Core Insights - Entera Bio Ltd. is developing an oral GLP-2 therapy, OPK-8801003, which shows a significantly longer biological half-life and comparable peak plasma levels to the only approved GLP-2 therapy, Gattex [1][2][3] Company Overview - Entera Bio is focused on oral peptide and protein replacement therapies, leveraging its proprietary N-Tab™ platform to address significant unmet medical needs [6] - The company is collaborating with OPKO Health, Inc. to develop oral peptide candidates for intestinal malabsorption syndromes [2][6] Product Development - OPK-8801003 demonstrated a plasma half-life of approximately 15 hours in preclinical studies, an 18-fold improvement over teduglutide, which has a half-life of only 0.85 hours [7] - Peak plasma concentrations of OPK-8801003 reached ~200 ng/ml, significantly exceeding the reported Cmax of 36.8 ng/ml for teduglutide [7] - The systemic exposure of OPK-8801003 was maintained for over 24 hours, supporting once-daily oral dosing [7] Market Context - Short Bowel Syndrome (SBS) affects approximately 30,000 patients in the U.S. and EU, with current annual sales of Gattex totaling around $800 million [5] - SBS is the most common cause of chronic intestinal failure, accounting for about 75% of cases in adults and 50% in children [5]

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].