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Unicycive Completes Enrollment of Pivotal Bioequivalence Study for RENAZORB™ (lanthanum dioxycarbonate), an Investigational Treatment for Hyperphosphatemia in Chronic Kidney Disease (CKD) Patients on Dialysis
Topline Data Expected by Year End 2022 On Track to File the NDA in 2023 LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Topline Data Expected by Year End 2022 On Track to File the NDA in 2023 LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today 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. \"The completion of enrollment of this pivotal clinical study is an important milestone for Unicycive, and we look forward to reporting the topline data from this study by the end of this year,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “Based on the results of our pivotal BE study, Unicycive will seek a pre-NDA meeting with FDA subsequently to file the NDA in 2023. We remain confident that an advanced phosphate binder with the unique product profile of RENAZORB will be a welcome option for patients with hyperphosphatemia and represents a significant global market opportunity for Unicycive.” About RENAZORB (lanthanum dioxycarbonate) RENAZORB is an investigational next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with c...