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. Complicated UTIs (cUTI) are defined as an infection associated with a condition (such as a structural or functional abnormality of the genitourinary tract) or the presence of an underlying disease.
Catheterized patients tend to suffer from cUTIs 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 cUTIs 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 cUTIs 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 1 million cUTIs treated per year in the US alone.
Lakewood-Amedex has developed an antimicrobial agent Nu-8, to be infused via a catheter directly into the bladder. Nu-8 directly depolarizes bacterial cell membranes, and as such, its bactericidal action is extremely rapid and dramatic. The very nature of this rapid, single 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.
Preclinical studies have demonstrated no emergence of bacterial resistance to the activity of Nu-8. In an environment where multidrug-resistant organisms are common in patients with recurrent cUTI, Nu-8 appears to possess an ideal profile to treat an increasingly common clinical condition that costs healthcare systems many billions of dollars worldwide.
Lakewood-Amedex plans to begin a Phase 1/2a escalating dose, adaptive arm study in H2 2019, following an IND filing earlier that year, expecting topline clinical data to be available by H2 2020. An adaptive Phase 2b trial in patients who have evidence of cUTI is then planned to follow.