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Unicycive Therapeutics Delivers Both an Oral and Poster Presentation on UNI-494 at the AKI and CRRT Conference

Published: 2024-03-13 11:03:00 ET

– Promising Preclinical Results in Delayed Graft Function of Acute Kidney Injury –

– UNI-494 Phase 1 Single Ascending Dose Portion of Clinical Trial Complete –

LOS ALTOS, Calif., March 13, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today 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.

“We are excited about the tremendous progress we have made with our second clinical development asset, UNI-494,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Last week we announced that UNI-494 has been granted orphan drug designation by the FDA for the prevention of delayed graft function (DGF) after kidney transplantation which is a meaningful milestone for the program. The data presented at the CRRT conference demonstrates statistically significant results for UNI-494 in a preclinical model of DGF which provides additional evidence that UNI-494 may be a valuable asset for prevention of DGF and other acute kidney injury clinical conditions.”

“In conjunction with these presentations, we are also excited to announce that our ongoing Phase 1 clinical trial in UNI-494 has successfully completed the single ascending dose (SAD) portion of the study. UNI-494 was well-tolerated up to 160 mg administered as a single dose. This dose was chosen as the go-forward dose based on promising safety, tolerability, and pharmacokinetic data. In the multiple ascending dose (MAD) portion of the study, 80 mg is now being administered twice-a-day to participants enrolled in the study. We expect to complete the Phase 1 trial and report the full results in the second half of this year,” concluded Dr. Gupta.

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 (IV) UNI-494 in the unilateral renal ischemia-reperfusion rat model of acute kidney injury (AKI), 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 (p

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