– OLC demonstrates bioequivalence with lanthanum carbonate –
– Additional poster highlighting the main features of OLC as seen by nephrology nutritionists –
Los Altos, Calif., May 15, 2024 (Globe Newswire) — Unicycive Therapeutics, Inc. (NASDAQ: UNCY) (the “Company”), a clinical-stage biotechnology company developing treatments for patients with kidney disease, (or “Unicycive”) today announced that two posters related to its lead product candidate, oxilanthanum carbonate (OLC), were presented at the National Kidney Foundation (NKF) Spring Clinical Meeting. OLC is a next-generation lanthanum-based phosphate binder utilizing proprietary nanoparticle technology that is being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients.
“The NKF Spring Clinical Meeting was an important meeting for Unicycive as we were able to present data from the OLC bioequivalence study and our second poster was featured as the highest rated submission.” said Dr. Shalabh Gupta, Chief Executive Officer. “Phosphate binders are essential in the management of hyperphosphatemia in CKD patients, but their effectiveness is adversely affected by noncompliance or restriction of phosphate binding capacity to dietary intake. Importantly, the data showed similar results in both groups in terms of mean change in urinary phosphate excretion, supporting that OLC is bioequivalent to lanthanum carbonate (LC). It demonstrated a well-tolerated safety profile with no serious adverse events. This data is a key component of the new drug application submitted to the FDA under the 505(b)(2) regulatory pathway. It is important because it functions as
Dr. Gupta concluded: “Dr. Hill Gallant, who presented a poster on a survey of renal dietitians who play a critical role in assisting patients with serum phosphate management and who witness first-hand their patients’ experiences and challenges in phosphate management. The findings conclude that strategies are needed to reduce pill burden and increase ease of use for patients, and, if approved, OLC features include reducing pill volume. This strengthens our belief that compliance can be improved and quality of life can be improved for patients living with this condition.”
Presentation details:
Title: Two-way crossover study to establish pharmacodynamic bioequivalence between oxilanthanum carbonate and lanthanum carbonate
Lead author: Vandana Mathur, MD
Results: A poster presentation described the results of a randomized crossover bioequivalence study comparing OLC and lanthanum carbonate (LC). This study was a phase 1, single-center study designed to demonstrate pharmacodynamic (PD) equivalence between two phosphate binders, i.e., comparing orally administered OLC and LC. , was a randomized 1:1, open-label, controlled, two-way crossover study. Both treatments were administered at a dose of one 1000 mcg tablet three times a day (TID) to healthy volunteers who consumed the same standardized diet to control daily phosphate intake. . OLC tablets are swallowed whole, as opposed to LC tablets, which must be chewed completely. The study consisted of a screening period, two treatment periods separated by a 14-day washout period, and a follow-up period 7 days after the last study drug dose. The primary PD variable was the least squares (LS) mean change in urinary phosphate excretion from baseline (48 hours before dosing) to the evaluation period (days 1-3). Baseline characteristics were balanced between OLC/LC and LC/OLC sequences. The LS mean change from baseline in OLC (-320.4 mg/day) was similar to the LS mean change from BL in LC (-324.0 mg/day). The 90% confidence interval for the LS mean change in urinary phosphate excretion from baseline (see test) was (-37.83, 45.12), within the predefined ±20% tolerance (-64.80, 64,80). was completely included. . There were no serious adverse events (SAEs) or treatment discontinuations. The incidence of treatment-emergent adverse events (TEAEs) and related AEs was also similar in both groups at 35% and 25%, respectively.
title: Renal nutritionists recognize nonadherence to phosphate binders and low-phosphate diets as the main reasons why serum phosphorus levels exceed target values
Lead author: Kathleen Hill Gallant, PhD, RD
Results: A poster presentation presents the results of a recent dietitian survey that assessed perceived reasons for nonadherence to phosphate binder (PB) therapy and identified the most attractive potential aspects of OLC. Masu. The authors conclude that strategies that reduce pill burden and increase patient ease of use may promote PB treatment compliance and improve patient outcomes. OLC is a small pill that can be swallowed whole without chewing, and has the potential to address compliance issues seen with current PB. In fact, 47% of dietitians said OLC was perceived to be more efficacious, and 34% said the lower number of pills required was perceived as the most appealing aspect of OLC.
