Astellas Announces U.S. FDA Fast Track Designation for ASP1128 in Patients at Risk of Moderate-to-Severe Acute Kidney Injury Following CABG/V Surgery

Fast Track Designation (FTD) aims to accelerate drug development and expedited review for serious diseases, addressing critical areas of unmet medical needs. When an investigational drug receives Fast Track designation, it means that pharmaceutical companies can engage in more frequent interactions with the FDA during the research and development phase. If relevant criteria are met after submission of a marketing application, the drug may qualify for accelerated approval and priority review. Additionally, it is eligible for rolling review.

Acute kidney injury (AKI) is a sudden loss of renal function that commonly occurs in patients hospitalized for cardiac and/or vascular surgery, trauma, infection, heart disease, or nephrotoxic anticancer therapy. AKI occurs in up to 30% of patients undergoing cardiac surgery. Of those with cardiac surgery-associated AKI, 2%–6% require dialysis. Currently, there are no pharmacological agents available for the prevention or treatment of AKI. Clinical manifestations are partly attributable to early-onset mitochondrial dysfunction, which drives various pathophysiological events leading to AKI and appears to be associated with the severity of AKI and its progression to chronic kidney disease (CKD).

ASP1128 is a potent, highly selective PPARδ modulator and a potential first-in-class therapy for the treatment of AKI. ASP1128 is believed to exert protective effects on renal cells under cellular stress following CABG/V surgery by promoting mitochondrial fatty acid oxidation. Furthermore, ASP1128 may have the potential to reduce systemic and local inflammatory responses and oxidative stress.

Preclinical data indicate that intervention with ASP1128 following acute ischemia-reperfusion injury improves mitochondrial function, overall energy metabolism, and renal performance. In animal models of acute kidney injury (AKI), ASP1128 improved renal function, histopathology, and injury biomarkers. Currently, the proof-of-concept Phase II study 1128-CL-0201 is ongoing; this is a randomized, double-blind, placebo-controlled trial enrolling approximately 220 patients in the United States.

Original Source: U.S. FDA Grants Fast Track Designation to Astellas for the Development of ASP1128 for Patients at Risk for Acute Kidney Injury