Protara Therapeutics announced results from THRIVE-1, a study on choline deficiency and liver injury in patients dependent on parenteral support (PS). The study found that 78% of PS patients were choline deficient and 63% of those deficient also experienced liver dysfunction. Protara plans to start the THRIVE-3 registrational trial for their intravenous (IV) Choline Chloride product in the first half of 2025.
These findings are crucial for patients reliant on PS who currently lack an effective way to receive choline, a vital nutrient. The high prevalence of choline deficiency and associated liver damage highlights a serious unmet medical need within this population. Developing an IV Choline Chloride formulation offers a potential solution to prevent and treat this deficiency, thereby improving liver health and overall well-being for these individuals.
THRIVE-1 was a prospective, observational study. The upcoming THRIVE-3 trial is a seamless Phase 2b/3 clinical trial designed with a dose confirmation phase (n=24) followed by a larger, double-blind, placebo-controlled phase (n=100) in adolescents and adults on long-term PS. The trial will assess both efficacy and safety of IV Choline Chloride. The product has already received Fast Track designation from the FDA, and both ASPEN and ESPEN recommend IV choline for PS patients.
The positive results from THRIVE-1 and the initiation of THRIVE-3 suggest a promising future for IV Choline Chloride. If successful, this therapy could become the first FDA-approved IV choline formulation, addressing a substantial clinical need and significantly improving the quality of life for patients dependent on parenteral support. This innovation holds potential to become a standard of care for this population, altering current clinical practice guidelines and creating new market opportunities.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
