お知らせ • Jan 08
Protara Therapeutics, Inc. Announces Dosing of First Patient in Phase 3 Registrational Thrive-3 Trial of Iv Choline Chloride in Patients on Long-Term Parenteral Support
Protara Therapeutics, Inc. announced that patient dosing is now underway in its Phase 3 registrational THRIVE-3 clinical trial evaluating intravenous (IV) Choline Chloride in patients receiving long-term parenteral support (PS). IV Choline Chloride, the Company's investigational phospholipid substrate replacement therapy, was previously granted Fast Track designation by the U.S. Food and Drug Administration. Patients on PS are unable to synthesize choline from enteral nutrition sources, and there are currently no available PS formulations containing choline. IV choline is recommended for patients receiving PS by the American Society for Parenteral and Enteral Nutrition (ASPEN) in its Recommendations for Changes in Commercially Available Parenteral Multivitamin and Multi-Trace Element Products, as well as by the European Society for Clinical Nutrition and Metabolism (ESPEN) in its Guideline on Home Parenteral Nutrition. About IV Choline Chloride: IV Choline Chloride is an investigational, intravenousospholipid substrate replacement therapy in development for patients receiving PS. Every year in the U.S. there are approximately 90,000 people who require PS at home and of those approximately 30,000 are on long-term PS. IV Choline Chloride has the potential to become the first U.S. Food and drug Administration (FDA) approved IV choline formulation for PS patients. It has been granted Orphan Drug Designation by the FDA for the prevention and/or treatment of choline deficiency in patients on long-term PN and has been granted Fast Track Designation as a source of choline when oral or enteral nutrition is not possible, insufficient, or contraindicated. The U.S. Patent and Tradark Office has issued Protara a U.S. patent claiming a choline composition and a U.S. patent claims a method for treating choline deficiency with a choline composition, each with a term expiring in 2041. Protara may, in some cases, use terms such as "predicts, "bel believes," "pot potential," "proposed," "continue," "designed," "estimates," "ant anticipates," "ex expects," " plans," " plans," "intends," " may," " might," " might," "will," "should" or other words or expressions referencing future events, conditions or circumstances that convey uncertainty of future events or outcomes to identify these forward-looking statements include: risks that Protara's intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things: Protara's business strategy, including its development plans for its product candidates and plans regarding the timing or outcome of existing or future clinical trials (including the timing of any particular phases of such trials and the timing of the announcement of any data produced during such trials or phases thereof); statements related to expectations regarding interactions with the U.S. Food & Drug Administration (FDA); Protara's financial position; statements regarding the anticipated safety or efficacy of Protara's product candidates; and Protara's outlook for the remainder of the year and future periods. Factors that contribute to the uncertainty of the forward-looking statements include: risk that Protara's financial guidance may not be expected, as well as risks and uncertainties associated with: Protara's financial guidance may be expected, as well as risk and uncertainties associated with:Protara's financial position; statements related to the anticipated safety or efficacy of the company's product candidates; and the company's outlook for the remainder of The year and future periods.