Sophiris Bio Inc. announced findings from an administrative interim analysis of efficacy in its ongoing Phase 3 "PLUS-1" trial of PRX302 as a treatment for lower urinary tract symptoms of BPH. The Independent Data Monitoring Committee (IDMC) reported that a predefined efficacy threshold following treatment was not achieved. This administrative interim analysis was conducted specifically for planning subsequent clinical trials.

The ongoing "PLUS-1" study is unaffected by this recommendation, and all patients in the study will continue to be followed to enable the evaluation of the primary efficacy endpoint at 52 weeks.