OPKO Health and Entera Bio, a developer of oral peptides and protein replacement therapies, entered into a license agreement to advance into the clinic the first oral dual agonist GLP-1/glucagon peptide as a once-daily tablet treatment for patients with obesity, metabolic, and fibrotic disorders. 

The program combines OPKO’s oxyntomodulin analog (OPK-88006) and Entera’s N-Tab technology. The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year.

Oxyntomodulin is a naturally occurring GLP-1/glucagon dual agonist peptide hormone found in the small intestine that acts to suppress appetite, induce weight loss, and has additional cardioprotective and anti-fibrotic attributes.

OPK-88006 is a GLP-1/glucagon dual agonist peptide that has been modified to maintain its long-acting profile while increasing its potential potency. Currently, there are no approved dual GLP-1/glucagon agonists available.

Under the terms of the agreement, OPKO and Entera will hold 60% and 40% pro-rata ownership interests, respectively, in the program and be responsible for 60% and 40% of the program’s development costs, respectively. 

In connection with the execution of the agreement, OPKO purchased 3,685,226 ordinary shares of Entera for a purchase price equal to $2.17 per share. Entera has agreed to utilize the proceeds from the sale of the shares to fund its 40% share of costs through Phase 1 of the development program. 

After the Phase 1 stage is complete, Entera can continue to fund its 40% share to maintain its pro-rata ownership interest in the program. Should Entera opt out, Entera will retain a 15% ownership interest in the Oral OXM program, while OPKO will retain 85% and be responsible for ongoing development activities and funding of the program.