NovaBay Pharmaceuticals announces that data from a Phase 2b clinical study with Auriclosene Irrigating Solution (AIS) demonstrated statistically significant and clinically meaningful results in the prevention of urinary catheter blockage and encrustation in subjects with chronic indwelling urinary catheters who have repeat history of blockage.
Auriclosene is NovaBay’s proprietary, non-antibiotic, fast-acting, broad-spectrum antimicrobial that has exhibited the potential for rapid decolonization of a range of urologic pathogens.
Auriclosene has been designated as a new chemical entity and granted composition of matter patent protection to 2028 by the U.S. Patent Office.
“Of the approximately 300,000 patients in the U.S. with indwelling catheters, about 100,000 chronically suffer from blockage and encrustation. We estimate the healthcare costs to manage these patients in the billion dollar range,” said Mark M. Sieczkarek, Chairman, President and CEO of NovaBay. “
In the parallel design, two-arm Phase 2b study, 36 subjects with chronic indwelling catheters, including those with spinal cord injuries and other neurological conditions such as multiple sclerosis, were treated twice weekly for four weeks with either AIS or Vehicle Solution (citric-acid buffer).
This study was designed to provide a stringent test of the ability of AIS to prevent urinary catheter and blockage because the Vehicle Solution itself has activity in minimizing encrustation. Standard of care for catheter irrigation is saline solution, which has no activity against biofilm and crystalline encrustation.
At the end of the treatment period, catheter flow rate measurements based on an ASTM FDA-recognized standard from both study arms were compared with flow measurements from identical new catheters in a blinded evaluation. The primary efficacy endpoint comparing percent flow rate reduction of AIS-treated catheters to vehicle-treated catheters was achieved with statistical significance (p values < 0.05).
The clinical efficacy endpoint was also achieved with statistical significance, with no blockage in subjects in the AIS arm versus clinical blockage in 28% of the subjects treated with vehicle. There were no serious adverse events reported in the study and auriclosene was generally well tolerated.
On September 16, 2013, NovaBay reported positive results with AIS in a Phase 2 study in the same patient population treated in the Phase 2b study. Results of the Phase 2 study showed that irrigation with AIS was effective in preventing catheter encrustation and blockage compared with irrigation with saline solution. Saline has no activity against biofilm and crystalline encrustation.
The Phase 2 study differed from the Phase 2b study in its crossover design with efficacy assessed by laboratory measurement of catheter blockage.
Each subject served as his/her own control having catheters treated alternatively with AIS and saline solution following a washout period. For 14 per-protocol subjects, comparison of percent encrustation of catheters treated with AIS and saline showed a significant reduction in favor of AIS (Wilcoxon signed-rank test p value < 0.001). No serious adverse events were reported, and overall tolerability was considered good.
Chronic indwelling urinary catheterization is necessary for patients with spinal cord injuries, multiple sclerosis, strokes or other neurogenic bladder conditions.
In these patients catheters repeatedly become coated with bacteria and bacterial biofilm, which may produce localized crystal deposits and may build up and block the catheter. Major medical problems can follow.
The severe consequences of urinary catheter blockage and encrustation are often underappreciated. Catheter blockage can result not only in urinary tract infections and socially embarrassing urine leakage around the catheter, but also frequent use of emergency services and, in those with high-level spinal cord injuries, potentially life-threatening autonomic dysreflexia.