Finding a new role for a 100-year-old therapy
AKI is a common, serious and often life-threatening complication in hospitalized patients and involves a sudden loss of kidney function. Common causes include trauma, ischemia/reperfusion injury, sepsis and exposure to nephrotoxic drugs. Incidence can be as high as 50% in intensive care units and dialysis is the only FDA only approved treatment. The impacts of AKI are significant, including longer length of stay in the hospital and the development of short and long-term complications that lead to an excess mortality rate of up to 50%.
First introduced in 1922 to treat African sleeping sickness, suramin has never been approved in the U.S. We are developing suramin for the treatment of Acute Kidney Injury (AKI). Suramin is a multifunctional polysulfonated naphthylurea that has been studied in a range of disease states.
Researchers in Dr. Schnellman's lab at the Medical University of South Carolina have demonstrated that suramin reduces neutrophil infiltration, blocks apoptosis of renal tubular epithelium, and stimulates reparative processes in animal models of kidney injury [learn more]. Based on these impressive pre-clinical results and the established safety profile in other patient populations, the FDA has approved a Direct to Phase 2 clinical pathway.
We have initiated a Phase 2 study evaluating the effect of suramin in diuretic-resistant AKI patients. The study is designed to assess the effects of suramin as a potential treatment option to prevent subjects with AKI from progressing to Kidney Disease Improving Global Outcomes (KDIGO) Stage III, dialysis-dependent AKI or death. Top line data is expected in mid-2021.