BioXell Initiates Phase IIa Trial of its Lead Compound BXL628 in Chronic Non-Bacterial Prostatitis
BioXell SpA announced the initiation of a Phase IIa trial to investigate the efficacy of its lead compound BXL628, a non-hypercalcemic vitamin D Receptor (VDR) 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 centres 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 5-10%, representing the large majority (90%) 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.
Current therapeutic options - including antibiotics, alpha blockers, non-steroidal anti-inflammatory drugs and finasteride - are unsatisfactory or ineffective, and no surgical procedure has been shown to be effective. Much effort is consequently being dedicated to identifying and developing novel medical approaches for this condition, which represents an important unmet medical need.
The pathogenesis of CP/CPPS is still poorly understood, although substantial evidence indicating an autoimmune component in its pathogenesis has recently emerged. Based on the inhibitory activity of BXL628 on prostate cell proliferation, along with the anti-inflammatory properties of this VDR agonist, scientists at BioXell have tested its ability to treat experimental autoimmune prostatitis.
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