Unicycive Therapeutics announced the issuance of U.S. Patent 12,377,082 by the U.S. Patent and Trademark Office for UNI-494 to treat chronic kidney disease (CKD). This patent extends intellectual property protection until 2040 and follows an earlier method of use patent for treating acute kidney injury with the same compound.
"While we are focused on seeking FDA approval of our lead product oxylanthanum carbonate, we are pleased to announce the issuance of another patent for our second investigational drug, UNI-494," said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. "This patent is part of a broader intellectual property portfolio for UNI-494, which supports potential partnership opportunities and future development efforts."
Novel Mechanism Targets Mitochondrial Dysfunction
UNI-494 represents a novel approach to kidney disease treatment as a nicotinamide ester derivative and selective ATP-sensitive mitochondrial potassium channel activator. The drug's mechanism of action focuses on restoring mitochondrial function, which plays a critical role in the progression of both acute kidney injury and chronic kidney disease.
The compound has received orphan drug designation from the FDA for preventing delayed graft function (DGF) in kidney transplant patients. Unicycive has completed a Phase I dose-ranging safety study in healthy volunteers, establishing the foundation for future clinical development.
Addressing Critical Medical Need
Acute kidney injury presents a significant global health burden, with the condition estimated to occur in 20-200 per million population in the community, 7-18% of hospitalized patients, and approximately 50% of intensive care unit patients. The condition is defined as a sudden loss of kidney function determined by increased serum creatinine levels and decreased urine output, typically limited to seven days duration.
Primary causes of acute kidney injury include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed graft function, a specific type of acute kidney injury, occurs in the first week following kidney transplantation.
The mortality impact is substantial, with an estimated 2 million people dying from acute kidney injury worldwide annually. Survivors face increased risk of developing chronic kidney disease and end-stage renal disease, highlighting the critical need for effective therapeutic interventions.
Expanding Intellectual Property Portfolio
UNI-494 is protected by issued patents in the United States and Europe, with a wide range of patent applications filed worldwide. This comprehensive intellectual property strategy supports the company's development efforts and potential partnership opportunities as the program advances through clinical development.
Unicycive's pipeline includes oxylanthanum carbonate as its lead investigational treatment, a novel phosphate binder for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The company's focus on kidney diseases addresses multiple aspects of renal dysfunction, from acute injury prevention to chronic disease management.
