Unicycive Therapeutics announced positive patient-reported outcomes from a Phase 2 trial of its oxylanthanum carbonate (OLC) drug for hyperphosphatemia in chronic kidney disease patients on dialysis. A concurrent survey by the National Kidney Foundation, sponsored by Unicycive, highlighted the challenges patients face with current phosphate binders, particularly the high pill burden and large pill size. These findings are being presented at the NKF Spring Clinical Meetings.
This news is crucial because it addresses a significant unmet need in the dialysis community. High non-adherence rates with current phosphate binders underscore the need for a more patient-friendly treatment option. OLC’s potential to improve adherence could lead to better phosphate control, ultimately reducing the risk of serious complications like cardiovascular disease and renal osteodystrophy, improving patient outcomes and quality of life.
In the Phase 2 trial, OLC reduced the median daily pill burden by half compared to patients’ prior phosphate binders. A remarkable 79% of patients preferred OLC, with 98% finding it easy to take. The NKF survey confirmed that pill burden and size are major barriers to adherence, reinforcing the potential value proposition of OLC. The FDA has accepted Unicycive’s New Drug Application for OLC, with a target action date of June 28, 2025.
A positive FDA decision could significantly reshape the hyperphosphatemia treatment landscape. OLC offers a compelling alternative to existing therapies, potentially driving improved patient adherence and ultimately better clinical outcomes. This could lead to increased market share for Unicycive and a higher quality of life for patients undergoing dialysis.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
