Urinary tract infections (UTI) are one of the most common infections worldwide and exert a considerable impact on economic and public health resources, substantially affecting quality of life for those afflicted. Catheter Associated UTIs (CAUTI) are defined infection associated with the presence of an indwelling catheter.
Catheterized patients tend to suffer from UTIs much more frequently than most patients. More recent discoveries of bacterial biofilms and their frequency in catheterized patients also help explain the susceptibility of these patients to frequent or recurrent infections largely caused by biofilm forming pathogens.
The prevalence of multidrug-resistant (MDR) bacteria has continued to rise at an alarming rate, especially among Gram-negative organisms, with up to 26% of CAUTIs associated with MDR bacteria. As such, alternative treatment options for patients with serious infections caused by MDR pathogens are needed. Conventional standard of care for CAUTIs often includes lengthy courses of oral or intravenous antibiotics, which can be ineffective and lead to the disruption of the gut microbiome. An effective, local antimicrobial treatment has the potential to improve the outcomes of the over 0.5 million CAUTIs treated per year in the US alone.
Lakewood-Amedex is developing a series of antimicrobial agents that could be infused via a catheter directly into the bladder. The very nature of this rapid, short-term treatment to treat cUTI has the potential to save billions of dollars in hospital stays and lengthy treatments by conventional standard of care antibiotics. Additionally, instillation of the bactericidal solution directly to the site of infection in the bladder has the advantage of minimizing or altogether avoiding systemic antibiotic exposure and side effects. This is especially important to preserve a healthy gut microbiome in this vulnerable patient population.
Lakewood-Amedex plans to begin a Phase 1/2a escalating dose, adaptive arm study in late 2023/ early 2024, following an IND filing earlier that year. An adaptive Phase 2b trial in patients who have evidence of CAUTI is then planned to follow.