Unicycive Therapeutics announced that two presentations related to UNI-494 were presented on March 12, 2024 at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024. The oral presentation, entitled, “Intravenous Administration of UNI-494 Ameliorates Acute Kidney Injury in Rat Model of Delayed Graft Function” was delivered by Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive Therapeutics. Dr. Medicherla presented results from the study evaluating the in vivo efficacy of intravenous UNI-494 in the unilateral renal ischemia-reperfusion rat model of acute kidney injury, which is a well-established model of DGF. In the study, a single IV dose of UNI-494 at 5 mg/kg/IV or 10 mg/kg/IV reduced specific kidney functional markers and tubular injury marker with statistically significant results. Importantly, UNI-494 prevented serum and urinary markers of AKI at 5 mg/kg, and proximal tubular injury scores improved in a dose-dependent manner. The study concluded that UNI-494 is a potential candidate for prevention of DGF and other AKI clinical conditions. The poster, entitled, “UNI-494 Phase 1 Safety, Tolerability and Pharmacokinetics: Trial in Progress” was presented by Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive Therapeutics. The poster describes the ongoing Phase 1 dose-escalating single-center, double-blind, placebo-controlled, randomized clinical trial in healthy volunteers. The trial consists of two parts: Part 1 is a single ascending dose study to determine the maximum tolerated dose; Part 2 is a multiple ascending dose study to understand the effect of multiple doses administered of UNI-494. The trial is designed to evaluate the safety, tolerability, and pharmacokinetics of UNI-494 in healthy subjects. The SAD study was successfully completed, and a dose of 80 mg twice-a-day was carried over to the MAD study which is currently ongoing.
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