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Unicycive Achieves Primary Endpoint in Pivotal Bioequivalence Study of Renazorb
Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol Renazorb’s enhanced product profile features reduced pill burden and small, swallowable
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Renazorb demonstrates pharmacodynamic bioequivalence to Fosrenol Renazorb’s enhanced product profile features reduced pill burden and small, swallowable tablets, which may improve patient compliance On track to file New Drug Application mid-2023 LOS ALTOS, Calif., Dec. 28, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the primary endpoint was met in the Company’s pivotal bioequivalence (BE) study comparing Renazorb to Fosrenol®. Based on the topline results, pharmacodynamic (PD) BE of Renazorb to Fosrenol was established and met the regulatory criteria for PD BE in the healthy volunteer BE study. Renazorb is an investigational phosphate binding agent utilizing proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. If approved, Renazorb may dramatically reduce the pill burden that patients endure with currently available medications. The global market opportunity for treating hyperphosphatemia is projected to be in excess of $2.5 billion in 2022, with the United States accounting for more than $1 billion of that total. Despite the availability of several U.S. Food and Drug Administration (FDA)-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines. Market research indicates that the top reason for this significant unmet medical need is related to the high pill burden, which leads to poor patient compliance. Unicycive previously received confirmatory guidance from the FDA that this single BE study in healthy volunteers would satisfy all clinical regulatory requirements and that no other clinical studies would be required for a New Drug Application (NDA) filing through the 505(b)(2) pathway. Today's positive results are from a randomized, open-label, two-way crossover BE study to establish PD BE between Renazorb and Fosrenol. The study enrolled 40 subjects per treatment arm. The study design, including the dose, primary endpoint, and sample size, was reviewed, and aligned by the FDA before the initiation of the study. \"We are delighted with the successful outcome of our registrational BE study of Renazorb. This is a maj...