OPKO Health Announces New Data on Oral OPK-88006 at ENDO 2025

OPKO Health and Entera Bio announced new pharmacologic and pharmacokinetic data for oral OPK-88006, a dual agonist GLP-1/glucagon peptide for obesity and metabolic disorders, at ENDO 2025. The companies plan to file an Investigational New Drug application with the FDA later this year and are preparing for Phase 1 clinical studies. The development of both oral and injectable formats offers flexibility in treatment options, but regulatory approval processes can be lengthy and uncertain.

OPKO Health (NASDAQ: OPK) and Entera Bio (NASDAQ: ENTX) have made significant strides in their joint obesity treatment program by presenting new pharmacologic and pharmacokinetic data for oral OPK-88006 at ENDO 2025. The companies announced that the abstract for OPK-88006, a dual agonist GLP-1/glucagon peptide, has been selected for presentation at the annual meeting of the Endocrine Society in San Francisco on July 13, 2025 [1].

OPK-88006 is being developed as both a once-daily tablet and a weekly subcutaneous injection for patients with obesity and metabolic disorders. The oral program combines OPKO's long-acting oxyntomodulin analog with Entera's proprietary N-Tab™ technology. The companies plan to file an Investigational New Drug (IND) application with the FDA later this year, followed by Phase 1 clinical studies [2].

The presentation at ENDO 2025 will showcase new in vivo data, providing crucial insights into the efficacy and safety of OPK-88006. The dual-mechanism approach of OPK-88006, which combines GLP-1's appetite suppression effects with glucagon's potential to enhance metabolic benefits, differentiates it from existing obesity treatments. The oral delivery format represents a significant advantage over current market-leading injectable GLP-1 agonists, offering improved convenience and potential tolerability for patients [1].

While the announcement marks significant progress, it is important to note that OPK-88006 remains in preclinical stages. The upcoming presentation will provide valuable data to support further development, but investors should recognize that years of clinical development are required before potential commercialization [2].

In contrast, Novo Nordisk (NYSE: NVO) has recently announced that its investigational obesity treatment, amycretin, will advance directly to Phase 3 clinical development based on promising results from early-phase trials [3]. This rapid advancement highlights the competitive landscape in the obesity therapeutics market.

OPKO Health and Entera Bio's collaboration is focused on delivering a transformative oral treatment for obesity and metabolic disorders, potentially capturing a substantial market share with its oral delivery format. However, the regulatory approval process can be lengthy and uncertain, and investors should closely monitor the development timelines and clinical trial results.

References:
[1] https://www.stocktitan.net/news/OPK/opko-health-and-entera-bio-abstract-for-first-in-class-dual-glp-1-buci39mc8xnv.html
[2] https://www.biospace.com/press-releases/opko-health-and-entera-bio-abstract-for-first-in-class-dual-glp-1-glucagon-tablet-candidate-for-patients-with-obesity-and-metabolic-disorders-selected-for-presentation-at-the-endo-2025-annual-meeting
[3] https://ca.finance.yahoo.com/news/novo-nordisk-fast-tracks-amycretin-080938295.html