Opko Health and Entera Bio have formally announced their collaboration as the biopharmaceutical companies seek to advance the first orally given dual agonist glucagon-like peptide 1 (GLP-1)/glucagon peptide into clinical trials.
The once-daily tablet integrates Opko’s powerful GLP-1/glucagon dual agonist peptide, known as OPK-88006, via Entera’s N-Tab administration technology. The firms’ present schedule includes requesting FDA authorization later this year to commence human studies, as stated in a statement dated March 17.
The deal stipulates that Miami’s Opko and Israeli Entera will have 60% and 40% ownership, respectively, in the initiative, and will share the development expenditures in the same proportion.
Opko will acquire 3.6 million shares of Entera for $2.17 each, somewhat above the $1.88 closing price after Friday’s trading session. Entera will use the income to finance its portion of the development expenses leading up to the phase 1 study.
Subsequent to the first human trial, Entera will have the opportunity to further finance its portion of the research to maintain its stake in the program’s ownership. If the biotech chooses to withdraw at this juncture, it will retain a 15% ownership stake, while Opko would have the remaining 85% and assume the whole responsibility for research and finance.
The two prominent obesity medications already available are Novo Nordisk’s GLP-1 agonist Wegovy and Eli Lilly’s combination GLP-1/GIP agonist Zepbound. Currently, there are no licensed medicines that use Opko’s approach of concurrently stimulating the GLP-1 and glucagon receptors.
The big pharmaceutical companies have focused on assessing dual GLP-1/glucagon co-agonists as prospective therapies for metabolic dysfunction-associated steatohepatitis (MASH). AstraZeneca is developing its candidate, AZD9550, now in its first phase for liver disease, whereas Merck & Co.’s efinopegdutide outperformed Wegovy in a phase 2 study for nonalcoholic fatty liver disease.
Opko said that introducing their medicine in the clinic this year would be the first instance of an orally given GLP-1/glucagon agonist undergoing human testing. The expectation is that the medication may serve as a once-daily tablet therapy for those with obesity, metabolic problems, and fibrotic conditions.
Opko and Entera have already been working together on an obesity medication and an oral GLP-2 peptide tablet, which they anticipate will provide an injection-free option for individuals with unusual malabsorption disorders, including short bowel syndrome.
“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,” Phillip Frost, M.D., Onko’s CEO, stated in the release. “Our goal with this franchise is to provide additional options for patients with obesity, metabolic and fibrotic diseases.”
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