C-1205 Prevention of Catheter-Associated Urinary Tract Infections (CAUTIs)
Urinary tract infections (UTIs) are among the most common type of healthcare-associated infections, resulting in nearly 13,000 deaths each year. Nearly 75% are associated with a urinary catheter.
Atterx has developed C-1205, an innovative product that uses bacterial interference to address the growing problem of CAUTIs. C-1205 replaces the traditional lubricant used to coat urinary catheters prior to their insertion into the patient. C-1205 is a lyophilized (freeze-dried) powder containing a harmless bacterium and a gelling ingredient, that can be stored for many years with no loss of activity. The product is reconstituted with water when needed, forming a thick gel for catheter insertion. Insertion of the catheter into the patient introduces the bacteria into the bladder where it forms a beneficial colony that prevents UTIs.
Cost of hospital-associated UTIs was nearly $3 billion in 2013. Costs are expected to climb to nearly $3 Billion by the end of the 2020, with cost continuing to rise annually.
1.7 million hospital acquired infections annually
36% of hospitals acquired infections are UTIs
80% of UTIs result from catheterization
15,000 - 45,000 deaths
How It Works
C-1205 introduces harmless bacteria into the bladder to prevent urinary tract infections.
C-1205 is a stable freeze-dried preparation that is resuspended with water when needed to produce a thick lubricating gel.
The gel is applied to the urinary catheter prior to it's insertion into the bladder.
C-1205 simultaneously lubricates the catheter and introduces harmless bacteria into the bladder.
These harmless bacteria grow quickly and safely colonize the bladder.
Colonization with our harmless bacteria prevents urinary tract infections caused by other dangerous bacteria and fungi.
Safety and Efficacy Proven in Multiple Clinical Trials
The efficacy of using harmless bacteria in reducing the frequency of CAUTIs has been examined in multiple clinical studies with two different strains of E. coli: E. coli 83972 and E. coli HU2117. C-1205 uses Atterx’s formulation of E. coli HU2117. Colonization of patients with either E. coli 83972 or E. coli HU2117 was found to be extremely safe and effective at reducing the incidence of UTIs.
E. coli 83972
Tested in 152 patients
E. coli HU2117
Tested in 70 patients
Identical to wild-type strain except one gene was deleted
Both strains safely colonize the bladder of patients. Colonized bladder results in significant reduction in CAUTIs.
The FDA has approved a Phase I trial using Atterx C-1205. This will allow rapid entry into a Phase II trial. The Phase I/II trial will involve 40 patients in four groups to confirm the safety of the product.
The trials will determine rates and time to colonize bladder, evaluate maintenance in the bladder after removal, investigate the presence of bacteria in urine, and evaluate the efficacy of C-1205 to prevent infection.