Recent studies have reported PB nonadherence rates of up to 78% in patients with end-stage renal disease undergoing dialysis. For the analysis, 100 renal dietitians were surveyed and some key findings were obtained. The most common reasons for phosphate values above the target range were nonadherence to PB regimen (36%) or low phosphate diet (34%). There were two main reasons for discontinuing PB: too many tablets and problems with the formulation. One-third of dietitians believed that nonadherence, in which patients forget to take their PB with a meal or snack, was the cause, and 16% believed that it was due to a high medication burden. thinking about.
About oxilanthanum carbonate (OLC)
Oxilanthanum carbonate is a next-generation lanthanum-based phosphate binder utilizing proprietary nanoparticle technology that is being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients. OLC has issued and granted more than 40 patents worldwide. A potentially best-in-class profile should reduce patient pill burden in terms of the number and size of tablets per serving that are swallowed rather than chewed, thus improving patient adherence better than currently available treatment options. There can be significant benefits. Based on a survey conducted in 2022, nephrologists say the biggest unmet need in the treatment of hyperphosphatemia with phosphate binders is to reduce pill burden and improve patient compliance. I said that it is important to let people know.1 The global market opportunity for hyperphosphatemia treatment is expected to exceed $2.5 billion in 2023, with the United States accounting for more than $1 billion. Despite the availability of several FDA-approved drugs, 75% of dialysis patients in the United States do not achieve target phosphorus concentrations recommended by published medical guidelines.
Unicycive is seeking FDA approval for OLC through the 505(b)(2) regulatory pathway. As part of the clinical development program, two of his clinical studies were conducted on over 100 healthy volunteers. The first study was a phase I dose-ranging study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the topline results of bioequivalence studies, pharmacodynamic (PD) bioequivalence of OLC and Fosrenol was established.
Fosrenol® is a registered trademark of Shire International Licensing BV.
12022 Survey of Reason Research, LLC.result here.
About hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with end-stage renal disease (ESRD). Hyperphosphatemia, if left untreated, can lead to secondary hyperparathyroidism (SHPT), which then leads to renal osteodystrophy (a condition similar to osteoporosis, with significant bone disease, fractures, and bone pain). cause. Cardiovascular diseases with arteriosclerosis and atherosclerosis (due to the deposition of excessive calcium phosphorus complexes in soft tissues). Importantly, hyperphosphatemia is independently associated with increased mortality in chronic kidney disease patients undergoing dialysis. Based on the clinical data available to date, over 80% of patients show signs of cardiovascular calcification by the time they become dialysis dependent.
Dialysis patients are already at high risk for cardiovascular disease (due to underlying conditions such as diabetes and hypertension), and hyperphosphatemia exacerbates this. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels by two means: (1) Limit phosphorus intake from meals. (2) Use oral phosphate binders every day and with each meal to promote excretion of dietary phosphate through the feces rather than absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing new treatments for kidney diseases. Unicycive's lead drug candidate, oxilanthanum carbonate (OLC), is a novel investigational phosphate binder being developed for the treatment of hyperphosphatemia in chronic kidney disease patients undergoing dialysis. UNI-494 is a new patent-protected chemical entity in late-stage preclinical development for the treatment of acute kidney injury. Learn more about. Unicycive.com and follow us linkedin and YouTube.
Forward-looking statements
Certain statements in this press release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified by the use of words such as “expects,” “believes,” “anticipates,” “estimates,” “intends,” and similar words. ” or other similar terms or expressions regarding Unicycive's expectations, strategies, plans or intentions. These forward-looking statements are based on Unicycive's current expectations and actual results may differ materially. There are several factors that could cause actual events to differ materially from those indicated in such forward-looking statements. These factors include that clinical trials involve long and expensive processes, results are uncertain, and the results of previous studies and trials may not be predictive of future trial results. but not limited to. Our clinical trials may be paused or discontinued due to unanticipated side effects or other safety risks that could prevent the approval of our product candidates. risks related to business interruptions that could have a material adverse effect on our financial condition and increase our costs and expenses; Dependence on key figures. Substantive competition. Patent Protection and Litigation Uncertainty. Reliance on Third Parties. risks related to failure to obtain FDA clearance or approval and noncompliance with FDA regulations; Actual results may differ materially from those indicated in such forward-looking statements as a result of a variety of important factors, including: Uncertainties and other factors related to market conditions are further discussed in the “Risk Factors” section of Unicycive's annual report. 10-K for the year ended December 31, 2023, and other periodic reports filed with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date of this press release, and Unicycive does not warrant that the forward-looking statements contained in this press release, whether as a result of new information, future events or otherwise, We specifically disclaim any obligation to update the.
Investor contact information:
ir@unicycive.com
(650) 543-5470
Source: Unicycive Therapeutics, Inc.