Unicycive Therapeutics, Inc. announced that it has completed the enrollment of subjects in the RENAZORB bioequivalence (BE) study. RENAZORB (lanthanum dioxycarbonate) is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis. The study is a randomized, open-label, two-way crossover BE study to establish pharmacodynamic bioequivalence between RENAZORB (lanthanum dioxycarbonate) and Fosrenol® (lanthanum carbonate)—the reference listed drug (RLD).

Unicycive previously received confirmatory guidance from the U.S. Food and Drug Administration (FDA) that this single BE study in healthy volunteers would satisfy the requirements and that no other clinical studies are required for a New Drug Application (NDA) filing through the 505(b)(2) pathway. The study enrolled 40 subjects per treatment arm (a total of 80 subjects enrolled) for 64 evaluable subjects. The study design, including the dose, primary endpoint, and sample size, was reviewed by, and aligned with the FDA before the initiation of the study.

The primary endpoint of the study is LS (least square) mean change in urinary phosphate excretion from baseline to the evaluation period.