OPK-8801003 / Entera Bio, OPKO Health - LARVOL DELTA

Key Data Presented at ESPEN (GlobeNewswire) - "Extended Half-Life: OPK-8801003 GLP-2 tablet demonstrated a plasma half-life of approximately 15 hours in minipigs, representing an approximate 18-fold improvement over teduglutide, which has a half-life of only 0.85 hours in the same species; Robust Oral Bioavailability: Following oral administration of OPK-8801003 tablets in minipigs, peak plasma concentrations reached ~200 ng/ml (Cmax), substantially exceeding the reported Cmax of 36.8 ng/ml for daily 0.05 mg/kg teduglutide subcutaneous injection in humans; Sustained Exposure: Systemic exposure (AUC ~2 h*μg/ml) was maintained for more than 24 hours with relatively low variability, supporting once-daily oral dosing."

Preclinical • Short Bowel Syndrome

Entera Bio Announces First Quarter 2025 Financial Results and Business Updates (GlobeNewswire) - "First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablet Candidate for Obesity...We expect to file an Investigational New Drug application with the FDA later this year or early in 2026...First GLP-2 Peptide Tablets for Short Bowel Syndrome....We plan to submit abstracts to a major clinical conference with PK/PD of the single daily tablet of GLP-2 in late 2025."

Clinical data • IND • Obesity • Short Bowel Syndrome

Entera Bio Reports Q3 2023 Financial Results, Highlights Transformational Steps and Unveils Vision as Premier Oral Peptide Company with Five Potential Programs in Development (BioSpace) - "Treatment with Glucagon-Like Peptide-2 (GLP-2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome (SBS) and reduce parenteral support requirements...Entera published pre-clinical data in May 2023 demonstrating that its oral peptide delivery platform enables gastric absorption of teduglutide, as a convenient potential tablet alternative to daily injections. OPKO and Entera expect to update on the program in the first half of 2024....First GLP-1/Glucagon Agonist (Oxyntomodulin) Peptide Tablets for Obesity...Under the collaboration agreement, OPKO will supply certain OXM analogs to combine with Entera’s oral peptide platform. OPKO and Entera expect to update on the program in the first half of 2024."

Clinical • Preclinical • Gastrointestinal Disorder • Metabolic Disorders • Obesity • Short Bowel Syndrome

Entera Bio Announces Collaboration with OPKO Biologics to Develop Oral Peptide Tablet Formulations for Obesity and Intestinal Malabsorption Syndromes (GlobeNewswire) - "Entera Bio Ltd...and OPKO Biologics, Inc...have entered into a Research Collaboration Agreement. Under the terms of the Agreement, OPKO will supply its proprietary long-acting GLP-2 peptide and certain Oxyntomodulin (OXM) analogs for the development of oral tablet formulations using Entera’s proprietary oral delivery technology....It is challenging to administer peptides orally due to their rapid degradation in the gastrointestinal tract and negligible permeability. Treatment with Glucagon-Like Peptide-2 (GLP-2) analogs has been shown to improve the absorption of nutrients in patients with short bowel syndrome (SBS) and reduce parenteral support requirements."

Licensing / partnership • Gastroenterology • Short Bowel Syndrome

Entera Bio Initiates New Research Program For Oral GLP-2 (GlobeNewswire) - "Entera Bio...today announced a new research program for an oral glucagon-like peptide-2 (GLP-2) analog based on the Company’s platform technology....Program Leverages Entera’s Platform for Potential Development of Oral GLP-2 Analogs for Gastrointestinal and Other Indications...GLP-2 Analogs Currently Administered Via Daily Injection to Treat Short Bowel Syndrome..."

New trial • Short Bowel Syndrome