This Phase II study is to explore the feasibility of developing NVC-422 as a product candidate to treat or prevent catheter-associated urinary tract infections (UTI).
In this open-label study, designed to evaluate the activity of NVC-422 in the bladders of patients with bacteriuria, a solution of NVC-422 will be instilled into the catheter and bladder to determine whether NVC-422 can impact pre-existing bacteriuria.
All patients will have levels of bacteria in their bladders that exceed 105CFU/ml. The study is initially exploring the impact of single doses and may subsequently explore the use of multiple doses. Up to 20 patients will be enrolled.
Colin Scott, vice president of clinical R&D at NovaBay, said: “After the successful completion of our Phase I study that demonstrated the safety and tolerability of an NVC-422 solution in the bladder, we are now beginning the exploration of its activity in patients. We expect to learn from this early Phase II study whether NVC-422 may be used to reduce bacteriuria which is seen to be a precursor to symptomatic urinary tract infections that can be very serious for the patient and can significantly increase the costs of hospitalization.”