The Food and Drug Administration (FDA) has granted Fast Track designation to ASP1128 (Astellas Pharma), an investigational treatment for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery.
ASP1128 is a highly selective PPARδ modulator and is believed to work by promoting fatty acid oxidation in the mitochondria, thereby providing a protective effect on kidney cells under cellular stress. “Mitochondrial dysfunction is now recognized as an important driver in various diseases with high unmet medical need,” said Mike Patane, PhD, President of Mitobridge, an Astellas Company. Preclinical data showed that in animal models, treatment with ASP1128 led to improvement in renal function, histopathology, and injury biomarkers.
The efficacy of postsurgery treatment with ASP1128 is currently being evaluated in a phase 2 trial involving 220 patients at risk for AKI following CABG/V surgery. The primary outcome measure of the study will be the proportion of patients developing acute AKI based on serum creatinine criteria within 72 hours; development of AKI will be based on serum creatinine criteria from the Kidney Disease: Improving Global Outcomes (KDIGO) guidelines (ie, increase in serum creatinine ≥0.3mg/dL [≥ 26.5μmol/L] within any 48 hours, or increase in serum creatinine to ≥1.5 times baseline within 72 hours after the end of surgery).
“Today’s announcement is an exciting advancement in an entirely new therapeutic modality and approach with the potential to treat patients with AKI, an area of high unmet need,” said Salim Mujais, M.D., Senior Vice President and Therapeutic Area Head, Medical Specialties, Astellas. “Astellas recognizes the serious burden of AKI on patients and we are pleased that the FDA also acknowledges this unmet need and has granted the Fast Track designation for ASP1128.”
Fast Track designation expedites the FDA review of drugs to treat serious and life-threatening conditions.
For more information visit Astellas.com/us.