"We are excited that the first trial of DUR-928 in AH patients demonstrated superior outcomes compared to historical control data," DURECT President and CEO James E. Brown said in the release.
The results show that all 19 patients treated with DUR-928 had "statistically significantly greater reductions from baseline in bilirubin (days 7 and 28) and model for end stage liver disease (MELD) (day 28), as well as statistically significantly lower Lille scores, compared with a historical control group (n=15) from a University of Louisville AH study," the release noted. Of the 19 total enrollees, 12 had severe AH and the remaining 7 had moderate AH.
The lower a patient's Lille score is, the better their prognosis. Generally, a Lille score below 0.45 represents an 85% six-month survival rate. A Lille score above 0.45 tends to be associated with a 25% six-month survival rate.
In DURECT's study, the median Lille score for the 18 AH patients treated with DUR-928 who returned for their Day 7 visit was 0.10; 89%, or 16 out or 18, had a Lille score under 0.45. In comparison, 53%, or 8 out of 15, patients in the University of Louisville study had a Lille score below 0.45. Those patients were treated with either supportive care or supportive care plus corticosteroids, and their median Lille score was 0.41.
As for safety in DURECT's study, all patient tolerated DUR-928, and none reported any associated adverse events at all dose levels tested.
Going forward, DURECT will continue its analysis of the clinical data and report on it at the upcoming annual meeting of the American Association for the Study of Liver Diseases later this year, in November. The biopharma also intends to meet with the U.S. Food and Drug Administration to discuss the design of its next DUR-928 AH clinical trial and the regulatory path to approval.
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