Under the terms of the agreement, OPKO will accept 60% of the development costs, while Entera will shoulder 40%.
OPKO Health and Entera Bio on Monday teamed up to push an investigational oral obesity drug into clinical trials. The partners expect to file an Investigational New Drug application “later this year,” according to a statement.
If and when the partners do reach the clinic, they will forge a new path in the competitive weight-loss space. According to Monday’s news release, the candidate, OPK-88006, is set to be the first oral GLP-1/glucagon agonist to start human studies.
Under the terms of the agreement, OPKO and Entera will split development costs for and ownership over the oral peptide. OPKO, whose long-acting oxyntomodulin analog is the basis of the drug candidate, will shoulder 60% of the costs and hold the same percentage of pro-rata ownership interest. Entera, meanwhile, will provide its N-Tab platform that enables the drug to be taken orally and will take 40% of costs and ownership.
Aside from this split, OPKO purchased nearly 3.7 million ordinary shares of Entera at $2.17 apiece, a total of about $8 million amounting to about a 10% stake in the company. Entera meanwhile has agreed to use this money to fund its 40% share in OPK-88006’s Phase I program. After early-stage assessments, Entera will have the option to maintain its 40% contribution and ownership.
If Entera opts out, however, it will retain just 15% ownership interest in the OPK-88006 program, while the remaining 85% will go to OPKO, which in that case would be fully responsible for future development activities.
Formulated as a once-daily tablet, OPK-88006 is a dual agonist of the GLP-1 and glucagon receptors, a mechanism of action that helps control blood sugar and suppress appetite. The partners are proposing OPK-88006 as a treatment for obesity as well as other metabolic and fibrotic disorders.
This push to differentiate is in line with what other smaller players have been doing to compete in the GLP-1 space dominated by the much larger Novo Nordisk and Eli Lilly. Viking Therapeutics, for instance, is advancing a GLP-1/GIP dual receptor agonist that, unlike the currently approved weight-loss therapies, can be taken orally. Findings have been encouraging so far, with a Phase I readout in March 2024 pointing to a 3.3% reduction in body weight versus placebo.
Structure Therapeutics likewise seeks to target obesity orally, announcing in December 2024 that it will move forward with an amylin receptor agonist, for which a Phase I trial is planned by the end of 2025.
Altimmune, meanwhile, is trying to set itself apart from GLP-1 competitors by targeting different indications. The biotech is testing its GLP-1/glucagon agonist pemvidutide for metabolic-dysfunction associated steatohepatitis and alcohol-related disorders.
