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Durect drug reduces severity of symptoms of liver disease in mid-stage study

Durect Corp. said its medicine DUR-928 helped reduce the severity of symptoms in patients with alcoholic hepatitis, a liver disease.

The Cupertino, Calif.-based biopharmaceutical company evaluated intravenously administered DUR-928 in a phase 2a trial of 19 patients with a moderate or severe form of alcoholic hepatitis. The study evaluated three different doses of the drug and the data was compared with historical data from a control group in a University of Louisville study that included patients 15 patients with alcoholic hepatitis.

Results showed that patients treated with DUR-928 had statistically significantly greater reductions in bilirubin since the time treatment began. Bilirubin is a substance made during the normal breakdown of red blood cells. High levels of bilirubin may indicate different types of liver problems.

The drug also showed statistically significantly lower Lille scores when compared to historical data. The Lille model is a medical tool for predicting mortality in patients with alcoholic hepatitis. Patients with a Lille score below 0.45 have an 85% six-month survival rate compared to those with scores above 0.45, who only have a 25% six-month survival rate, according to the company.

DUR-928 was well-tolerated in all patients, and no drug-related serious adverse events were reported at any dose level.

Durect President and CEO James Brown said the company is planning to meet with the U.S. Food and Drug Administration to discuss the design of the next DUR-928 trial in patients with alcoholic hepatitis and the regulatory path for the medicine's approval.