On March 17, 2025,
OPKO Health, Inc. and
Entera Bio Ltd. announced a collaboration to develop an innovative oral treatment targeting
obesity,
metabolic, and fibrotic disorders. This partnership aims to introduce the first oral dual agonist
GLP-1/
glucagon peptide in a once-daily tablet format. The collaboration leverages OPKO’s
oxyntomodulin analog, OPK-88006, and Entera’s N-Tab™ technology. Promising results regarding the drug’s pharmacodynamics, pharmacokinetics, and bioavailability were observed in studies conducted in September 2024. Both companies are preparing to submit an Investigational New Drug application to the FDA within the year.
The partnership agreement stipulates that OPKO will hold a 60% stake in the project, while Entera will maintain a 40% stake. OPKO is responsible for 60% of the development costs, with Entera covering the remaining 40%. To support its share of development expenses through Phase 1, OPKO acquired 3,685,226 ordinary shares of Entera at $2.17 per share. Post-Phase 1, Entera holds the option to continue funding its share to retain its proportional ownership. If Entera opts out, it will retain a 15% ownership interest, with OPKO assuming 85% ownership and continuing the development independently.
Phillip Frost, M.D., Chairman and CEO of OPKO, expressed optimism about the collaboration, stating that it reinforces efforts to offer more treatment options for patients dealing with obesity and related disorders. Miranda Toledano, Entera’s CEO, echoed this sentiment, highlighting the potential of their joint efforts to create pioneering oral peptide treatments.
Oxyntomodulin, the basis for OPK-88006, is a hormone found in the small intestine that naturally acts as a GLP-1/glucagon dual agonist. It is known to suppress appetite, promote weight loss, and provide cardiovascular and anti-fibrotic benefits. OPK-88006 is a modified peptide designed to enhance its long-acting properties and effectiveness. Currently, there are no approved dual GLP-1/glucagon agonists on the market, making this endeavor particularly groundbreaking.
Entera Bio Ltd., a clinical-stage company, is focused on developing oral therapies for unmet medical needs where oral delivery could revolutionize treatment practices. The company’s proprietary N-Tab™ technology underpins several programs, including five first-in-class oral peptide treatments targeting various health conditions. Their leading candidate, EB613, is being developed as the first oral osteoanabolic treatment for osteoporosis in post-menopausal women. A Phase 2 study demonstrated success in meeting primary and secondary endpoints, prompting plans for a Phase 3 trial. Entera is also pursuing EB612, a treatment for hypoparathyroidism, and developing oral oxyntomodulin for obesity in collaboration with OPKO. Additionally, they are working on an oral GLP-2 peptide for rare malabsorption conditions, aiming to offer an injection-free alternative.
OPKO Health is a multinational firm in the biopharmaceutical and diagnostics sectors, striving to secure top positions in growing markets through its expertise in discovery, development, and commercialization, along with its innovative technologies.
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