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Unicycive Initiates Pivotal Clinical Bioequivalence Study of Renazorb to Treat Hyperphosphatemia
On track to complete study by year end 2022 LOS ALTOS, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"On track to complete study by year end 2022\nLOS ALTOS, Calif., June 02, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease today announced the initiation of its pivotal clinical bioequivalence (BE) study of Renazorb® (lanthanum dioxycarbonate.) Renazorb is a novel phosphate binding agent utilizing proprietary nanoparticle technology that is being developed by Unicycive for the treatment of hyperphosphatemia. Unicycive previously received confirmatory guidance from the U.S. Food and Drug Administration (FDA) that this single BE study in healthy volunteers demonstrating the comparability of pharmacological efficacy of Renazorb to the reference listed drug, Fosrenol® would satisfy the requirements for a New Drug Application filing through the 505(b)(2) pathway. \"The initiation of this clinical study is an important milestone for Unicycive that brings us one step closer to advancing this novel phosphate binding agent toward market approval and demonstrates our experienced team’s ability to execute on our development strategy,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. About the BE Study Design The study is a randomized, open label, two-way crossover BE study to establish pharmacodynamic bioequivalence between Renazorb and Fosrenol. The study will enroll 32 individuals per treatment arm for a total of 64 evaluable subjects. The primary endpoint of the study is LS (least Square) mean change in urinary phosphate excretion from baseline to the evaluation period. The study will consist of a screening period, 2 dosing periods, a washout period, and a follow-up period. The Renazorb program is supported by a previously completed clinical trial that studied Renazorb in 32 healthy volunteers. In this study, Renazorb was minimally absorbed to the systemic circulation and was safe and well-tolerated at doses up to 6000 mg/day. Renazorb significantly reduced urine phosphate excretion and significantly increased fecal phosphate excretion at doses at and above 3000 mg/day. The Unmet Need in Hyperphosphatemia Renazorb is intended to be administered as a tablet to be swallowed whole at mealtimes. CKD patients typically have co-morbidities, often requiring them to be on strict pill schedules. Current phosphate binder...