Protara Therapeutics, Inc. is a leading clinical-level biopharmaceutical company that has worked wonders in establishing life-changing, effective therapies for rare diseases and cancer. The company also conducted some major programs that brought awareness and development in certain crucial areas. Programs such as TARA-002 shed light on the immunotherapeutic area for lymphatic malformations and bladder cancer.
Protara uses scientific advancements to speed up its mechanism cycle for elevated development that travels to every corner of helplessness for health, and so to meet patients' needs across the globe.
Protara confirmed that the patient dosing has now begun in its Phase 3 registrational THRIVE-3 clinical trial. The trial is assessing intravenous (IV) Choline Chloride in patients engaged with long-standing parenteral support (PS). IV Choline Chloride is Protara’s investigational phospholipid substrate replacement therapy. This therapy was honored with a Fast Track designation by the US FDA agency.
The comprehensive THRIVE-3 Phase 2b/3 trial is engineered to examine the safety and efficacy of the IV Choline Chloride dosage volume in both adult and adolescent cohorts. The respective group holds a long-standing PS when there’s no place for any enteral or oral nutrition due to contraindication or shortage. The trial was followed by 8 weeks and 24 patients, while 105 patients are on the way to be registered in a 24-week Phase 3 placebo-balanced, shuffled trial.
The initial intention of the trial is to record the fluctuation in plasma choline concentration against the placebo’s comparison baseline. The patients will have the freedom to transition to an open-label extension timeframe on the completion of every stage of the study.
Chief Executive Officer of Protara Therapeutics, Jesse Shefferman, said, “We have noticed that extreme conditions like Choline have no such IV-approved choline products to diminish the severity of this deficiency. Choline can cause a deadly hepatic injury, muscle damage, thrombotic abnormalities, and neuropsychological impairment that has affected around 78% of the population relying on PS. Therefore, we think IV Choline Chloride is capable enough to bring a significant improvement in this population, lacking treatment for the same due to no access.”
“We believe this could be a first ever FDA-signed IV choline therapy for patients relying on PS. Furthermore, we’re planning to upgrade this fundamental study and deliver an interim analysis from the effective and promising trial by the second quarter of this year.”
Holding M.Pharm in Pharmaceutical Chemistry, Chandni crafts cutting-edge, research-driven healthcare news for Towards Healthcare, combining scientific depth with innovative storytelling to simplify complex topics for global readers.
