Entera Bio and OPKO Health Unveil Breakthrough Oxyntomodulin Results
Introduction to Entera Bio and OPKO Health's Collaboration
Entera Bio Ltd. (NASDAQ: ENTX) and OPKO Health, Inc. (NASDAQ: OPK) have achieved a significant milestone in their partnership focused on developing innovative therapies for obesity and metabolic disorders. The companies have released topline results from their pharmacokinetic and pharmacodynamic (PK/PD) studies, showcasing promising outcomes for their oral oxyntomodulin treatment.
Details of the PK/PD Study
The collaboration is centered around a proprietary long-acting oxyntomodulin analog crafted by OPKO, combined with Entera’s unique N-Tab™ technology. This study aims to create the first oral dual agonist for GLP-1 and glucagon, potentially allowing patients to benefit from a once-daily tablet. Oxyntomodulin, a hormone produced in the small intestine, is pivotal in regulating appetite and aiding in weight loss.
Breakthroughs in Rodent and Pig Models
In their rigorous research, Entera and OPKO successfully conducted in vivo PK/PD studies in both rodent and pig models. The found results were remarkable, indicating substantial systemic exposure from a single oral dose of oxyntomodulin in both species. The pig model, in particular, demonstrated a significant increase in plasma concentrations over a prolonged period, comparable to semaglutide, the single oral GLP-1 analog approved for clinical use.
Pharmacologic Effects and Future Steps
A glucose tolerance test in rats highlighted oxyntomodulin's effectiveness, showing a statistically significant reduction in plasma glucose levels after glucose administration versus a placebo. These encouraging results affirm the program's direction, leading to upcoming presentations at clinical conferences.
Leadership Insights
Miranda Toledano, the CEO of Entera, expressed her enthusiasm about the team's progress with OPKO: “The bioavailability and pharmacological data we are gathering are crucial for advancing toward our IND-enabling efforts.”
Historical Context and Market Position
Previously, OPKO shared findings on their pegylated oxyntomodulin, which facilitated weight loss in a Phase 2B clinical study involving 113 patients with obesity and diabetes. Ongoing enhancements of the oxyntomodulin agonist have been made to augment its potency while sustaining its long-acting characteristics. Currently, there are no approved oxyntomodulin agents, with most derivatives in competition being either small molecules or requiring injection methods.
About Entera Bio
Entera is making strides as a clinical-stage company devoted to developing oral peptide therapies that address significant medical needs. Their N-Tab™ platform is at the forefront of this innovative approach. With an exciting pipeline, Entera anticipates entering clinical phases for five distinct oral peptide programs by 2025. Their leading candidate, EB613 (oral PTH (1-34)), is particularly noteworthy as it is set to revolutionize the treatment for post-menopausal women facing osteoporosis. They have recorded promising data from a Phase 2 study and are gearing up for a Phase 3 registrational study aimed at further validating this groundbreaking therapy.
About OPKO Health
OPKO Health stands as a multifaceted biopharmaceutical firm that aims to capture leading positions within fast-growing markets through its extensive expertise in discovery, development, and commercialization. Their commitment to innovation is evident as they progress in both diagnostics and integrated medicine solutions.
Frequently Asked Questions
What is the focus of Entera Bio and OPKO Health's collaboration?
The collaboration aims to develop an oral dual agonist for GLP-1 and glucagon to treat obesity and metabolic disorders.
What were the results of the PK/PD studies?
The studies demonstrated significant systemic exposure from a single oral dose and promising pharmacologic effects in animal models.
How does oxyntomodulin function?
Oxyntomodulin is a peptide hormone that helps suppress appetite and promote weight loss, playing a crucial role in metabolic regulation.
What is Entera Bio’s leading product candidate?
Entera’s leading candidate is EB613, an oral PTH (1-34) being developed as a therapy for osteoporosis.
What future plans do Entera and OPKO have?
The companies plan to present their PK/PD findings at upcoming clinical conferences and continue advancing their therapy toward regulatory approval.
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