OPKO Health and Entera Bio Partner to Advance Oral GLP-1 Tablet for Obesity and Metabolic Disorders

OPKO Health, Inc. and Entera Bio Ltd., a leader in the development of oral peptides and proteins replacement therapies, entered into a collaboration and 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 proprietary long-acting oxyntomodulin analog (OPK-88006) and Entera’s proprietary N-Tab™ technology. Favorable pharmacodynamic, pharmacokinetic and bioavailability data in vivo were reported in September 2024. The companies expect to file an Investigational New Drug application with the U.S. Food and Drug Administration (FDA) later this year.

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. Following the completion of the Phase 1 stage, Entera has the option to continue to fund its 40% share to maintain its pro-rata ownership interest of 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.

“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,” said Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.

“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,” said Miranda Toledano, Entera Chief Executive Officer.

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.