Source: GlobalData
UNI-494 trial results highlight Unicycive’s potential to differentiate in AKI space, says GlobalData
Posted in Pharma
Unicycive Therapeutics recently announced positive results from its Phase I trial of UNI-494, showing that the drug’s use was observed to be safe and well-tolerated in both single ascending and multiple ascending doses. The trial results also showed that UNI-494 absorption was fast, rapidly metabolized, and plasma concentration increases when dose increases. The drug potentially fills an unmet need in the acute kidney injury (AKI) space as it has an alternate mechanism of action to current marketed therapies, says GlobalData, a leading data and analytics company.
AKI can cause a buildup 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 latest report “Chronic Kidney Disease: Epidemiology Forecast to 2033,” the 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*).
Kajal Jaddoo, Senior Pharma Analyst at GlobalData, comments: “The aging 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.”
UNI-494 exhibits therapeutic intervention activating SUR2 subunit of the mitochondrial ATP-sensitive potassium channel (KATP channel) and thus reduces oxidative stress and restores mitochondrial function.
The Phase I study was a randomized, 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. The multiple ascending dose of 40mg twice daily for five days was also safe and well-tolerated.
Jaddoo concludes: “Key opinion leaders interviewed by GlobalData have emphasized 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.”