(RTTNews) - Protara Therapeutics, Inc. (TARA) has dosed the first patient in its pivotal Phase 3 registrational THRIVE-3 trial evaluating intravenous (IV) Choline Chloride in patients dependent on long-term parenteral support (PS).
The study aims to establish IV choline as the first FDA-approved therapy to address choline deficiency in this underserved population.
Choline deficiency affects nearly 78% of patients on long-term PS, leading to risks of hepatic injury, neuropsychological impairment, muscle damage, and thrombotic abnormalities. Despite this burden, there are currently no approved IV choline products globally.
The THRIVE-3 is a seamless Phase 2b/3 study designed to assess the efficacy and safety of low- and high-dose IV Choline Chloride in adolescent and adult patients. Following an 8-week Phase 2b open-label dose-confirmation study in 24 patients, approximately 105 additional patients will be enrolled in a 24-week, double-blind, randomized, placebo-controlled Phase 3 trial.
The primary endpoint will measure the change in plasma choline concentration from baseline compared to placebo. Patients completing each phase will be eligible to enter an open-label extension to evaluate long-term outcomes.
IV Choline Chloride has received Fast Track and Orphan Drug Designation from the FDA, underscoring its potential to become the first approved IV choline therapy for PS patients. Interim analysis from THRIVE-3 is expected in the second half of 2026.
TARA has traded between $2.77 and $7.82 over the past year. The stock is currently trading at $5.46, up 6.42%.
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
