Business
Unicycive Announces Full Year 2021 Financial Results and Provides Business Update
On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in first half of 2022 Plans to initiate Phase
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"On track to initiate clinical bioequivalence study of Renazorb to treat hyperphosphatemia in healthy volunteers in first half of 2022 Plans to initiate Phase 1 study for UNI-494 in second half of 2022 LOS ALTOS, Calif., March 31, 2022 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical stage biotechnology company developing therapies for patients with kidney disease, today announced its financial results for the full year ended December 31, 2021 and provided a business update. “The considerable progress we made throughout 2021 puts us in a strong position to execute on our strategy to advance our clinical development programs to address two important renal diseases where current treatment options are suboptimal,” said Shalabh Gupta, M.D., Chief Executive Officer. “Central to our progress was the confirmatory regulatory guidance we received from the U.S. Food and Drug Administration (FDA) regarding the path to marketing approval for our lead product candidate, Renazorb. We are delighted the FDA affirmed its guidance to enable us to pursue the 505(b)2 regulatory pathway, which we believe will significantly reduce the clinical timelines and expense for bringing this enhanced hyperphosphatemia therapy to chronic kidney disease patients seeking new treatment options for this continually challenging condition. \"We have an exciting year ahead at Unicycive as we advance our late-stage program in hyperphosphatemia, initiate first-in-human studies of our earlier stage program with UNI-494 in Acute Kidney Injury and strive to achieve a number of potentially value-creating milestones,” concluded Dr. Gupta. Recent Highlights Received additional confirmatory guidance on the regulatory pathway for Renazorb (lanthanum dioxycarbonate) from the FDA following a Type C meeting in early March in which the FDA confirmed previous guidance that Unicycive may support the New Drug Application (NDA) filing of Renazorb through a 505(b)(2) pathway based on a single clinical bioequivalence (BE) study in healthy volunteers, along with the previously agreed-upon 6-month mouse toxicology study.An agreement was reached with the FDA on the clinical study design including the dose of Renazorb and Fosrenol, sample size and the primary endpoints of the bioequivalence study. The primary endpoint of the study is LS mean change in urinary phosp...