LOS ALTOS, Calif. – Unicycive Therapeutics, Inc. (NASDAQ: UNCY), a clinical-stage biotechnology company, announced today that its investigational drug UNI-494 received orphan drug designation from the U.S. Food and Drug Administration for the prevention of Delayed Graft Function (DGF) in kidney transplant patients. The designation is aimed at treatments for rare diseases affecting fewer than 200,000 individuals in the United States annually.
UNI-494 is a cytoprotective agent designed to protect cells from ischemia/reperfusion injury (IRI), a significant cause of acute kidney injury leading to DGF, by activating KATP channels in mitochondria. This process is believed to restore mitochondrial function and potentially prevent DGF, a serious complication in the first week after kidney transplantation that can lead to impaired graft function, higher rates of tissue rejection, and decreased patient survival.
The FDA's orphan drug designation provides Unicycive with benefits including tax credits for clinical trial costs, user fee exemptions, and the potential for seven years of market exclusivity upon approval. "Obtaining ODD is an important milestone in the development of UNI-494," stated Shalabh Gupta, MD, CEO of Unicycive.
On March 12, 2024, Unicycive plans to present data on the efficacy of UNI-494 in animal models of DGF and details of the ongoing Phase 1 clinical trial design for the drug at the 29th International Conference on Advances in Critical Care Nephrology AKI and CRRT 2024. The Phase 1 trial is currently underway in the United Kingdom, with completion expected in the second half of 2024.
Unicycive focuses on developing treatments for kidney diseases, with UNI-494 being one of their key investigational drugs, protected by patents in the U.S. and Europe. The company's lead drug candidate, oxylanthanum carbonate (OLC), is being developed for hyperphosphatemia in chronic kidney disease patients on dialysis.
The information in this article is based on a press release statement from Unicycive Therapeutics, Inc.
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