UNCY - Unicycive Therapeutics Delivers Multiple Presentations on Oxylanthanum Carbonate (OLC) and UNI-494 at the European Renal Association Congress | Benzinga
– Results from Preclinical Model of Hyperphosphatemia Demonstrate the Relative Potency of OLC Compared to Tenapanor –
– Oral UNI-494 Shows Promise in a Preclinical Model as a Potential Candidate for Prevention of Delayed Graft Function Related to Acute Kidney Injury –
LOS ALTOS, Calif., May 28, 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 that several presentations were delivered on the Company's two product candidates, oxylanthanum carbonate (OLC) and UNI-494, at the 61st European Renal Association (ERA) Congress. 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). UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator initially targeting acute kidney injury (AKI).
"We were pleased to have such a meaningful presence at the ERA Congress with multiple oral and poster presentations on both OLC and UNI-494 demonstrating promising data in two forms of kidney disease," said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. "For OLC, we presented data showcasing the potent phosphate lowering capacity of OLC, which was three-fold greater than that of tenapanor in an established preclinical model of CKD. A second phase of this study, which we hope to present at a future scientific forum, will explore the potential complementary mechanisms of action of these two new phosphate lowering agents when administered in combination."
"We also presented valuable preclinical data of oral UNI-494 in a model of AKI that showed that a single oral dose of UNI-494 significantly reduced important markers related to kidney disease and that kidney functional data were well supported at both low and high doses. This data compliments our previously reported data in the intravenous (IV) form of UNI-494. The study concluded that UNI-494 is a potential candidate for prevention of delayed graft function (DGF) and other clinical conditions resulting from AKI. For both OLC and UNI-494, we also outlined our current clinical trials in progress and look forward to presenting those results this year," added Dr. Gupta.
Oxylanthanum Carbonate (OLC) Presentation Details:
Title: Enhanced Urinary Phosphorous Reduction: Comparative Study of Oxylanthanum Carbonate and Tenapanor in Rats
Lead Author: Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Results: This oral presentation evaluated the effects of tenapanor and OLC on phosphate excretion in rats. Tenapanor is a sodium hydrogen exchanger inhibitor used to reduce serum phosphate in adults with CKD on dialysis as an add-on therapy with phosphate binders. In this study, modeled after an earlier study with tenapanor and sevelamer, OLC demonstrated a significant reduction in urinary phosphate excretion compared to vehicle treated animals which was 3X greater than the reduction in urinary phosphate excretion observed with tenapanor which was not statistically different from vehicle. OLC and tenapanor utilize two different mechanisms of action to manage phosphate levels. Subsequent analyses will focus on examining the combination of tenapanor and OLC as the combination may lead to synergistic effects on lowering phosphate levels while providing patients with the benefit of reduced pill burden with OLC.
Title: Oxylanthanum Carbonate for Hyperphosphatemia in End Stage Kidney Disease (ESKD): Tolerability Trial in Progress
Lead Author: Pablo E. Pergola, M.D., Ph.D., Renal Associates, P.A.
Results: This poster describes a pivotal trial in progress to evaluate the tolerability of clinically effective (serum phosphate ?5.5 mg/dL) doses of OLC in patients on hemodialysis. OLC is a new lanthanum-based nanotechnology product in development with a high in vitro binding capacity as compared to other phosphate binders. OLC is formulated as a small pill that is swallowed whole instead of being chewed. This open-label, single-arm, multicenter, multidose study will enroll up to 90 patients on hemodialysis who require phosphate binder therapy and have mean historical serum phosphate levels between ?4.0 and ?7.0 mg/dL for ?8 weeks. Participants will undergo up to 3 weeks of ...