Protara Therapeutics Announces Dosing of First Patient in Phase 3 Registrational THRIVE-3 Trial of IV Choline Chloride in Patients on Long-Term Parenteral Support

Core Insights - Protara Therapeutics, Inc. has initiated patient dosing in its Phase 3 THRIVE-3 clinical trial for intravenous Choline Chloride, aimed at patients on long-term parenteral support [1][2] - The company believes that IV Choline Chloride could be the first FDA-approved IV choline therapy for patients dependent on parenteral support, addressing a significant unmet medical need [2][4] Company Overview - Protara Therapeutics is a clinical-stage biotechnology company focused on developing transformative therapies for cancer and rare diseases, with its lead candidate being TARA-002 for non-muscle invasive bladder cancer and lymphatic malformations [5][6] - The company is also developing IV Choline Chloride as a phospholipid substrate replacement therapy for patients unable to meet their choline needs through oral or enteral nutrition [4][5] Clinical Trial Details - The THRIVE-3 trial is a seamless Phase 2b/3 study designed to evaluate the efficacy and safety of low and high doses of IV Choline Chloride in patients receiving long-term parenteral support [2][3] - Approximately 105 additional patients will be enrolled in a 24-week Phase 3 double-blinded, randomized, placebo-controlled trial, following an 8-week Phase 2b trial involving 24 patients [2][3] Medical Context - Choline deficiency affects 78% of patients on parenteral support, leading to serious health issues, yet there are currently no approved IV choline products available [2][4] - IV Choline Chloride has been granted Fast Track and Orphan Drug Designation by the FDA, highlighting its potential significance in treating choline deficiency in this patient population [4][5]