Unicycive Therapeutics to Present Three Posters at the American Society of Nephrology (ASN) Kidney Week 2024

Core Viewpoint - Unicycive Therapeutics, Inc. is set to present three poster presentations at the American Society of Nephrology Kidney Week 2024, showcasing their product candidates aimed at treating kidney disease [1][2]. Group 1: Product Candidates - The three presentations will cover the following topics: - Intravenous UNI-494: This candidate is reported to slow the progression or halt/reverse acute kidney injury when administered after ischemia/reperfusion in rats [3]. - Combination of Oxylanthanum Carbonate and Tenapanor: This combination is shown to lower urinary phosphate excretion in rats [3]. - UNI-494 Phase I Study: This study focuses on the safety, tolerability, and pharmacokinetics of UNI-494 [3]. Group 2: Oxylanthanum Carbonate (OLC) - OLC is a next-generation phosphate binding agent designed for treating hyperphosphatemia in chronic kidney disease patients, utilizing proprietary nanoparticle technology [4]. - The global market opportunity for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion [4]. - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not achieve recommended phosphorus levels [4]. Group 3: Clinical Development - Unicycive is pursuing FDA approval for OLC through the 505(b)(2) regulatory pathway, having conducted two clinical studies involving over 100 healthy volunteers [5]. - A pivotal clinical trial in chronic kidney disease patients on hemodialysis demonstrated favorable tolerability of OLC at clinically effective doses [5]. Group 4: UNI-494 - UNI-494 is a novel nicotinamide ester derivative that acts as a selective ATP-sensitive mitochondrial potassium channel activator, potentially beneficial for treating acute kidney injury and chronic kidney disease [9]. - The Phase 1 dose-ranging safety study for UNI-494 has completed enrollment, with results expected in Q3 2024 [9]. Group 5: Acute Kidney Injury (AKI) - AKI is characterized by a sudden loss of kidney function, with primary causes including sepsis, ischemia, and drug-induced nephrotoxicity [10]. - It is estimated that 2 million people die from AKI globally each year, with survivors at increased risk for chronic kidney disease [10].