Sophiris Bio Inc. announced that it has fully enrolled its ongoing Phase 3 trial (referred to as PLUS-1) of PRX302 as a treatment for lower urinary tract symptoms of BPH. The PLUS-1 trial is an international, multi-center, randomized, double-blind and vehicle-controlled Phase 3 study that will assess the safety and efficacy of a single intraprostatic administration of PRX302 (0.6 ug/g prostate) for the treatment of BPH. The primary endpoint is the International Prostate Symptom Score (IPSS) total score change from baseline over 52 weeks.

Secondary endpoints include Qmax (maximum urine flow) change from baseline over 52 weeks. BPH is an enlargement of the prostate gland, often resulting in a constricted or partially blocked urethra that can lead to frequent and difficult urination, discomfort, and other complications with urinating. It is estimated that more than five million men in the United States alone are bothered by symptoms of BPH.

Current oral drugs for BPH, which are taken daily, often lack sustainable efficacy and may be associated with undesirable side effects including sexual dysfunction. More aggressive treatment options include invasive surgical procedures, which may also cause sexual dysfunction.