OPKO Health and Entera Bio Abstract for First-in-Class Dual GLP-1/Glucagon Tablet Candidate for Patients with Obesity and Metabolic Disorders Selected for Presentation at the ENDO 2025 Annual Meeting
OPKO Health (NASDAQ: OPK) and Entera Bio announced their abstract for oral OPK-88006, a novel dual GLP-1/glucagon peptide treatment, has been selected for presentation at ENDO 2025 in San Francisco. The treatment is being developed as both a once-daily tablet and a weekly subcutaneous injection for patients with obesity and metabolic disorders.
The oral program combines OPKO's long-acting oxyntomodulin analog with Entera's N-Tab™ technology. The companies plan to file an IND application with the FDA later in 2025, followed by Phase 1 clinical studies. The presentation will showcase new pharmacologic and pharmacokinetic in vivo data at the conference on July 13, 2025.
OPKO Health (NASDAQ: OPK) e Entera Bio hanno annunciato che il loro abstract sull'OPK-88006 orale, un nuovo trattamento duale peptidico GLP-1/glucagone, è stato selezionato per una presentazione orale al ENDO 2025 a San Francisco. Il trattamento è in fase di sviluppo sia come compressa da assumere una volta al giorno sia come iniezione sottocutanea settimanale per pazienti con obesità e disturbi metabolici.
Il programma orale combina l'analogo a lunga durata d'azione dell'oxyntomodulina di OPKO con la tecnologia N-Tab™ di Entera. Le aziende prevedono di presentare una domanda IND alla FDA entro la fine del 2025, seguita da studi clinici di Fase 1. La presentazione mostrerà nuovi dati farmacologici e farmacocinetici in vivo durante la conferenza del 13 luglio 2025.
OPKO Health (NASDAQ: OPK) y Entera Bio anunciaron que su resumen sobre OPK-88006 oral, un novedoso tratamiento dual peptídico GLP-1/glucagón, ha sido seleccionado para presentación oral en ENDO 2025 en San Francisco. El tratamiento se está desarrollando tanto como una tableta diaria como una inyección subcutánea semanal para pacientes con obesidad y trastornos metabólicos.
El programa oral combina el análogo de oxintomodulina de acción prolongada de OPKO con la tecnología N-Tab™ de Entera. Las compañías planean presentar una solicitud IND ante la FDA a finales de 2025, seguida de estudios clínicos de Fase 1. La presentación mostrará nuevos datos farmacológicos y farmacocinéticos in vivo en la conferencia del 13 de julio de 2025.
OPKO Health (NASDAQ: OPK)와 Entera Bio는 새로운 이중 작용 GLP-1/글루카곤 펩타이드 치료제인 경구용 OPK-88006에 대한 초록이 샌프란시스코에서 열리는 ENDO 2025에서 구두 발표로 선정되었다고 발표했습니다. 이 치료제는 비만 및 대사 질환 환자를 위해 하루에 한 번 복용하는 정제와 주 1회 피하 주사 두 가지 형태로 개발되고 있습니다.
경구용 프로그램은 OPKO의 장시간 작용하는 옥신토모듈린 유사체와 Entera의 N-Tab™ 기술을 결합한 것입니다. 두 회사는 2025년 후반에 FDA에 IND 신청서를 제출하고 1상 임상시험을 진행할 계획입니다. 발표에서는 2025년 7월 13일 학회에서 새로운 약리학적 및 약동학적 생체 내 데이터를 선보일 예정입니다.
OPKO Health (NASDAQ : OPK) et Entera Bio ont annoncé que leur résumé concernant l'OPK-88006 oral, un nouveau traitement peptidique double GLP-1/glucagon, a été sélectionné pour une présentation orale lors de ENDO 2025 à San Francisco. Le traitement est développé à la fois sous forme de comprimé à prendre une fois par jour et d'injection sous-cutanée hebdomadaire pour les patients souffrant d'obésité et de troubles métaboliques.
Le programme oral combine l'analogue d'oxyntomoduline à longue durée d'action d'OPKO avec la technologie N-Tab™ d'Entera. Les entreprises prévoient de déposer une demande IND auprès de la FDA plus tard en 2025, suivie d'études cliniques de phase 1. La présentation mettra en avant de nouvelles données pharmacologiques et pharmacocinétiques in vivo lors de la conférence du 13 juillet 2025.
