Unicycive Therapeutics has announced positive results from its Phase I trial of UNI-494, a patented pro-drug of nicorandil, currently in development for the treatment of acute kidney injury (AKI). The trial demonstrated that UNI-494 was safe and well-tolerated in both single ascending and multiple ascending doses, marking a significant step forward in addressing this critical medical need.
The Phase I study was a randomized, open-label, double-blind, placebo-controlled, single ascending dose, multiple ascending dose, and single-centered study. It was designed to assess the safety, tolerability, and pharmacokinetics of UNI-494. The single ascending doses, ranging from 10mg to 160mg, were well-tolerated, as was the multiple ascending dose of 40mg twice daily for five days. The results also indicated rapid absorption and metabolism of the drug, with plasma concentration increasing as the dose increased.
Rising AKI Prevalence Drives Need for New Therapies
The aging global population is expected to drive an increase in the prevalence of AKI, leading to a growing demand for more therapeutic options. AKI can lead to a build-up of waste products in the blood and disrupt the balance of fluids and minerals in the body. In severe cases, it can cause permanent kidney damage, leading to chronic kidney disease (CKD). According to GlobalData’s Chronic Kidney Disease: Epidemiology Forecast to 2033 report, total prevalent cases of CKD are expected to increase from 110,299,913 in 2023 to 121,072,673 in 2033 across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK, and the US).
UNI-494 Mechanism and Regulatory Status
UNI-494 exerts its therapeutic effect by activating the SUR2 subunit of the mitochondrial ATP-sensitive potassium channel (KATP channel), a type of potassium channel gated by intracellular nucleotides, ATP, and ADP. This activation helps reduce oxidative stress and restore mitochondrial function. In March 2024, the FDA granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation.
Unicycive's Plans for Future Development
Unicycive Therapeutics plans to request a meeting with the US Food and Drug Administration to review the Phase I results and discuss a potential Phase II study for AKI. Unicycive Therapeutics Inc. is also developing RenaZorb (oxylanthanum carbonate) for hyperphosphatemia in CKD.
