Praetego Initiates Clinical Development
Praetego Inc receives FDA acceptance to start human trials with PimoxIV™ for Cardiac Surgery Induced - Acute Kidney Injury (CS-AKI)
DURHAM, N.C., May 01, 2019 /PRNewswire-PRWeb/ -- Praetego Inc. received a green light from the U.S. Food and Drug Administration (FDA) to start human trials with PimoxIV™ for Cardiac Surgery Induced – Acute Kidney Injury (CS-AKI). As an Investigational New Drug (IND), PimoxIV is intended for Chronic Kidney Disease patients who are at elevated risk for CS-AKI. PimoxIV is an infusion administered before, during, and after cardiac bypass surgery to minimize kidney insult. PimoxIV's first trial is a dose escalation study scheduled to start this Spring. This will be followed by a small cardiac surgery trial late in 2019.
AKI is defined as a sudden loss of kidney function. It can lead to chronic kidney disease, dialysis and death. AKI is an expensive and often devastating consequence of hospital care. It is the leading cause of organ dysfunction and death in hospitalized adults. Patients with existing Chronic Kidney Disease have higher rates of dialysis and death. In the case of surgery, AKI can result from cascade of insults known as Oxidative Stress (OS). These insults accumulate and overwhelm normal coping mechanisms. Regardless of the reason for hospitalization, experiencing AKI can significantly impact patient outcomes.
PimoxIV works by reinforcing the body's innate defenses against oxidative stress. It is a chemical actor, circulating in plasma and working outside of cells. PimoxIV is a potent inhibitor of oxidative chemistries. It provides broad protection upstream of the cascade leading to oxidative stress. In preclinical studies treatment with PimoxIV protected the kidneys much better than placebo. PimoxIV is the lead candidate in Praetego's Amadorin platform technology.
Addressing CS-AKI represents a $1.7B annual savings to U.S. healthcare costs. To date there are no FDA approved drugs to address CS-AKI. Says Praetego CEO Pepper Landson, "Kidneys do not like to be hospitalized. Addressing AKI has broad implications for in-patient care. Transitioning from research to development is a major step towards protecting patients."
ABOUT PRAETEGO INC
Praetego Inc is developing novel small molecules to address oxidative stress. Our drug candidates are currently being studied in Acute Kidney Injury, Traumatic Brain Injury, and Diabetic Peripheral Neuropathy. Founded in 2017, Praetego is a privately held developmental stage biotech company. It is located in the Biolabs life science incubator in Durham, NC. Praetego is currently raising a Series A round to fund the development program. http://www.praetego.com
SOURCE Praetego Inc
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