Unicycive Therapeutics, Inc. announced that two posters related to the Company's lead product candidate, oxylanthanum carbonate (OLC), were presented at the National Kidney Foundation (NKF) Spring Clinical Meeting. OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD). OLC demonstrated a well-tolerated safety profile with no serious adverse events.

This data is important as it serves as one of the key components for New Drug Application filing with the FDA under the 505(b)(2) regulatory pathway. The findings of the survey concluded that strategies that reduce pill burden and increase ease of use for patients are needed, reinforcing the belief that, if approved, the characteristics of OLC including the reduction of pill volume may increase compliance and improve the quality of life for patients living with this condition. Results: The poster presentation described the results of the randomized, crossover bioequivalence study compared OLC with lanthanum carbonate (LC).

The study was a Phase 1, single-center, randomized 1:1, open-label, controlled, 2-way crossover study designed to demonstrate the pharmacodynamic (PD) equivalence between two phosphate binders: orally administered OLC as compared to LC. Both treatments were administered at doses of one 1, 1,000 mcg tablet three-times-a-day (TID) in healthy volunteers who received the same standardized meals to control for daily phosphate intake. One-third of dietitians attributed non-compliance with patients recalling to take their PBs with meals or snacks and 16% attributed it to high pill burden.

Oxylanthanum carbonate is a next-generation lan thanum-based phosphate binding agent using proprietary nanoparticle technology being develop for the treatment of hyperph phosphatemia in patients with chronic renal disease (CKD).