Unicycive to Highlight Patient Reported Outcomes Data at Upcoming Medical Meetings Showing Oxylanthanum Carbonate Reduced Pill Burden and Improved Adherence in Treatment of Hyperphosphatemia
Unicycive Therapeutics (UNCY) announced the presentation of patient reported outcomes data from its pivotal UNI-OLC-201 clinical study of oxylanthanum carbonate (OLC) for treating hyperphosphatemia in chronic kidney disease patients on dialysis. The data will be presented at three major medical meetings in 2025: the Annual Dialysis Conference (March 13-16), National Kidney Foundation Spring Clinical Meetings (April 10-13), and American Nephrology Nurses Association National Symposium (May 1-4).
The company's OLC, utilizing proprietary nanoparticle technology, aims to reduce pill size and quantity for patients. The FDA has accepted OLC's New Drug Application with a PDUFA Target Action Date of June 28, 2025. Currently, hyperphosphatemia remains uncontrolled in 75% of U.S. dialysis patients due to issues with existing treatments.
The presentations will highlight how OLC reduces pill burden by half and improves treatment adherence, potentially offering a more effective solution for phosphate control in dialysis patients.
Unicycive Therapeutics (UNCY) ha annunciato la presentazione dei dati sugli esiti riportati dai pazienti del suo studio clinico fondamentale UNI-OLC-201 riguardante l'ossilanthanum carbonato (OLC) per il trattamento dell'iperfosfatemia nei pazienti con malattia renale cronica in dialisi. I dati saranno presentati in tre importanti congressi medici nel 2025: la Conferenza Annuale sulla Dialisi (13-16 marzo), le Riunioni Cliniche Primaverili della National Kidney Foundation (10-13 aprile) e il Simposio Nazionale dell'American Nephrology Nurses Association (1-4 maggio).
Il OLC dell'azienda, che utilizza una tecnologia proprietaria a base di nanoparticelle, mira a ridurre la dimensione e la quantità delle pillole per i pazienti. La FDA ha accettato la Domanda di Nuovo Farmaco per OLC con una Data di Azione Target PDUFA del 28 giugno 2025. Attualmente, l'iperfosfatemia rimane incontrollata nel 75% dei pazienti in dialisi negli Stati Uniti a causa di problemi con i trattamenti esistenti.
Le presentazioni evidenzieranno come OLC riduce il carico di pillole della metà e migliora l'aderenza al trattamento, offrendo potenzialmente una soluzione più efficace per il controllo del fosfato nei pazienti in dialisi.
Unicycive Therapeutics (UNCY) anunció la presentación de datos sobre los resultados informados por los pacientes de su estudio clínico pivotal UNI-OLC-201 sobre carbonato de oxilanthanum (OLC) para tratar la hiperfosfatemia en pacientes con enfermedad renal crónica en diálisis. Los datos se presentarán en tres importantes reuniones médicas en 2025: la Conferencia Anual de Diálisis (del 13 al 16 de marzo), las Reuniones Clínicas de Primavera de la Fundación Nacional del Riñón (del 10 al 13 de abril) y el Simposio Nacional de la Asociación Americana de Enfermeras en Nefrología (del 1 al 4 de mayo).
El OLC de la compañía, que utiliza tecnología de nanopartículas patentada, tiene como objetivo reducir el tamaño y la cantidad de pastillas para los pacientes. La FDA ha aceptado la Solicitud de Nuevo Medicamento de OLC con una Fecha Límite de Acción PDUFA del 28 de junio de 2025. Actualmente, la hiperfosfatemia sigue sin control en el 75% de los pacientes en diálisis en EE. UU. debido a problemas con los tratamientos existentes.
Las presentaciones destacarán cómo OLC reduce la carga de pastillas a la mitad y mejora la adherencia al tratamiento, ofreciendo potencialmente una solución más efectiva para el control del fosfato en pacientes en diálisis.
Unicycive Therapeutics (UNCY)는 옥실란타넘 탄산염 (OLC)의 임상 시험인 UNI-OLC-201에서 환자가 보고한 결과 데이터를 발표한다고 발표했습니다. 이는 투석 중인 만성 신장 질환 환자의 고인산혈증 치료를 위한 것입니다. 데이터는 2025년 세 가지 주요 의학 회의에서 발표될 예정입니다: 연례 투석 회의(3월 13-16일), 미국 신장 재단 봄 임상 회의(4월 10-13일), 미국 신장 간호사 협회 전국 심포지엄(5월 1-4일).
회사의 OLC는 독점 나노 입자 기술을 활용하여 환자들의 약물 크기와 수량을 줄이는 것을 목표로 하고 있습니다. FDA는 OLC의 신약 신청을 수락했으며, PDUFA 목표 행동 날짜는 2025년 6월 28일입니다. 현재 고인산혈증은 기존 치료의 문제로 인해 미국 투석 환자의 75%에서 조절되지 않고 있습니다.
발표에서는 OLC가 약물 부담을 절반으로 줄이고 치료 순응도를 개선하여 투석 환자의 인산염 조절을 위한 보다 효과적인 솔루션을 제공할 수 있는 방법을 강조할 것입니다.
