Clinical-stage company Protara Therapeutics Inc. (TARA) announced on Monday the results of THRIVE-1, a prospective observational study investigating the prevalence of choline deficiency and liver injury among patients reliant on parenteral support (PS).
The study revealed that 78% of PS-dependent patients were choline deficient and 63% of these choline-deficient individuals experienced liver dysfunction, including conditions such as steatosis, cholestasis, and hepatobiliary injury. These findings highlight the necessity for intravenous (IV) choline supplementation in this patient group.
Protara is currently developing IV Choline Chloride, an investigational therapy aimed at replacing phospholipid substrates, serving as a choline source when oral or enteral nutrition is impractical, insufficient, or contraindicated.
"These findings emphasize the significant number of PS-dependent patients who could potentially benefit from IV Choline Chloride therapy," said Palle Bekker Jeppesen, M.D., Ph.D., Clinical Professor in the Department of Intestinal Failure and Liver Diseases at Rigshospitalet, Copenhagen University Hospital, Denmark. "Choline is crucial for PS-dependent patients, as deficiency can result in hepatic injury, neuropsychological impairment, muscle damage, and thrombotic abnormalities. Access to an IV formulation of choline could profoundly impact patients for whom oral or enteral supplementation is not an option."
