Main data expected by the end of the year 2022
On Track to File NDA in 2023
LOS ALTOS, Calif., Nov. 10, 2022 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, announced today that it has completed enrollment of subjects in the RENAZORB bioequivalence study (BE). RENAZORB (lanthanum dioxycarbonate) is an investigational phosphate-binding agent using proprietary nanoparticle technology that is being developed to treat hyperphosphatemia in CKD patients on dialysis.
The study is a randomized, open-label, two-way crossover BE study to establish pharmacodynamic bioequivalence between RENAZORB (lanthanum dioxycarbonate) and Fosrenol.® (lanthanum carbonate): the reference drug (RLD). Unicycive previously received confirmatory guidance from the US Food and Drug Administration (FDA) that this single study of BE in healthy volunteers would be eligible and that no other clinical studies are required for submission of an Application for Application. New Drug (NDA) through the 505(b) (2) pathway.
The study enrolled 40 subjects per treatment arm (a total of 80 subjects enrolled) for 64 evaluable subjects. The study design, including dose, primary endpoint, and sample size, was reviewed and aligned with the FDA prior to study initiation. The primary endpoint of the study is the LS (least squares) mean change in urinary phosphate excretion from baseline to the evaluation period.
“The completion of enrollment for this pivotal clinical study is an important milestone for Unicycive, and we look forward to reporting key data from this study by the end of this year,” said Shalabh Gupta, MD, CEO of Unicycive. Based on the results of our pivotal BE study, Unicycive will seek a pre-NDA meeting with the FDA later to file the NDA in 2023. We remain confident that an advanced phosphate binder with the unique product profile of RENAZORB will be a welcome option for patients with hyperphosphatemia and represents a significant global market opportunity for Unicycive.”
About RENAZORB (lanthanum dioxycarbonate)
RENAZORB is an investigational next-generation lanthanum-based phosphate binding agent using proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients on dialysis. Its potential best-in-class profile may have significant patient adherence benefits over currently available treatment options, as it requires fewer pills per dose and is swallowed rather than chewed.
Hyperphosphatemia is a serious medical condition that occurs in almost all patients with end-stage renal disease (ESKD). 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 the arteries and atherosclerosis (due to deposition of excess calcium-phosphorus complexes in soft tissues). Importantly, hyperphosphatemia is independently associated with increased mortality in patients with chronic kidney disease on dialysis. Based on clinical data available to date, more than 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.
Dialysis patients are already at increased risk of cardiovascular disease (due to underlying diseases such as diabetes and hypertension), and hyperphosphatemia further exacerbates this. Treatment of hyperphosphatemia aims to reduce serum phosphate levels through two means: (1) restrict dietary phosphorus intake; and (2) daily, and with every meal, use of oral phosphate-binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.
About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company that develops new treatments for kidney diseases. Unicycive’s lead drug, RENAZORB, is a new phosphate-binding agent in development for the treatment of hyperphosphatemia. UNI-494 is a patent-protected new drug candidate in late preclinical development for the treatment of acute kidney injury. For more information please visit unicive.com.
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements can be identified by using words such as “anticipate”, “believe”, “forecast”, “estimate” and “intend”. or other similar terms or expressions that refer to 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 various factors that could cause actual events to differ materially from those indicated in 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 the results of previous studies and trials may not predict the results of future trials Our clinical trials may be suspended or interrupted due to side effects. Unexpected risks or other security risks that could prevent approval of our product candidates; risks related to business interruptions, including the COVID-19 coronavirus outbreak, which could seriously damage our financial condition and increase our costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependency on 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 several important factors, including: uncertainties related to market conditions and other factors described in more detail in the section entitled “Risk Factors” in the Report Unicycive Annual Report on Form 10-K for the year ended December 31, 2021 and other periodic reports filed with the Securities and Exchange Commission. All 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.
ana marie fields
Stern Investor Relations
SOURCE: Unicycle Therapeutics, Inc.