Protara Therapeutics Announces Results from THRIVE-1, a Prospective Observational Study Evaluating the Prevalence of Choline Deficiency and Liver Injury in Patients Dependent on Parenteral Support

Core Insights - Protara Therapeutics announced the results of the THRIVE-1 study, highlighting a significant prevalence of choline deficiency and liver dysfunction in patients dependent on parenteral support [1][2][4] - The company is developing IV Choline Chloride as a potential treatment to address this unmet medical need, with plans to initiate a pivotal trial in Q1 2025 [1][3][6] Study Findings - The THRIVE-1 study involved 78 patients, revealing that 78% were choline deficient, and 63% of those with deficiency exhibited liver dysfunction, including steatosis and cholestasis [2][4] - The study underscores the critical need for intravenous choline supplementation in this patient population [2][3] Product Development - IV Choline Chloride is an investigational therapy aimed at providing choline when oral or enteral nutrition is insufficient or contraindicated [2][7] - The product has received Orphan Drug Designation from the FDA for preventing choline deficiency in patients on parenteral support [8] Market Opportunity - Approximately 40,000 patients in the U.S. on long-term parenteral support could benefit from an IV formulation of choline [8] - Currently, there are no approved IV choline products for patients dependent on parenteral support, despite recommendations from professional medical societies [5][3] Company Commitment - Protara is dedicated to bringing the first approved IV formulation of choline to the parenteral support community and is preparing for a registrational trial [3][6]