acción prolongada patentado por OPKO con la tecnología N-Tab™ de Entera, con el objetivo de ofrecer una alternativa oral a GATTEX® (teduglutida), que actualmente requiere inyecciones subcutáneas diarias. El formato de tableta oral podría mejorar la adherencia al tratamiento y permitir una atención más personalizada para los pacientes con SBS.

OPKO Health (NASDAQ: OPK)Entera Bio단장 증후군(SBS) 치료를 위한 경구용 GLP-2 정제에 관한 초록이 오는 9월 프라하에서 열리는 제47회 ESPEN 학회에서 발표될 예정임을 발표했습니다.

이번 연구는 OPKO의 독점 장기 작용 GLP-2 작용제와 Entera의 N-Tab™ 기술을 결합하여 현재 매일 피하 주사가 필요한 GATTEX®(테두글루타이드)에 대한 경구 대안을 제공하는 것을 목표로 합니다. 경구 정제 형태는 치료 순응도를 높이고 SBS 환자에게 보다 맞춤화된 치료를 가능하게 할 수 있습니다.

OPKO Health (NASDAQ : OPK) et Entera Bio ont annoncé que leur résumé concernant un comprimé oral de GLP-2 pour le traitement du Syndrome de l'Intestin Court (SBS) a été sélectionné pour une présentation au 47e Congrès ESPEN qui se tiendra à Prague en septembre prochain.

Cette recherche combine l'agoniste GLP-2 à longue durée d'action propriétaire d'OPKO avec la technologie N-Tab™ d'Entera, visant à offrir une alternative orale à GATTEX® (téduglutide), qui nécessite actuellement des injections sous-cutanées quotidiennes. Le format comprimé oral pourrait améliorer l'observance du traitement et permettre une prise en charge plus personnalisée des patients atteints de SBS.

OPKO Health (NASDAQ: OPK) und Entera Bio haben bekannt gegeben, dass ihr Abstract über eine orale GLP-2 Tablette zur Behandlung des Kurzdarmsyndroms (SBS) für eine Präsentation auf dem 47. ESPEN Kongress im September in Prag ausgewählt wurde.

Die Forschung kombiniert den proprietären langwirksamen GLP-2-Agonisten von OPKO mit Enteras N-Tab™-Technologie, mit dem Ziel, eine orale Alternative zu GATTEX® (Teduglutid) zu bieten, das derzeit tägliche subkutane Injektionen erfordert. Das orale Tablettenformat könnte die Therapietreue verbessern und eine individuellere Versorgung von SBS-Patienten ermöglichen.

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MIAMI and JERUSALEM, July 08, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) (“OPKO”) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that their abstract “First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome” has been selected for a poster presentation at the 47th European Society for Clinical Nutrition & Metabolism (“ESPEN”) Congress, taking place September 13–16, 2025, in Prague, Czech Republic.

Abstract Title: First-in-Class Oral GLP-2 Analog for Treatment of Short Bowel Syndrome
Poster Viewing Date & Time: September 13, 2025, 3:30 - 4:00 p.m. local time & Welcome Reception
Poster Topic: Poster Session 1 - Liver and gastrointestinal tract
Location of Display: Forum Hall Foyer 3

The oral GLP-2 tablet program combines a proprietary long acting GLP-2 agonist developed by OPKO with Entera’s proprietary N-Tab™ technology for patients suffering from short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption. Currently, the only approved GLP-2 agonist, which is marketed under the brand GATTEX® (teduglutide), requires daily subcutaneous injections.

“Given the heterogeneity of patients with SBS and challenging compliance rates attributed to injectable GLP-2 therapy, we believe a daily tablet format may enable more personalized care of this peptide and individualize titration,” said Miranda Toledano, Entera Chief Executive Officer.

About Short Bowel Syndrome

Short bowel syndrome (SBS) is a rare and potentially life-threatening malabsorptive condition caused by a significant loss of functional bowel mass (secondary to congenital defects or disease-associated loss of absorption) or physical bowel mass (secondary to extensive intestinal resection). Approximately 30,000 patients across the US and EU are living with SBS, and current annual sales of GATTEX® (teduglutide), the only approved therapy for SBS, total roughly $800 million. SBS patients have a reduced ability to absorb nutrients and fluids and are at risk of malnutrition, unintended weight loss and additional symptoms due to the loss of essential vitamins and minerals1. SBS is the most common cause of chronic intestinal failure, accounting for approximately 75% of chronic intestinal failure cases in adults and 50% of such events in children.2

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 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)), 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 the 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.

About OPKO Health

OPKO Health is a multinational biopharmaceutical and diagnostics company that seeks to establish industry-leading positions in large, rapidly growing markets by leveraging its discovery, development and commercialization expertise, and its novel and proprietary technologies. For more information, visit www.opko.com.

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 and OPKO’s forward-looking statements include, among others: results of our clinical trials; the anticipated benefits of an oral tablet for the treatment of SBS; and other factors that are described in the “Cautionary Statements Regarding Forward-Looking Statements,” “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of each of Entera’s and OPKO’s most recent Annual Reports on Form 10-K filed with the SEC, as well as the companies’ respective 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 and OPKO will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, Entera or OPKO, as applicable. Therefore, no assurance can be given that the outcomes stated or implied in such forward-looking statements and estimates will be achieved. Entera and OPKO caution investors not to rely on the forward-looking statements made in this press release. The information in this press release is provided only as of the date of this press release, and neither Entera nor OPKO undertakes any 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.

Contacts:

Entera Bio
Miranda Toledano
Chief Executive Officer
miranda@enterabio.com  

OPKO Health
Alliance Advisors IR
Yvonne Briggs, 310-691-7100
ybriggs@allianceadvisors.com 
or 
Bruce Voss, 310-691-7100 
bvoss@allianceadvisors.com

1 https://rarediseases.org/rare-diseases/short-bowel-syndrome/
2 Zhu C, Li Y. An updated overview of glucagon-like peptide-2 analog trophic therapy for short bowel syndrome in adults. J Int Med Res. 2022 Mar;50(3):3000605221086145. doi: 10.1177/03000605221086145. PMID: 35343263; PMCID: PMC8966062.


FAQ

When will OPKO Health present their oral GLP-2 tablet research at ESPEN Congress 2025?

The poster presentation will take place on September 13, 2025, from 3:30 - 4:00 p.m. local time during the Welcome Reception at Forum Hall Foyer 3 in Prague.

What is the advantage of OPKO's oral GLP-2 tablet over current SBS treatments?

The oral tablet format could provide an alternative to GATTEX® (teduglutide), which requires daily subcutaneous injections, potentially enabling more personalized care and improved treatment compliance for SBS patients.

What technologies are combined in OPKO's oral GLP-2 tablet for Short Bowel Syndrome?

The treatment combines OPKO's proprietary long-acting GLP-2 agonist with Entera's proprietary N-Tab™ technology.

What conditions could OPKO's oral GLP-2 tablet potentially treat?

The treatment is being developed for short bowel syndrome and additional disorders involving gastrointestinal mucosal inflammation and nutrient malabsorption.
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