Unicycive Therapeutics recently announced positive results from its Phase I trial of UNI-494, [a patented pro-drug of nicorandil which is currently in development for the treatment of acute kidney injury (AKI)]. Its use was shown to be safe and well-tolerated in both single ascending and multiple ascending doses. The trial results also showed that its absorption was fast and rapidly metabolised, and that plasma concentration increases when dose increases.
The ageing global population will lead to an increase in the prevalence of AKI, leading to an expansion of the market as well as a growing need for more therapeutic options. Key opinion leaders interviewed by GlobalData have emphasised that a drug that specifically shows enhanced efficacy in kidney disease patients will most likely receive breakthrough or fast track designations and gain market share.
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UNI-494 exhibits therapeutic intervention activating the SUR2 subunit of the mitochondrial ATP-sensitive potassium channel (KATP channel) [a type of potassium channel that is gated by intracellular nucleotides, ATP and ADP]. It thus reduces oxidative stress and restores mitochondrial function. The Phase I study was a randomised, open-label, double-blind, placebo-controlled, single ascending dose, multiple ascending dose and single-centered study to assess the safety, tolerability and pharmacokinetics of UNI-494. The single ascending dose from 10mg to 160mg was well-tolerated, as was the multiple ascending dose of 40mg twice daily for five days.
AKI can cause a build-up of waste products in the blood and make it difficult to maintain the right balance of fluid and minerals in the body. It can also 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 cases in 2023 to 121,072,673 cases in 2033 across the seven major markets (7MM: France, Germany, Italy, Japan, Spain, the UK and the US).
Unicycive Therapeutics Inc is a biotechnology company that develops novel treatments across multiple therapeutic areas. According to GlobalData’s Pharma Intelligence Center (PIC) drugs database, Unicycive has one other drug in development, RenaZorb (oxylanthanum carbonate) for hyperphosphatemia in CKD. In March 2024, the FDA granted orphan drug designation to UNI-494 for the prevention of delayed graft function after kidney transplantation. Unicycive plans to request a meeting with the US Food and Drugs Administration to review Phase I results and discuss a potential Phase II study for AKI.
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