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FDA grants fast track status to ASP1128 for patients at risk for AKI
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The FDA has granted fast track designation for development of ASP1128, an investigational compound by Astellas Pharma Inc. for patients at risk of developing acute kidney injury after coronary artery bypass or valve surgery, according to a company press release.
ASP1128, a selective and potent peroxisome proliferator-activated receptor delta modulator that promotes fatty acid oxidation in mitochondria, may have protective effects on kidney cells under cellular stress after coronary artery bypass or valve 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,” Salim Mujais, MD, senior vice president and therapeutic area head of medical specialties at Astellas, said in the release. “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.”
According to the release, pre-clinical data have previously demonstrated the ability of ASP1128 to improve energy metabolism, kidney performance and mitochondrial function after an acute ischemia reperfusion injury. ASP1128 also improved histopathology, injury biomarkers and renal function in AKI animal models. The compound’s potential to reduce local and systemic inflammatory responses and oxidative stress is being explored via a phase 2 study of 220 U.S. patients.