OPKO Health (NASDAQ: OPK) und Entera Bio gaben bekannt, dass ihr Abstract zum oralen OPK-88006, einer neuartigen dualen GLP-1/Glukagon-Peptid-Behandlung, für eine Präsentation auf dem ENDO 2025 in San Francisco ausgewählt wurde. Die Behandlung wird sowohl als einmal täglich einzunehmende Tablette als auch als wöchentliche subkutane Injektion für Patienten mit Adipositas und Stoffwechselstörungen entwickelt.
Das orale Programm kombiniert OPKOs langwirksames Oxyntomodulin-Analogon mit Enteras N-Tab™-Technologie. Die Unternehmen planen, später im Jahr 2025 einen IND-Antrag bei der FDA einzureichen, gefolgt von Phase-1-Studien. Die Präsentation wird auf der Konferenz am 13. Juli 2025 neue pharmakologische und pharmakokinetische In-vivo-Daten vorstellen.
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Insights
OPKO/Entera's novel oral GLP-1/glucagon dual agonist advances toward IND filing, entering the competitive obesity drug race.
This announcement marks significant progress for OPKO Health and Entera Bio's joint obesity treatment program, centered on OPK-88006, a dual GLP-1/glucagon agonist being developed in both oral tablet and injectable formats. The selection of their abstract for presentation at ENDO 2025 signals scientific validation of their preliminary data, while the planned IND filing later this year represents a crucial regulatory milestone.
The companies are targeting the rapidly expanding obesity therapeutics market currently dominated by injectable GLP-1 agonists. Their dual-mechanism approach differentiates their candidate, as glucagon activation can potentially enhance metabolic benefits beyond what GLP-1 alone provides. This dual-pathway approach could theoretically improve energy expenditure while maintaining GLP-1's appetite suppression effects.
The oral delivery format represents a significant potential advantage in this space. Current market-leading obesity treatments require injection, creating barriers to adoption for some patients. An effective oral alternative could capture substantial market share if it demonstrates comparable efficacy with improved convenience and tolerability.
The announcement suggests both companies are executing according to development timelines, with their IND filing progressing toward initiating human clinical trials. However, investors should recognize this program remains in preclinical stages with years of clinical development required before potential commercialization. The upcoming presentation will provide crucial insights into whether their pharmacokinetic data supports further development of this promising but early-stage candidate.
MIAMI and JERUSALEM, June 25, 2025 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ: OPK) and Entera Bio Ltd. (NASDAQ: ENTX) (“Entera”) today announced that new pharmacologic and pharmacokinetic in vivo data for investigational oral OPK-88006 tablet treatment has been selected for presentation at the ENDO 2025 annual meeting of the Endocrine Society, taking place July 12-15, 2025 in San Francisco, CA, USA.
Oral OPK-88006 is being developed pursuant to a collaboration and license agreement between OPKO and Entera whereby the companies are advancing a proprietary novel dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment and as a weekly subcutaneous injection for patients with obesity, metabolic and fibrotic disorders. The oral program combines OPKO’s proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab™ technology.
“Oral peptides remain rare in metabolic therapy, and having both tablet and injectable formats with our partner OPKO should allow us to tailor induction and maintenance regimens to each patient to optimize outcomes,” said Miranda Toledano, Chief Executive Officer of Entera. “Our once-daily tablet may be simpler to titrate and offer tolerability benefits. Our joint program prioritizes durable, sustainable weight loss to help prevent or mitigate comorbidities such as severe fatty liver, sleep apnea, and other metabolic disorders.”
OPKO and Entera expect to file an Investigational New Drug application with the U.S. Food and Drug Administration later this year for both oral OPK-88006 tablet and a weekly injectable variant of the same molecule, which OPKO intends to develop independently. Phase 1 clinical studies are being planned.
Abstract Title: First-in-Class Oral Dual GLP-1/Glucagon Agonist for Patients with Obesity and Metabolic Disorders: In Vivo Pharmacokinetic and Pharmacodynamic Results
Presentation Number: SUN-680
Session Date/Time: Sunday, July 13, 2025, 12:00 – 01:30 PM Pacific time
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)), 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; 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 anticipated benefits of both the daily tablet and an injectable form; Entera’s and OPKO’s expectations regarding licensing, business transactions, including OPKO’s development efforts should Entera opt-out, and strategic collaborations; 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
FAQ
What is OPK-88006 and what is it being developed for?
When will OPKO and Entera Bio present their OPK-88006 data at ENDO 2025?
What are the potential advantages of OPK-88006's oral formulation?
When do OPKO and Entera Bio plan to file their IND application for OPK-88006?
