Unicycive Presents New Patient-Level Data Underscoring Challenges Faced with Current Phosphate Binders and Highlighting the Potential of Oxylanthanum Carbonate to Address Barriers to Adherence for Patients with Hyperphosphatemia on Dialysis

Core Insights - Unicycive Therapeutics announced new patient-reported outcomes data from its pivotal Phase 2 study of oxylanthanum carbonate (OLC), an investigational treatment for hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis, which will be presented at the NKF Spring Clinical Meetings [1][4] - OLC utilizes proprietary nanoparticle technology to reduce the number and size of pills, addressing adherence issues in dialysis patients [2][8] Patient-Reported Outcomes - The Phase 2 trial demonstrated high patient satisfaction with OLC compared to prior phosphate binders, with 98% of patients finding OLC easy to take and 89% satisfied with the treatment [6][7] - OLC reduced the pill burden by 50%, with patients taking a median of three tablets per day compared to six tablets of previous phosphate binders [7] Adherence and Preferences - 70% of patients reported consistent adherence with OLC, an increase from 58% adherence to their previous phosphate binders [7] - 79% of patients preferred OLC over their prior medications, highlighting the impact of pill burden on treatment adherence [7][13] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed $2.28 billion, with North America accounting for over $1 billion [8] - Despite existing treatments, 75% of U.S. dialysis patients do not achieve target phosphorus levels, indicating a significant unmet need in the market [8] Regulatory Status - Unicycive is seeking FDA approval for OLC with a PDUFA Target Action Date set for June 28, 2025, through the 505(b)(2) regulatory pathway [2][9]