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Entera Bio and OPKO Health Provide Update on PK/PD Results of Oral Oxyntomodulin (GLP-1/Glucagon) Peptide Tablet Candidate for Obesity and Metabolic Disorders
JERUSALEM and MIAMI, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and
About this update from Entera Bio Ltd.
[{"type":"text","content":"JERUSALEM and MIAMI, Sept. 25, 2024 (GLOBE NEWSWIRE) -- Entera Bio Ltd. (NASDAQ: ENTX) (Entera), a leader in the development of orally delivered peptides, and OPKO Health, Inc. (NASDAQ: OPK) (OPKO) announced today topline pharmacokinetic/pharmacodynamic (PK/PD) results from their ongoing collaborative research combining a proprietary long-acting oxyntomodulin (OXM) analog developed by OPKO and Entera’s proprietary N-Tab™ technology. The program is focused on developing the first oral dual agonist GLP-1/glucagon peptide as a potential once-daily treatment for patients with obesity, metabolic and fibrotic disorders. OXM is a naturally occurring peptide hormone found in the small intestine that acts to suppress appetite and induce weight loss. Entera and OPKO have completed in vivo proof-of-concept PK/PD studies in rodent and pig models. The studies’ objectives were met with oral OXM exhibiting significant systemic exposure following a single dose in both models. Furthermore, a favorable PK profile and bioavailability were shown with oral OXM. In the pig model, oral OXM achieved high plasma concentrations with prolonged systemic exposure, which is consistent with the reported half-life for semaglutide (Rybelsus®), the only approved oral GLP-1 analog. To assess the pharmacologic effect of oral OXM, a glucose tolerance test was performed in rats. Oral OXM showed a statistically significant reduction in plasma glucose levels post-glucose administration compared with placebo. Entera and OPKO plan to present these data at an upcoming clinical conference. “We are very pleased with the progress we are making in our collaboration with OPKO. These bioavailability and pharmacological data support continuing toward IND-enabling efforts for the program,” said Miranda Toledano, Entera Chief Executive Officer. OPKO previously reported that weekly injections of pegylated OXM demonstrated significant weight loss and reduction in HbA1, triglyceride and cholesterol levels in 113 obese and diabetic patients in a Phase 2B study. The OXM agonist peptide has since been modified to maintain its long-acting profile while increasing its potential potency. Currently, there are no approved OXM agonists available, and those in development by others are small molecules or require subcutaneous injections. About Entera Bio Entera is a clinical-stage company focu...