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Unicycive Therapeutics Announces Enrollment of First Patient in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC) in Patients with Chronic Kidney Disease on Dialysis
Study will Evaluate 60 Participants with Results Expected in Q2 2024 LOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc.
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Study will Evaluate 60 Participants with Results Expected in Q2 2024\nLOS ALTOS, Calif., Dec. 18, 2023 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease (the “Company or “Unicycive”), today announced the enrollment of the first patient in its open-label, single-arm, multicenter, multidose pivotal clinical trial with Oxylanthanum Carbonate (OLC). OLC is a next-generation lanthanum-based phosphate binding agent utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. “The initiation of patient enrollment in our OLC pivotal clinical trial is a critical milestone as we strive to reduce the pill burden and improve quality of life for individuals with chronic kidney disease on dialysis,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “OLC’s novel characteristics have the potential to make it the best-in-class phosphate binder in the billion-dollar hyperphosphatemia market. Data from this pivotal trial is the last major component to complete our data package to file a New Drug Application (NDA) and will be informative for physicians as they consider a new potential therapy for their patients. We expect to report data from the trial in the second quarter of 2024 and file the NDA shortly thereafter.” The primary endpoint for the study will evaluate the tolerability of clinically effective doses of OLC in patients with CKD on dialysis. The secondary endpoints will evaluate safety and pharmacokinetics. There is no statistical analysis required to demonstrate efficacy as bioequivalence to Fosrenol® was previously established; and there is no other clinical study required to submit an NDA under the 505(b)(2) regulatory pathway. The trial is expected to enroll 60 evaluable participants. Once participants are enrolled into the trial, they will go through a washout period for two weeks to clear their current phosphate binder from their system. Participants will initially be dosed at 500 mg of OLC three times a day (TID) and be titrated to a clinically effective dose that is defined as the dose required to achieve a serum phosphate range of ≤5.5 mg/dL. The maximum dose of OLC tested will be 3000 mg/day (1000 mg TID). As a ...