Rhucin meets Ph III HAE study endpoint

Dutch biotehnology firm Pharming NV has reported positive safety and efficacy data from a European randomized placebo-controlled Phase III clinical trial of its recombinant human C1 inhibitor, Rhucin, for the acute treatment of hereditary angioedema. According to the firm, the positive results from an interim analysis of the evaluation follow earlier studies showing the strong positive effect of Rhucin coupled with an excellent safety profile.

In the Phase III double-blind, placebo-controlled, 28-patient study, participants on Rhucin reported the onset of relief at a median time of 60 minutes after administration compared to 8.5 hours for those who received placebo. The primary endpoint, time-to-beginning of symptom relief, achieved statistical significance (p=0.0009) as measured by the log-rank test. In addition, subjects on Rhucin reported minimal symptoms at a median time of 6.1 hours, which compares favorably with the 20.2 hours experienced by subjects in the placebo cohort.