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Entera Bio Unveils Promising PK Data for First Oral GLP-2 Therapy
ZACKS· 2025-09-18 13:45
Core Insights - Entera Bio Ltd. (ENTX) has reported promising pharmacokinetic data for its oral GLP-2 analog therapy, OPK-8801003, aimed at treating short bowel syndrome (SBS) [1][4] - The therapy is being developed in collaboration with OPKO Health and could provide a significant alternative to the current treatment, Gattex, which requires daily injections [2][11] Group 1: Therapy Development - OPK-8801003 combines OPKO Health's long-acting GLP-2 analog with Entera's N-Tab oral peptide platform, potentially transforming treatment for approximately 30,000 SBS patients in the U.S. and Europe [2][12] - The therapy demonstrated a plasma half-life of about 15 hours, which is 18 times longer than the 0.85-hour half-life of the current injection option [9][10] - Entera's oral therapy achieved peak plasma concentrations of nearly 200 ng/ml, significantly higher than the 36.8 ng/ml for subcutaneous teduglutide [10] Group 2: Market Potential - The SBS market is valued at nearly $800 million annually, and Entera's oral GLP-2 candidate could capture a share of this market by addressing the limitations of existing treatments [5][13] - The positive pharmacokinetic results not only advance the SBS program but also validate Entera's broader N-Tab oral peptide platform, indicating strong commercial potential [4][13] Group 3: Stock Performance and Investor Sentiment - Year-to-date, Entera Bio's stock has decreased by 15.5%, contrasting with a 3.1% gain in the industry and a 13.4% increase in the S&P 500 [3] - The encouraging pharmacokinetic data is expected to improve investor sentiment, as it serves as a de-risking milestone for the company's pipeline [4][5]
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
Globenewswire· 2025-09-15 13:00
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]