SR Pharma PLC, of London, announced that the FDA has accepted its Investigational New Drug application (IND) for AKIi-5, a small interfering RNA (siRNA) therapeutic for the prevention of acute kidney injury (AKI) in high-risk patients undergoing major cardiovascular surgery.
The product, which is being developed by Quark Biotech Inc., is based on SR Pharma’s unique proprietary chemistry and is expected to reduce the incidence of post-surgery AKI requiring dialysis as well as AKI-associated mortality.
AKI is associated with a 50%-70% mortality rate in ICU patients and up to 88% in patients who develop it after major cardiovascular surgery. Klaus Giese, PhD, chief scientific officer of SR Pharma, stated, “These developments further demonstrate our ability to design stabilized and highly potent siRNA molecules, based on our own patented siRNA chemistry, which can address specific disease targets.”
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