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Entera Bio Reports Positive PK Data for First-in-Class Oral GLP-2 Tablet Treatment for Patients with Short Bowel Syndrome at the 2025 ESPEN Congress - Entera Bio (NASDAQ:ENTX)
Benzinga· 2025-09-15 13:00
Core Viewpoint - Entera Bio Ltd. has presented promising preclinical data for its oral GLP-2 analog, OPK-8801003, which could significantly improve treatment for Short Bowel Syndrome (SBS) patients who currently rely on daily injections of the peptide [1][3]. Company Overview - Entera Bio is a clinical-stage company focused on developing oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ technology platform [6]. - The company is collaborating with OPKO Health, Inc. to develop oral peptide candidates for intestinal malabsorption syndromes, specifically targeting SBS [2][8]. Product Development - OPK-8801003 demonstrated a plasma half-life of approximately 15 hours in preclinical studies, an 18-fold improvement over the current treatment, teduglutide, which has a half-life of only 0.85 hours [7]. - The peak plasma concentration of OPK-8801003 reached ~200 ng/ml, significantly higher than the reported Cmax of 36.8 ng/ml for teduglutide [7]. - The systemic exposure (AUC) was maintained for over 24 hours, supporting the potential for once-daily oral dosing [7]. Market Context - Approximately 30,000 patients in the U.S. and EU suffer from SBS, with the only approved therapy, Gattex® (teduglutide), generating around $800 million in annual sales [5][2]. - SBS is a leading cause of chronic intestinal failure, accounting for about 75% of cases in adults and 50% in children [5]. Future Implications - The robust oral bioavailability and favorable safety profile of OPK-8801003 could fundamentally change the treatment landscape for SBS, offering a less invasive administration method and personalized dosing options [3][7].