Unicycive Therapeutics Announces US FDA Approval

– FDA sets PDUFA action date of June 28, 2025

– Company prepares for commercial launch in 2025 –

LOS ALTOS, Calif., Nov. 11, 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 the U.S. Food and Drug Administration (FDA) has accepted the New Drug Application (NDA) for oxylanthanum carbonate (OLC). and has set a target date for implementation of the Prescription Drug User Fee Act (PDUFA) of June 28, 2025. If approved, OLC has the potential to significantly reduce the treatment burden for dialysis patients with hyperphosphatemia and chronic kidney disease (CKD).

“We are pleased with the FDA’s acceptance of our first NDA, a significant milestone in our efforts to bring this important treatment option to patients with kidney disease if approved,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “Dialysis patients with chronic kidney disease and hyperphosphatemia are often faced with a burdensome treatment schedule that involves taking up to 12 tablets per day. OLC may provide significant benefits in patient adherence compared to currently available treatment options because it requires a lower pill burden on patients in terms of number and size of pills per dose and the pills are swallowed rather than chewed for convenience. As our NDA is currently under review, we are preparing to commercialize and launch OLC in the second half of 2025, if approved.”

Unicycive is pursuing FDA approval of OLC through the 505(b)(2) regulatory pathway. The NDA submission package is based on data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD dialysis patients), several preclinical studies, and chemistry and manufacturing and control data (CMC ). OLC is protected by a strong global patent portfolio, including issued substance composition patents with exclusivity until 2031 and the possibility of patent extension until 2035.

As previously announced, FDA granted a waiver of PDUFA fees for the NDA application, representing a significant savings to Unicycive of approximately $4 million.

About Oxylanthanthane Carbonate (OLC)

Oxylanthan carbonate is a next-generation lanthanum-based phosphate binder utilizing proprietary nanoparticle technology being developed for the treatment of hyperphosphatemia in chronic kidney disease (CKD) patients requiring dialysis. OLC has over thirty issued and issued patents worldwide. Its potentially best-in-class profile could provide significant benefits in patient adherence compared to currently available treatment options, as it requires a lower pill burden for patients in terms of the number and size of pills per dose, which are swallowed rather than chewed. Based on a survey conducted in 2022, nephrologists stated that the largest unmet need in treating hyperphosphatemia with phosphate binders was reduced pill burden and better patient compliance.¹ The global market potential for the treatment of hyperphosphatemia is expected to exceed $2.5 billion, with more than $1 billion of this coming from the United States². Despite the availability of several FDA-approved medications, 75 percent of dialysis patients in the United States do not achieve target phosphate levels recommended in published medical guidelines.

¹Reason Research, LLC 2022 survey. Results here.
²Fortune Business Insights^TM, Hyperphosphatemia Treatment Market, 2021-2028

About hyperphosphatemia

Hyperphosphatemia is a serious condition that occurs in almost all patients with end-stage renal disease (ESRD). If left untreated, hyperphosphatemia leads to secondary hyperparathyroidism (SHPT), which then leads to 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 the deposition of excess calcium-phosphorus complexes in soft tissue). Importantly, hyperphosphatemia is independently associated with increased mortality in patients with chronic kidney disease requiring dialysis. Based on the clinical data available to date, over 80% of patients show signs of cardiovascular calcification when requiring dialysis.

Dialysis patients already have an increased risk of cardiovascular disease (due to underlying conditions such as diabetes and hypertension), and hyperphosphatemia further exacerbates this risk. Treatment of hyperphosphatemia aims to reduce serum phosphate levels in two ways: (1) restricting dietary phosphorus intake; and (2) daily intake of oral phosphate-binding drugs with each meal, which facilitate the fecal excretion of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

About Unicycive Therapeutics

Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney disease. Unicycive’s lead drug candidate, oxylanthanum carbonate (OLC), is a novel, investigational phosphate binder being developed for the treatment of hyperphosphatemia in dialysis patients with chronic kidney disease. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions associated with acute kidney injury. For more information, please visit Unicycive.com and follow us on LinkedIn, X 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 by words such as “anticipate,” “believe,” “project,” “estimate,” and “intend” or other similar expressions or expressions concerning Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results may differ materially could cause actual events to differ materially from those reflected in such forward-looking statements. These factors include, but are not limited to, that clinical trials involve a lengthy and expensive process with uncertain outcomes and the results of previous studies and trials may not be predictive of future trial results our clinical trials may be suspended or terminated 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; significant competition; uncertainties regarding patent protection and litigation; dependence on third parties; and risks associated with failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated in such forward-looking statements due to various important factors, including: uncertainties associated with market conditions and other factors, which are more fully described in the “Risk Factors” section of Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2023 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 of this press release and Unicycive expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.

FOR MORE INFORMATION PLEASE CONTACT:

Investors:

Kevin Gardner
LifeSci Advisor
[email protected]

Chris Calabrese
LifeSci Advisor
[email protected]

SOURCE: Unicycive Therapeutics, Inc.