Developing Auxora for the
Treatment of Acute Kidney Injury
with Respiratory Failure
Auxora™ has the potential to treat severe acute kidney injury (AKI) with respiratory failure and limit morbidity and mortality associated with this disorder, including progression to chronic kidney disease. The rationale for testing Auxora in AKI is based on both human clinical as well as preclinical data. AKI is a common consequence of severe COVID-19 pneumonia and in our severe and critical COVID-19 pneumonia trial (CARDEA), we saw a nearly 40% reduction in reported AKI in Auxora-treated patients as compared to placebo-treated patients who did not have kidney injury at enrollment. Further, a post-hoc analysis of CARDEA patients with compromised kidney function at the time of enrollment showed that Auxora-treated patients had a 63% relative reduction in mortality compared to placebo-treated patients. Consistent with other studies looking at patients with AKI with respiratory failure, placebo patients had a mortality rate of nearly 50%. Biomarker analysis in CARDEA patients was also supportive of an Auxora treatment effect on the kidney and correlated with improved outcomes.
Preclinical studies that support human clinical trials have demonstrated that treatment of rats with AKI with Auxora improved eGFR (estimated glomerular filtration rate, a measure of kidney function) by 61%, decreased infiltration of mononuclear (inflammatory) cells into the kidney by 30%, and reduced mortality versus placebo.
AKI denotes a sudden reduction in kidney function, or the organ’s ability to clean and filter blood, as measured by increased serum creatinine (a cellular waste product) or decreased urine volume. AKI can result as a complication of other serious illnesses such as sepsis, respiratory infections and failure, acute pancreatitis, trauma, surgery and burns. AKI is marked by three distinct phases; the initial injury, the progression or recovery from that injury and the subsequent long-term damage that can result from the initial injury.
AKI is classified as stages 1, 2 and 3 depending on the degree to which kidney function is impaired. In the presence of respiratory failure, stage 2 and stage 3 AKI, both classified as severe, put patients at a 50% or greater risk for death while hospitalized and in the 90 days after discharge. Patients who experience AKI are also at risk for long-term problems and may develop chronic kidney disease and end-stage renal failure. In the United States, there are approximately 1.25 million patients in the ICU each year with stage 2 and 3 AKI and 800K of whom have concurrent respiratory failure. There are currently no approved therapies for AKI.
Auxora targets key pathways driving AKI with respiratory failure
Auxora™: Solving the Unmet
Need for Patients with Acute
Kidney Injury
patients per year in the US with AKI
of these patients have stage 2 or stage 3 (moderate to severe) AKI, of whom 800K also have respiratory failure
- Chronic Kidney Disease
- End-stage Renal Disease
- Dialysis and/or Kidney Transplant
- Death
Auxora targets key pathways driving AKI with respiratory failure
Auxora™: Solving the
Unmet Need for Patients
with Acute Kidney Injury
KOURAGE is a randomized, double-blind, placebo-controlled trial evaluating the safety and efficacy of Auxora in patients with severe acute kidney injury (AKI) with respiratory failure. The study is expected to enroll approximately 150 patients with Stage 2 or Stage 3 AKI with associated respiratory failure, and patients are randomized to receive 5 daily doses of Auxora or placebo. The primary endpoint of the trial will be a hierarchical composite of 30-day mortality, then (among survivors) days alive free of ventilation and dialysis. Secondary endpoints will include mortality, ventilator use, dialysis use, and MAKE-90 (Major Adverse Kidney Events at 90 days), a composite of all-cause mortality, decrease in estimated glomerular filtration rate (eGFR), and the incidence of dialysis.
KOURAGE Phase 2 clinical trial in Acute Kidney Injury
KOURAGE: AKI with Respiratory Failure Phase 2 trial design
For more details on the clinical trial, please click here: A study of Auxora in Patients with Acute Kidney Injury (KOURAGE)
