Opko Health and Entera Bio have formalized their partnership as the biotechs prepare to take the first orally administered dual agonist glucagonlike-peptide 1 (GLP-1)/glucagon peptide into the clinic.
The once-daily pill combines Opko’s long-acting GLP-1/glucagon dual agonist peptide, dubbed OPK-88006, with Entera’s N-Tab oral delivery tech. The companies’ current timetable would involve seeking permission from the FDA “later this year” to enter human trials, according to a March 17 release.
The agreement will see Miami-based Opko and Israel-based Entera holding 60% and 40% ownership, respectively, in the program, and sharing the development costs by the same ratio.
Opko will also buy 3.6 million shares of Entera at $2.17 a pop, slightly above the $1.88 price at which the shares closed after Friday’s trading. Entera will use the proceeds to help fund its side of the development costs through to the phase 1 trial.
Beyond that first human study, Entera will then have the option to continue to fund its side of the development in order to retain its part of the program’s ownership. If the biotech decides at this point to opt out, it will still keep a 15% ownership interest, with Opko accounting for the remaining 85% while taking on the full development and funding burden.
The two blockbuster obesity drugs already on the market are Novo Nordisk’s GLP-1 agonist Wegovy and Eli Lilly’s dual GLP-1/GIP agonist Zepbound. However, there are not yet any approved therapies that follow Opko’s modality of simultaneously activating the GLP-1 and glucagon receptors.
Big Pharmas have tended to evaluate dual GLP-1/glucagon co-agonists as potential treatments for metabolic dysfunction-associated steatohepatitis (MASH). AstraZeneca has its own candidate, dubbed AZD9550, in phase 1 development for the liver condition, while Merck & Co.’s efinopegdutide beat Wegovy in the related condition of nonalcoholic fatty liver disease in a phase 2 trial.
Opko said taking their drug into the clinic this year would mark the first time an orally administered GLP-1/glucagon agonist would enter human trials. The hope is that the med can be used as a once-daily table treatment for patients with obesity as well as metabolic and fibrotic disorders.
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Opko and Entera have already been collaborating on the obesity drug as well as on an oral GLP-2 peptide tablet they hope will offer an injection-free alternative for patients suffering from rare malabsorption conditions such as 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,” Onko’s CEO Phillip Frost, M.D., said in the release. “Our goal with this franchise is to provide additional options for patients with obesity, metabolic and fibrotic diseases.”