STOCKHOLM--(BUSINESS WIRE)--Regulatory News:
Wilson Therapeutics AB (publ) (STO:WTX), announces that preliminary data from the company’s ongoing Phase II clinical trial for Decuprate® (bis-choline tetrathiomolybdate; WTX101) in Wilson Disease will be presented today at the 20th International Congress of Parkinson´s Disease and Movement Disorders, taking place in Berlin, Germany, June 19-23. The poster presentation of the data will be provided by Prof. Anna Czlonkowska. The underlying data have previously been presented at the Congress of the European Academy of Neurology on May 30.
WTX101-201 is a Phase II clinical trial evaluating the efficacy and safety of Decuprate® monotherapy dosed once daily in 28 newly-diagnosed patients with Wilson Disease, aged 18 years and older, who are previously untreated or have received a standard of care agent for up to two years. The study is being conducted at 11 sites in the U.S. and Europe, and will follow patients on Decuprate® for 24 weeks. Patients completing the 24 weeks can elect to stay on Decuprate® in an extension phase of the study.
The last patient was enrolled in the trial on May 18 and as of June 23, ten patients have reached the end of the 24-week treatment period. All ten patients have elected to continue Decuprate® treatment in the extension phase. The patients recruited had various degrees of hepatic impairment at the time of enrollment and the majority of enrolled patients also had neurological symptoms at study start.
About Decuprate® (bis-choline tetrathiomolybdate; WTX101)
Decuprate® is a first in class, specific Copper-Protein Trap under investigation as a novel therapy in Wilson Disease. Decuprate®, unlike current treatments for Wilson Disease, appears to have direct activity in the liver where it specifically targets and reduces toxic free copper. Decuprate® also reduces toxic free copper in the blood, and then excretes it via the bile, the body’s natural route for excess copper elimination. The active ingredient of Decuprate®, tetrathiomolybdate, has been tested in several clinical studies in Wilson Disease patients and the data from these studies, as well as preliminary data from the Company’s ongoing Phase II study, suggest that Decuprate® can rapidly lower and control toxic free copper levels and improve clinical symptoms in these patients. The data also suggest that Decuprate® is well-tolerated with the potential for a reduced risk of neurological worsening after initiation of therapy compared to existing therapies. Decuprate® is expected to have a once-daily dosing regimen which may potentially translate into improved compliance in Wilson Disease patients, leading to fewer treatment failures and ultimately improved outcomes as a result. Decuprate® has received orphan drug designation for the treatment of Wilson disease in the US and EU.
About Wilson Disease
Wilson Disease is a rare genetic disease that causes serious copper poisoning. The genetic defect causes excessive copper accumulation, primarily in the liver and/or the central nervous system and the disease results in life-threatening damage to the liver and brain if left untreated. Wilson Disease affects approximately one in every 30,000 people worldwide, corresponding to a prevalence of approximately 10,000 patients in the US and 15,000 patients in the EU. The therapies currently being used in Wilson Disease were introduced in the 1950’s and 60’s and since then there have been no new treatment options developed for patients with this disease.
About Wilson Therapeutics
Wilson Therapeutics is a biopharmaceutical company, based in Stockholm, Sweden, that develops novel therapies for patients with rare diseases. Wilson Therapeutics’ lead product, Decuprate®, is initially being developed as a novel treatment for Wilson Disease and is currently being evaluated in a Phase II clinical study. Wilson Therapeutics is listed in the Mid Cap segment on Nasdaq Stockholm with the stock ticker WTX.
Visit www.wilsontherapeutics.com for more information.
Wilson Therapeutics AB (publ)
Org nr 556893-0357
Västra Trädgårdsgatan 15
SE-111 53 Stockholm
The information in the press release is such that Wilson Therapeutics is required to disclose publicly in accordance with the Swedish Securities Market Act. The information was submitted for publication on June 23, 2016 at 8:00 a.m.
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