Oxylanthanum Carbonate May Offer Desirable Alternative to Current Phosphate Binders

Unicycive Therapeutics has announced new patient-reported outcomes data from its phase 2 study of oxylanthanum carbonate (OLC) for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis as well as findings from a survey on top barriers to phosphate binder adherence among patients undergoing dialysis.1

Findings were presented during poster sessions at the National Kidney Foundation (NKF) Spring Clinical Meetings and demonstrate patients’ satisfaction with OLC compared to their prior phosphate lowering therapy as well as patient perspectives on the barriers phosphate binder pill size and count pose to consistent medication use.1

An investigational next-generation lanthanum-based phosphate binding agent, OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. In November 2024, the US Food and Drug Administration accepted the New Drug Application (NDA) for OLC and set a Prescription Drug User Fee Act (PDUFA) target action date of June 28, 2025.2

Phase 2 UNI-OLC-201 Patient-Reported Outcome Findings

The open-label, single-arm, multicenter, multidose study enrolled CKD patients on dialysis with mean historical serum phosphate levels between ≥ 4.0 and ≤ 7.0 mg/dL for ≥ 8 weeks. After a phosphate binder washout, patients received OLC 500 mg TID, titrated to a maximum of 1000 mg TID during a 6 week titration followed by 4 weeks maintenance. Patient satisfaction, pill burden, and adherence to their current phosphate binder and OLC were assessed at screening and end-of-study, respectively, using questionnaires.1,3

A total of 86 patients were enrolled, treated with OLC, and responded to the questionnaires. At study entry, the median daily tablet intake for patients’ current phosphate binder was 6 tablets, with 58% of patients reporting adherence to their current phosphate binder.1,3

Among the study cohort, 80 patients completed the end-of-study questionnaire. The median daily tablet intake for OLC was 3 tablets and 70% of patients were adherent to treatment. Of note, 79% of patients indicated they preferred OLC over their current phosphate binder, and 98% of patients agreed that OLC was easy to take versus 38% who said the same about their pre-trial phosphate binder medication. Similarly, 89% of patients indicated satisfaction with OLC versus 49% who were satisfied with pre-trial phosphate binders.1,3

“As many as 2 out of 3 of patients with end-stage kidney disease undergoing dialysis don’t consistently adhere to their phosphate binder treatment; common barriers are side effects, pill burden, and unpalatable formulations,” said Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, PA, and principal investigator for the UNI-OLC-201 trial.1 “These new patient-reported outcomes underscore the potential of OLC to enhance adherence, reduce treatment burden and improve patient satisfaction. OLC could be a welcome new phosphate binder choice for patients with hyperphosphatemia due to its favorable tolerability, small, easy-to-swallow size and low pill burden.”

Survey: Barriers to Phosphate Binder Adherence

To assess patient perspectives on top barriers tp phosphate binder adherence and what treatment characteristics may enhance adherence, Unicycive conducted an online survey in partnership with NKF, leveraging the organization’s email list to recruit dialysis patients ≥ 40 years of age with insurance to complete the 20-minute online survey.1,4

Survey questions assessed pill burden, phosphate binder challenges, factors driving non-adherence, and the impact of binder attributes on adherence. A total of 200 patients completed the survey between February 15, 2024, and May 16, 2024.1,4

Of the 126 patients who responded to the question regarding the largest obstacles to taking phosphate binder medication, forgetfulness (63%) was the primary barrier to consistent medication use, followed by excessive pill number (47%) and large pill size (47%). Additional barriers to adherence ranked by patients included difficulties carrying pills (45%), gastrointestinal side effects (29%), unpleasant taste (20%), social embarrassment when taking medication (13%), and cost (10%).1,4

With the FDA expected to make a decision on OLC in the next 2 months, patient-reported outcomes data from the phase 2 UNI-OLC-201 study and patient survey results indicate high patient satisfaction with OLC and a desire for fewer pills that are easier to take than current phosphate binders.

References

1. Unicycive Therapeutics. 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. April 10, 2025. Accessed April 10, 2025. https://ir.unicycive.com/news/detail/98/unicycive-presents-new-patient-level-data-underscoring

2. Unicycive Therapeutics. Unicycive Therapeutics Announces U.S. FDA Acceptance of the New Drug Application (NDA) for Oxylanthanum Carbonate (OLC) for the Treatment of Hyperphosphatemia in Patients with Chronic Kidney Disease on Dialysis. November 11, 2024. Accessed April 10, 2025. https://ir.unicycive.com/news/detail/88/unicycive-therapeutics-announces-u-s-fda-acceptance-of-the

3. Reddy G, Block GA, Chertow GM. Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence. Poster Presented at: National Kidney Foundation (NKF) Spring Clinical Meetings in Boston, MA. April 10-13, 2025.

4. Gallant KH, Reddy G, Jermasek D, et al. Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients. Poster Presented at: National Kidney Foundation (NKF) Spring Clinical Meetings in Boston, MA. April 10-13, 2025.