Protara Therapeutics Highlights Choline Deficiency Study Results
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Protara Therapeutics Unveils THRIVE-1 Study Findings
In an effort to shed light on critical health concerns, Protara Therapeutics, Inc. (Nasdaq: TARA) has announced compelling results from their recent study, THRIVE-1. This prospective observational study focused on the prevalence of choline deficiency and liver injury in patients who rely on parenteral support (PS). The findings were highlighted at the European Society for Clinical Nutrition and Metabolism Congress.
Study Results Reveal Choline Deficiency Concerns
The study uncovered that a staggering 78% of participants dependent on parenteral support were found to be choline deficient. Alarmingly, 63% of these individuals exhibited liver dysfunction, which included conditions such as steatosis, cholestasis, and hepatobiliary injury. These results underscore an urgent need for intravenous (IV) choline supplementation among this vulnerable group.
Need for IV Choline Chloride
Protara Therapeutics is paving the way for IV Choline Chloride, an investigational therapy designed to address this significant unmet medical need. Choline plays an essential role in liver health, and its deficiency can lead to serious complications, including hepatic injury and various neuropsychological issues.
Professional Insights and Future Plans
Dr. Palle Bekker Jeppesen, a Clinical Professor specializing in intestinal failure and liver diseases, remarked on the findings, stating that many patients dependent on parenteral support could significantly benefit from IV Choline Chloride. The potential for an IV formulation is especially vital for those who cannot receive adequate choline through oral or enteral nutrition routes.
Company Commitment and Next Steps
Additionally, Jesse Shefferman, CEO of Protara Therapeutics, expressed their determination to introduce the first approved IV choline product to the market, particularly given the lack of such options currently available. The company aims to initiate a pivotal pharmacokinetic trial for IV Choline Chloride in early 2025.
THRIVE-1 Study Overview
The THRIVE-1 study was comprehensive, encompassing 78 patients dealing with intestinal failure who rely on parenteral support. With the results indicating a critical health gap, it is clear that attention must be focused on choline supplementation in these patients.
About IV Choline Chloride
IV Choline Chloride is positioned as an innovative therapeutic option. Given that around 80% of patients on parenteral support are choline deficient, introducing this therapy could prevent dire consequences related to liver damage and failure.
Potential Impact on Patient Care
This investigation is timely and addresses a substantial gap in the care and treatment of patients on parenteral support, who number around 40,000 in the U.S. alone. The implications of these findings may reshape how healthcare providers approach treatment strategies for these patients.
About Protara Therapeutics, Inc.
Protara is dedicated to enhancing treatment avenues for individuals grappling with cancer and rare diseases. With a diverse portfolio, their lead candidate, TARA-002, represents a significant advance in the treatment of specific cancer types. The company remains focused on ensuring that patients receive the vital therapies they need.
Frequently Asked Questions
What were the key findings of the THRIVE-1 study?
The study found that 78% of patients on parenteral support were choline deficient, with 63% of those experiencing liver dysfunction.
What is IV Choline Chloride?
IV Choline Chloride is an investigational therapy aimed at providing choline supplementation to patients unable to meet their needs through oral or enteral means.
How does choline deficiency affect patients?
Choline deficiency can lead to severe health issues, including liver injuries, neuropsychological impairments, and other complications.
Why is there a need for IV Choline products?
There are currently no approved IV choline products worldwide for parenteral support patients, despite medical recommendations advocating for choline treatment.
What are Protara's future plans?
Protara is planning to initiate a pivotal trial for IV Choline Chloride in early 2025, aiming to bring the first approved formulation to market.
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