OPKO Health and Entera Bio announced that new pharmacologic and pharmacokinetic in vivo data for their 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.
The oral OPK-88006 is being developed through a collaboration and license agreement between OPKO and Entera, advancing a proprietary novel dual agonist GLP-1/glucagon peptide as both a once-daily tablet treatment and a weekly subcutaneous injection for patients with obesity, metabolic and fibrotic disorders.
Novel Oral Peptide Technology
The oral program combines OPKO's proprietary long-acting oxyntomodulin analog (OPK-88006) with Entera's proprietary N-Tab™ technology. This represents a significant advancement in metabolic therapy, as oral peptides remain rare in this therapeutic area.
"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."
Clinical Development Timeline
OPKO and Entera expect to file an Investigational New Drug application with the U.S. Food and Drug Administration later this year for both the 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 following the regulatory submissions.
Conference Presentation Details
The research will be presented at ENDO 2025 under the 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) on Sunday, July 13, 2025, from 12:00 – 01:30 PM Pacific time.
Company Portfolios
Entera Bio is a clinical-stage company focused on developing oral peptide and protein replacement therapies using its disruptive N-Tab™ technology platform. The company's pipeline includes first-in-class oral peptide programs targeting PTH(1-34), GLP-1 and GLP-2. Their most advanced product candidate, EB613 (oral PTH(1-34)), completed a placebo-controlled, dose-ranging Phase 2 study (n=161) that met primary and secondary endpoints for post-menopausal women with low BMD and high-risk osteoporosis.
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 novel proprietary technologies.
