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Scientists report first therapeutic success with new bile acid
Primarily sclerosing cholangitis mainly affects younger people between the ages of 30 and 40 and is currently an incurable liver disease. In a current European multicenter phase II study under the direction of MedUni Vienna and in close cooperation with the Medical University of Graz and the Medical University of Hanover (MHH), the disease can now be cured for the first time with the help of a synthetically produced bile acid (active ingredient nor-ursodeoxycholic acid / Nor-Urso) succeeded.
So far, primary sclerosing cholangitis has remained one of the last big "black boxes" in hepatology, "one of the last unsolved mysteries", says study leader Michael Trauner, head of the clinical department for gastroenterology and hepatology at MedUni Vienna in a press release on the study results. If the healing based on artificial bile acid "Nor-Urso succeeds, it would be a remarkable breakthrough in hepatology", emphasizes Trauner. The researchers published their results in the journal "Hepatology".
Incurable liver disease with poor prognosis
The current study was based on data from 161 patients with primary sclerosing cholangitis from 45 treatment centers in twelve countries (Austria, Germany, Belgium, Denmark, Great Britain, Hungary, Lithuania, Holland, Norway, Spain, Finland and Sweden). So far, the prognosis for incurable rare liver disease has been very poor, as liver cirrhosis and bile duct cancer can develop in the further course. The disease is characterized by a disorder in bile production and affects 0.01 percent of the population, according to the MedUni Vienna.
Significant improvements in liver function tests
In their current study, the scientists test the use of synthetic bile acid in the treatment of primary sclerosing cholangitis - with success. "There were significant improvements in liver function tests in all doses tested," reports study leader Trauner. This is a promising result. “This means that a phase III study can now be started that also examines the long-term effects on disease progression,” continues Trauner.
Synthetic bile acid clinically effective, safe and well tolerated
According to the researchers, Nor-Urso proved to be clinically effective, safe and well tolerated in the study. The synthetic bile acid acts directly on the bile duct and flushes the bile ducts free of toxins by increasing the bicarbonate-rich bile flow. "The active ingredient circles between the bile and liver and works exactly where the inflammatory processes take place, namely directly in the bile duct," emphasizes the study leader.
Phase III trial planned
According to the researchers, the current results suggest that Nor-Urso can also help stop liver fibrosis and improve connective tissue. This must now be examined in a phase III clinical study. This will take around three years and if the result is positive, the previously incurable primary sclerosing cholangitis could be treated with synthetic bile acid. (fp)