Opko and Entera Partner to Develop First Oral GLP-1/Glucagon Agonist for Obesity and Metabolic Disorders

Opko Health and Entera Bio have formalized a partnership to develop the first orally administered dual agonist glucagon-like peptide-1 (GLP-1)/glucagon peptide, setting the stage for a potential breakthrough in the treatment of obesity and related metabolic disorders. The collaboration aims to combine Opko's long-acting peptide technology with Entera's innovative oral delivery platform, potentially offering patients a more convenient alternative to existing injectable therapies.

Partnership Details and Development Plans

The agreement outlines a 60/40 ownership split between Opko and Entera, respectively, with development costs shared in the same proportion. Opko will invest in Entera by purchasing 3.6 million shares at $2.17 each, slightly above the market price, to help fund Entera's portion of the development costs through the phase 1 trial.

The companies plan to seek FDA approval to begin human trials later this year, marking a significant milestone as the first oral GLP-1/glucagon agonist to enter clinical testing. The once-daily pill, known as OPK-88006, combines Opko's dual agonist peptide with Entera's N-Tab oral delivery technology.

Market Landscape and Potential Impact

The partnership enters a competitive landscape dominated by injectable GLP-1 agonists, including Novo Nordisk's Wegovy and Eli Lilly's dual GLP-1/GIP agonist Zepbound. However, Opko and Entera's approach of targeting both GLP-1 and glucagon receptors in an oral formulation could potentially offer unique benefits.

Dr. Phillip Frost, CEO of Opko, emphasized the significance of this development, stating, "We are pleased to continue working with Entera on this promising program 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."

Broader Implications and Future Prospects

The development of an oral GLP-1/glucagon agonist could have far-reaching implications beyond obesity treatment. The companies are exploring its potential in addressing metabolic dysfunction-associated steatohepatitis (MASH) and other fibrotic disorders. This aligns with efforts by other pharmaceutical giants, such as AstraZeneca and Merck & Co., who are investigating similar dual agonist approaches for liver conditions.

As the program progresses, Entera will have the option to continue funding its share of development to maintain its 40% ownership or reduce its stake to 15%, with Opko assuming full development responsibilities. This flexibility allows for continued collaboration while providing a safety net for both companies as they navigate the challenging landscape of drug development.