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Unicycive Therapeutics Completes Enrollment in Pivotal Clinical Trial for Oxylanthanum Carbonate (OLC)
Topline Data Expected in Q2, 2024 LOS ALTOS, Calif., March 07, 2024 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage
About this update from Unicycive Therapeutics, Inc.
[{"type":"text","content":"Topline Data Expected in Q2, 2024\nLOS ALTOS, Calif., March 07, 2024 (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 enrollment has been completed in the 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 to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. “The completion of enrollment in our pivotal OLC clinical trial is a critical achievement for Unicycive as we strive to bring an improved therapy to chronic kidney disease patients struggling with hyperphosphatemia,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Positive results from the trial will provide the basis to file a New Drug Application (NDA) with the U.S. Food and Drug Administration (FDA). We remain on track with topline data expected from the trial towards the latter part of the second quarter of this year and plan to file the NDA shortly thereafter. We want to thank the clinical trial participants, investigators, and sites whose significant interest in OLC drove strong recruitment as we pursue the goal of improving treatment options in hyperphosphatemia.” “In this pivotal trial, we are looking to evaluate the tolerability, safety and pharmacokinetics of clinically effective doses of OLC in patients with CKD on dialysis. We believe the novel characteristics of OLC show its potential to be a best-in-class product to treat hyperphosphatemia by reducing the pill burden volume by more than 4-fold compared to the most prescribed phosphate binder. If approved, OLC will target the multibillion-dollar hyperphosphatemia market and will be a new potential therapy for physicians to administer to their patients,” added Dr. Gupta. About the Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial The trial is expected to have 60 evaluable patients. 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...