The company currently has agreements with 60 investigational sites in the US for Phase III trials of NX-1207, and expects the number of clinical trial sites to be increased to up to 100 investigational sites. The most experienced benign prostatic hyperplasia (BPH) clinical research centers and many of the largest urology practices in the US will be participating.
The Phase III trials for NX-1207 will test the safety and efficacy of the drug treatment of BPH as compared to placebo. Efficacy will be determined by symptomatic improvement, using the American Urological Association BPH symptom index, which measures the severity of the irritative and obstructive urinary symptoms of BPH, including frequency, urgency, intermittency, hesitancy, sensation of incomplete voiding, weak stream, and nocturia.
The trials will also investigate the drug’s effect on prostate volume, urinary maximum flow rate, and several other pertinent measurements.