Clinical-stage company Protara Therapeutics Inc. (TARA) Monday announced the results of THRIVE-1, a prospective, observational study evaluating the prevalence of choline deficiency and liver injury in patients dependent on parenteral support (PS).
The study found that 78% of patients who are dependent on PS were choline deficient, and that 63% of choline deficient participants had liver dysfunction, including steatosis, cholestasis, and hepatobiliary injury, underscoring the need for intravenous (IV) choline supplementation in this patient population.
Protara is developing IV Choline Chloride, an investigational phospholipid substrate replacement therapy, as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated.
"Findings from this study reinforce that there are a significant number of people dependent on PS who may potentially benefit from treatment with IV Choline Chloride," said Palle Bekker Jeppesen M.D., Ph.D., Clinical Professor, Department of Intestinal Failure and Liver Diseases, Rigshospitalet, Copenhagen University Hospital, Copenhagen, Denmark. "Choline is essential for PS dependent patients, as deficiency can lead to hepatic injury, neuropsychological impairment, muscle damage, and thrombotic abnormalities. Access to an IV formulation of choline has the potential to meaningfully impact patients for whom oral or enteral choline supplementation is not an option."
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