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
Entera Bio (NASDAQ: ENTX) and OPKO Health (NASDAQ: OPK) announced their abstract for oral OPK-88006, a first-in-class dual GLP-1/glucagon agonist tablet, has been selected for presentation at ENDO 2025 in San Francisco. The drug candidate, developed through their collaboration, is being advanced as both a once-daily tablet and a weekly subcutaneous injection for treating obesity and metabolic disorders.
The oral formulation 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 for both formulations, followed by Phase 1 clinical studies.
Entera Bio (NASDAQ: ENTX) e OPKO Health (NASDAQ: OPK) hanno annunciato che il loro abstract relativo a OPK-88006 orale, una compressa innovativa con doppia azione agonista GLP-1/glucagone, è stato selezionato per una presentazione al ENDO 2025 a San Francisco. Il candidato farmaco, sviluppato in collaborazione, è in fase di avanzamento sia come compresse da assumere una volta al giorno sia come iniezione sottocutanea settimanale per il trattamento dell'obesità e dei disturbi metabolici.
La formulazione 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 per entrambe le formulazioni, seguita da studi clinici di Fase 1.
Entera Bio (NASDAQ: ENTX) y OPKO Health (NASDAQ: OPK) anunciaron que su resumen sobre OPK-88006 oral, una tableta innovadora de doble agonista GLP-1/glucagón, ha sido seleccionada para presentación en ENDO 2025 en San Francisco. El candidato a medicamento, desarrollado en colaboración, se está avanzando tanto como una tableta diaria como una inyección subcutánea semanal para tratar la obesidad y trastornos metabólicos.
La formulación 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 a la FDA a finales de 2025 para ambas formulaciones, seguida de estudios clínicos de Fase 1.
Entera Bio (NASDAQ: ENTX)와 OPKO Health (NASDAQ: OPK)는 경구용 OPK-88006에 대한 초록이 샌프란시스코에서 열리는 ENDO 2025에서 발표될 예정임을 발표했습니다. 이 약물 후보는 GLP-1/글루카곤 이중 작용제인 최초의 경구용 정제로, 두 회사의 협력을 통해 개발되었으며, 비만 및 대사 질환 치료를 위해 하루 한 번 복용하는 정제와 주 1회 피하 주사 형태로 개발되고 있습니다.
경구 제형은 OPKO의 장시간 작용하는 옥신토모듈린 유사체와 Entera의 N-Tab™ 기술을 결합한 것입니다. 양사는 2025년 말까지 두 제형 모두에 대해 FDA에 IND 신청서 제출를 계획하고 있으며, 이후 1상 임상 시험을 진행할 예정입니다.
Entera Bio (NASDAQ : ENTX) et OPKO Health (NASDAQ : OPK) ont annoncé que leur résumé concernant OPK-88006 oral, un comprimé innovant agoniste double GLP-1/glucagon, a été sélectionné pour une présentation lors du ENDO 2025 à San Francisco. Le candidat-médicament, développé en collaboration, est en développement à la fois sous forme de comprimé à prise quotidienne et d'injection sous-cutanée hebdomadaire pour le traitement de l'obésité et des troubles métaboliques.
La formulation orale combine l'analogue 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 d'ici la fin 2025 pour les deux formulations, suivie d'études cliniques de phase 1.
Entera Bio (NASDAQ: ENTX) und OPKO Health (NASDAQ: OPK) haben bekannt gegeben, dass ihr Abstract zu OPK-88006, einem neuartigen oralen Dual-GLP-1/Glucagon-Agonisten, für eine Präsentation auf der ENDO 2025 in San Francisco ausgewählt wurde. Der Wirkstoffkandidat, der in Zusammenarbeit entwickelt wurde, wird sowohl als einmal täglich einzunehmende Tablette als auch als wöchentliche subkutane Injektion zur Behandlung von Fettleibigkeit und Stoffwechselerkrankungen vorangetrieben.
Die orale Formulierung kombiniert OPKOs langwirksames Oxyntomodulin-Analogon mit Enteras N-Tab™-Technologie. Die Unternehmen planen, später im Jahr 2025 einen IND-Antrag bei der FDA für beide Formulierungen einzureichen, gefolgt von Phase-1-Studien.
- None.
- None.
Insights
OPKO/Entera's oral GLP-1/glucagon dual agonist advances toward IND filing, targeting the lucrative obesity market with differentiated tablet formulation.
This announcement represents a significant milestone in OPKO and Entera's co-development of a potential first-in-class oral dual GLP-1/glucagon agonist for obesity and metabolic disorders. The selection of their abstract for presentation at ENDO 2025 provides validation from the scientific community and suggests promising preclinical data exists for their novel approach.
The collaboration leverages complementary technologies: OPKO's oxyntomodulin analog (OPK-88006) with Entera's proprietary N-Tab™ oral delivery platform. What distinguishes this program is its dual-format strategy — developing both a once-daily tablet and weekly injectable formulation of the same molecule — potentially offering significant commercial advantages in the rapidly expanding GLP-1 market.
The oral tablet format addresses a critical gap in the current obesity treatment landscape. While injectable GLP-1s dominate the market, an oral option could significantly increase patient acceptance, simplify dose titration, and potentially offer improved tolerability profiles. The dual GLP-1/glucagon mechanism differs from pure GLP-1 agonists by potentially delivering more potent weight loss through complementary metabolic pathways.
The companies' timeline indicates progression to IND filing later this year, followed by Phase 1 trials. This positions ENTX, particularly as the smaller partner, at a pivotal inflection point. For Entera, this program represents validation of their oral peptide delivery technology in one of pharma's hottest therapeutic areas, potentially transforming the company's valuation if clinical development proceeds successfully.
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
When will Entera Bio (NASDAQ: ENTX) present their OPK-88006 data at ENDO 2025?
What is OPK-88006 being developed for by Entera Bio and OPKO Health?
What are the two delivery methods being developed for OPK-88006?
When will Entera Bio and OPKO Health file the IND application for OPK-88006?
