OPKO Health and Entera Bio have entered into a collaboration and licensing agreement to advance an oral GLP-1/glucagon tablet candidate aimed at treating obesity and metabolic disorders.
As part of the collaboration, OPKO’s long-acting oxyntomodulin analogue, OPK-88006, will be combined with Entera’s N-Tab technology. In vivo studies conducted in September 2024 showed positive pharmacodynamic, pharmacokinetic, and bioavailability results.
Both companies plan to submit an Investigational New Drug application to the US Food and Drug Administration later this year.
Under the agreement, OPKO and Entera will hold respective ownership interests of 60% and 40% in the programme, sharing development costs in the same proportion. Concurrently, OPKO has acquired 3,685,226 ordinary shares of Entera at $2.17 per share. Entera will use the proceeds to cover its 40% share of the costs through Phase 1 of the development.
After Phase 1, Entera can choose to continue funding its share to maintain its ownership interest. If Entera opts out, it will retain a 15% stake in the Oral OXM programme, with OPKO assuming 85% ownership and full responsibility for future development and funding.
OPKO chairman and CEO Phillip Frost said: “We are pleased to continue working with Entera on this promising programme to develop the first oral GLP-1/glucagon dual agonist in addition to our subcutaneous injectable dual agonist GLP-1/glucagon program.
“Our goal with this franchise is to provide additional options for patients with obesity, metabolic and fibrotic diseases.”
Entera CEO Miranda Toledano said: “We have enjoyed our synergistic partnership with OPKO. This expanded collaboration on the GLP-1/glucagon program reinforces our shared vision to develop first-in-class differentiated oral peptide treatments for patients to better manage their health.”
Oxyntomodulin, a naturally occurring GLP-1/glucagon dual agonist peptide hormone, is found in the small intestine and plays a role in appetite suppression, and weight loss, and offers cardioprotective and anti-fibrotic benefits.
OPK-88006, a modified GLP-1/glucagon dual agonist peptide, is designed to retain its long-acting properties while enhancing potency. Currently, no dual GLP-1/glucagon agonists have received approval.
