PDL’s HRS Drug Fails

PDL BioPharma’s Phase III study of terlipressin, a vasoactive peptide, did not meet its primary endpoint in the treatment of type 1 hepatorenal syndrome (HRS), a life-threatening complication of advanced liver disease characterized by kidney failure. In this study, the primary endpoint was treatment success, defined as the percentage of patients alive at Day 14 who demonstrated reversal of type 1 HRS, without dialysis or recurrence of disease. The data showed a positive trend toward treatment success, but did not reach statistical significance.

“We are disappointed that the trial of terlipressin did not meet its primary endpoint, as there is a substantial unmet need in HRS,” said Steven Benner, M.D., chief medical officer, PDL. “We will work with Orphan Therapeutics to further analyze the study results.”

PDL obtained U.S. commercial rights to terlipressin following its acquisition of ESP Pharma in March 2005.