Unicycive Therapeutics Secures US Patent for UNI-494 to Treat Chronic Kidney Disease

Unicycive Therapeutics has announced that it has been issued a new U.S. patent for its investigational drug, UNI-494, for the treatment of chronic kidney disease (CKD). This latest patent adds to the company’s intellectual property portfolio, which already includes a patent for the drug’s use in treating acute kidney injury (AKI). According to CEO Dr. Shalabh Gupta, the patent is expected to enhance the drug’s development and potential for future partnerships.

How UNI-494 Works

UNI-494 is a novel nicotinamide ester derivative and a selective activator of the ATP-sensitive mitochondrial potassium channel. Its mechanism of action is based on restoring mitochondrial function, which is often impaired in both CKD and AKI. By doing so, the drug has the potential to not only slow down but possibly reverse the progression of kidney-related diseases. The company notes that the drug has also received an orphan drug designation for the prevention of delayed graft function in patients undergoing a kidney transplant.

Clinical Development and Findings

UNI-494 has successfully completed a Phase 1 clinical study in healthy volunteers. The study demonstrated that a single dose of 10 to 160 mg was safe and well-tolerated. The drug was rapidly converted into a therapeutic compound called nicorandil, and it was found that a dose of 60 mg was sufficient to achieve therapeutic levels.

Earlier research in a different context suggested that a single intravenous dose of UNI-494 could reduce kidney functional markers and tubular injury scores, indicating that the therapy may be able to slow or reverse the progression of established AKI. With these positive Phase 1 findings, the company plans to meet with the FDA to discuss a potential Phase 2 study design to further evaluate UNI-494’s efficacy in patients with AKI.