New Data to be Presented on the Bioequivalence Study for OLC
LOS ALTOS, Calif., Feb. 14, 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 two posters related to the Company’s lead product candidate, oxylanthanum carbonate (OLC), will be presented at the National Kidney Foundation Spring Clinical Meeting taking place May 14-18, 2024, in Long Beach, California.
“We are proud to present two posters related to OLC at the National Kidney Foundation Spring Clinical Meeting, one of the premier medical conferences for the healthcare community focused on kidney disease,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Importantly, we will present new data from the bioequivalence study for OLC. We will also present results of a survey conducted to understand why patients may be non-compliant in taking the currently prescribed phosphate binders. We look forward to contributing meaningful results to this important event.”
Title:
Two-Way Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate
Lead Author:
Vandana Mathur, MD
Dates/Times:
Tuesday, May 14, 2024 from 3:00 p.m. – 5:00 p.m. PT
Wednesday, May 15, 2024 from 8:00 a.m. – 3.00 p.m. PT
Title:
Renal Dietitians Perceive Phosphate Binder and Low-Phosphate Diet Non-Compliance as Top Reasons for Above Target Serum Phosphorous Concentrations
Lead Author:
Kathleen Hill Gallant, PH.D.
Date/Time:
Tuesday, May 14, 2024 from 3:00 p.m. – 5:00 p.m. PT
Wednesday, May 15, 2024 from 8:00 a.m. – 3.00 p.m. PT
About Oxylanthanum Carbonate (OLC)
Oxylanthanum carbonate 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. OLC has over forty issued and granted patents globally. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden for patients in terms of number and size of pills per dose that are swallowed instead of chewed. Based on a survey conducted in 2022, Nephrologists stated that the greatest unmet need in the treatment of hyperphosphatemia with phosphate binders is a lower pill burden and better patient compliance.1
Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in more than 100 healthy subjects. The first study was a dose-ranging Phase 1 study to evaluate safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to evaluate pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was observed.
About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then results in renal osteodystrophy (a condition similar to osteoporosis and associated with significant bone disease, fractures and bone pain); cardiovascular disease with associated hardening of arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality for patients with chronic kidney disease on dialysis. Based on available clinical data to date, over 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.
Dialysis patients are already at an increased risk for cardiovascular disease (because of underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
Fosrenol® is a registered trademark of Shire International Licensing BV. 1Reason Research, LLC 2022 survey. Results here.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel investigational phosphate binding agent being developed for the treatment of hyperphosphatemia in chronic kidney disease patients on dialysis. UNI-494 is a patent-protected new chemical entity in late preclinical development for the treatment of acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as "anticipate," "believe," "forecast," "estimated" and "intend" or other similar terms or expressions that concern Unicycive's expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results could differ materially. There are several factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; risks related to business interruptions, which could seriously harm our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2022, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.
