Core Insights - Unicycive Therapeutics is presenting patient-reported outcomes data from its pivotal UNI-OLC-201 clinical study on oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis [1][2] - The New Drug Application (NDA) for OLC has been accepted by the FDA, with a target action date set for June 28, 2025 [2][9] - Hyperphosphatemia remains uncontrolled in 75% of U.S. dialysis patients, highlighting a significant unmet need for more effective treatments [3][7] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC as its lead drug candidate [9] - OLC utilizes proprietary nanoparticle technology to reduce pill burden, potentially improving patient adherence [2][5] - The company has a strong global patent portfolio for OLC, with exclusivity until 2031 and potential extension until 2035 [7][9] Market Opportunity - The market for treating hyperphosphatemia is projected to exceed 1 billion [7] - Despite existing phosphate binders, 75% of dialysis patients do not achieve target phosphorus levels, indicating a substantial market gap [7][8] Clinical Study Insights - OLC has shown the potential to reduce pill burden by half, which is a key factor in improving adherence among dialysis patients [6][8] - The upcoming medical meetings will feature abstracts related to the pivotal clinical study, emphasizing the importance of addressing pill burden in treatment [4][6]
Unicycive to Highlight Patient Reported Outcomes Data at Upcoming Medical Meetings Showing Oxylanthanum Carbonate Reduced Pill Burden and Improved Adherence in Treatment of Hyperphosphatemia