TOKYO, October 28, 2019 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the development of ASP1128 for patients at increased risk of developing moderate to severe acute kidney injury (AKI) after coronary artery bypass and/or valve (CABG/V) surgery. The Fast Track designation is intended to facilitate the development, and expedite the FDA review, of drugs to treat serious and life-threatening conditions so that, if approved, the compounds can reach the market more expeditiously.

ASP1128 is an investigational compound that is a potent and highly selective PPARδ modulator. ASP1128 is believed to have protective effects on kidney cells that are under cellular stress following CABG/V surgery by promoting fatty acid oxidation in the mitochondria. Further, ASP1128 may have the potential to reduce systemic and local inflammatory responses and oxidative stress. The 1128-CL-0201 proof of concept Phase 2 study is ongoing. The study design is a randomized, double-blind, placebo controlled study enrolling approximately 220 patients across the United States.

“Following the acquisition of Mitobridge, Inc. in 2018, Astellas is now at the forefront of developing mitochondrial-directed therapeutics. 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.” 

Mike Patane, Ph.D., President of Mitobridge, an Astellas Company located at Astellas’s site in Cambridge, MA, commented, “Mitochondrial dysfunction is now recognized as an important driver in various diseases with high unmet medical need. For the past six years, our team has focused on this research, first as a biotech joint venture with Astellas and now as an integrated global Biopharma. At Astellas, mitochondrial biology is one of our Primary Focus, and this biology platform drives our commitment to bring new biological concepts into the clinic for rapid proof of concept. Developing ASP1128 in AKI is the lead example of this effort and our robust pipeline as this area continues to expand.”


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