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Wilson Therapeutics Announces Successful Filing of U.S. IND to Advance WTX101 Development Program for Wilson Disease
Date:1/13/2014

STOCKHOLM, Jan. 13, 2014 /PRNewswire/ -- Wilson Therapeutics, a privately-held biopharmaceutical company, today announced that it has successfully filed an Investigational New Drug (IND) application with U.S. Food and Drug Administration for the development of WTX101 (bis-choline tetrathiomolybdate), a novel de-coppering agent under evaluation as a treatment for Wilson Disease. The recent acceptance of the U.S. IND is a key initial step in the company's plan to advance WTX101 into pivotal clinical trials as a treatment for Wilson Disease, a rare genetic disorder that prevents the body from regulating copper and can lead to serious liver and brain damages.

"This IND enables us to proceed with a Phase 1 study that will provide additional pharmacokinetic and bioavailability data to support the overall development of WTX101 as it moves towards late stage, pivotal trials," said David Clark, M.D., chief medical officer of Wilson Therapeutics. "We expect to conduct this study quickly as we advance the WTX101 program forward this year."

WTX101 is the proprietary bis-choline formulation of tetrathiomolybdate (TTM), which has been evaluated in clinical studies in over 500 patients in various indications. TTM has been shown to rapidly lower copper levels. Previous data also suggest that TTM may stabilize neurological function and reduce the risk of neurological deterioration after initiation of treatment in Wilson Disease patients with neurological disease. WTX101 has also been tested in oncologic clinical trials and was shown to be safe and tolerable while efficiently lowering copper levels with once-daily dosing. WTX101 has received orphan drug designation in both the United States and the European Union.

"There remains a serious unmet need in the treatment of Wilson Disease patients, particularly those who present wit
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SOURCE Wilson Therapeutics
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