Core Insights - Unicycive Therapeutics, Inc. has published a review on phosphate management from patient perspectives, highlighting the challenges and limitations of current therapies [2][3] - The review emphasizes the need for patient-centered approaches to improve clinical outcomes and satisfaction in managing phosphorus levels [2] Company Overview - Unicycive Therapeutics is a clinical-stage biotechnology company focused on developing therapies for kidney disease, with its lead candidate being Oxylanthanum Carbonate (OLC) [10] - OLC is a next-generation phosphate binding agent designed to treat hyperphosphatemia in chronic kidney disease patients on dialysis, characterized by a lower pill burden and better patient compliance [6][10] Market Opportunity - The global market for treating hyperphosphatemia is projected to exceed 1 billion [6] - Despite existing FDA-cleared medications, 75% of U.S. dialysis patients do not achieve target phosphorus levels, indicating a significant unmet need in the market [6] Clinical Development - Unicycive is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway, with a New Drug Application (NDA) submission based on data from three clinical studies and multiple preclinical studies [6][10] - OLC is protected by a strong global patent portfolio, with exclusivity until 2031 and potential extension until 2035 [6][10] Patient Adherence Challenges - Nonadherence to phosphate binders is a significant issue, with rates ranging from 22% to 74%, averaging 51% [8] - Factors contributing to nonadherence include large pill sizes, high pill burdens, and gastrointestinal side effects, underscoring the need for innovative solutions [8]
Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science