BioXell SpA has announced the initiation of a Phase IIa trial to investigate the efficacy of its lead compound BXL628, a non-hypercalcemic vitamin D receptor agonist, in chronic non-bacterial prostatitis (CP/CPPS).
Coordinated by the Division of Urology at the University La Sapienza in Rome, the study will enroll 120 patients in 15 urology centers across Italy. Using a randomized, double-blind, placebo-controlled, parallel group design, the trial's primary objective is to evaluate the effect of BXL628 treatment on the NIH-CPSI (National Institutes of Health - Chronic Prostatitis Symptom Index) total score after 12 weeks of treatment.
CP/CPPS prevalence rates in the general population range from 5 percent to 10 percent, representing the large majority of prostatitis cases and making it a common cause of distress. This disabling condition is characterized by chronic pelvic pain, lower urinary tract symptoms, sexual dysfunction and reduced quality of life. Pain during or after ejaculation is a prominent feature in many patients. Irritative and obstructive voiding symptoms including urgency, frequency, hesitancy, and poor, interrupted flow are also associated with this syndrome in many patients.