Unicycive Therapeutics (UNCY) a annoncé la présentation de données sur les résultats rapportés par les patients de son étude clinique pivot UNI-OLC-201 concernant le carbonate d'oxilanthanum (OLC) pour traiter l'hyperphosphatémie chez les patients atteints de maladie rénale chronique sous dialyse. Les données seront présentées lors de trois grandes réunions médicales en 2025 : la Conférence Annuelle de Dialyse (du 13 au 16 mars), les Réunions Cliniques de Printemps de la National Kidney Foundation (du 10 au 13 avril) et le Symposium National de l'American Nephrology Nurses Association (du 1er au 4 mai).
Le OLC de l'entreprise, utilisant une technologie de nanoparticules propriétaire, vise à réduire la taille et la quantité de pilules pour les patients. La FDA a accepté la Demande de Nouveau Médicament pour OLC avec une Date Limite d'Action PDUFA fixée au 28 juin 2025. Actuellement, l'hyperphosphatémie reste incontrôlée chez 75 % des patients sous dialyse aux États-Unis en raison de problèmes avec les traitements existants.
Les présentations mettront en avant comment OLC réduit de moitié la charge médicamenteuse et améliore l'adhérence au traitement, offrant potentiellement une solution plus efficace pour le contrôle des phosphates chez les patients sous dialyse.
Unicycive Therapeutics (UNCY) hat die Präsentation von Patientenergebnissen aus seiner entscheidenden klinischen Studie UNI-OLC-201 zu Oxilanthanumcarbonat (OLC) zur Behandlung von Hyperphosphatämie bei Dialysepatienten mit chronischer Nierenerkrankung angekündigt. Die Daten werden auf drei wichtigen medizinischen Tagungen im Jahr 2025 präsentiert: der Jahrestagung zur Dialyse (13.-16. März), den Frühlingsklinischen Tagungen der National Kidney Foundation (10.-13. April) und dem Nationalen Symposium der American Nephrology Nurses Association (1.-4. Mai).
Das OLC des Unternehmens, das proprietäre Nanopartikeltechnologie nutzt, zielt darauf ab, die Pillengröße und -anzahl für die Patienten zu reduzieren. Die FDA hat den Antrag auf ein neues Medikament für OLC angenommen, mit einem PDUFA-Zieltermin am 28. Juni 2025. Derzeit bleibt die Hyperphosphatämie bei 75 % der Dialysepatienten in den USA aufgrund von Problemen mit bestehenden Behandlungen unkontrolliert.
Die Präsentationen werden hervorheben, wie OLC die Pillenlast um die Hälfte reduziert und die Therapietreue verbessert, was möglicherweise eine effektivere Lösung zur Phosphatkontrolle bei Dialysepatienten bietet.
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LOS ALTOS, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that it will present patient reported outcomes data from its pivotal UNI-OLC-201 clinical study characterizing the potential impact of oxylanthanum carbonate (OLC) on the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. These data will be presented at three medical meetings, including the 2025 Annual Dialysis Conference (ADC), March 13-16, 2025, National Kidney Foundation (NKF) Spring Clinical Meetings, April 10-13, 2025, and the 2025 American Nephrology Nurses Association (ANNA) National Symposium, being held on May 1-4, 2025.
Unicycive’s investigational drug OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. If approved, OLC may provide patients and their physicians with a welcome new option to control hyperphosphatemia. The New Drug Application (NDA) for OLC was accepted by the U.S. Food and Drug Administration (FDA) for the treatment of hyperphosphatemia in patients with chronic kidney disease on dialysis. The FDA set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
“Despite the availability of several approved phosphate binders, hyperphosphatemia remains uncontrolled in
Unicycive abstracts to be presented at the upcoming medical meetings include:
ADC
- Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: A-6870
- Presentation Details: Friday, March 14, 5:30-7:30 p.m. PT
- Presenting Author: Doug Jermasek
NKF Spring Clinical Meetings
- Title: Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence – Poster #: G-018
- Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
- Presenting Author: Guru Reddy, PhD
- Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients – Poster #: G-297
- Presentation Details: Thursday, April 10, from 5:15-7:30 p.m. ET
- Presenting Author: Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities
ANNA
- Title: Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients
- Presentation Details: Friday, May 2, starting at 8:45 a.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). 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 The global market opportunity for treating hyperphosphatemia is projected to be in excess of
Unicycive is seeking FDA approval of OLC via 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 patients on dialysis), multiple preclinical studies, and the chemistry, manufacturing and controls (CMC) data. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.
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
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.
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. Positive pivotal trial results were reported in June 2024 for OLC, and a New Drug Application (NDA) is under review by the U.S. Food and Drug Administration (FDA) with a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025. OLC is protected by a strong global patent portfolio including an issued patent on composition of matter with exclusivity until 2031, and with the potential patent term extension until 2035 after OLC approval. Unicycive’s second asset, UNI-494, is a patent-protected new chemical entity in clinical development for the treatment of conditions related to acute kidney injury. UNI-494 has successfully completed a Phase 1 trial. 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 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, 2023, 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.
1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business Insights™, Hyperphosphatemia Treatment Market, 2023-2030
3 US-DOPPS Practice Monitor, May 2021; http://www.dopps.org/DPM
4 Block GA, Klassen PS, Lazarus JM, Ofsthun N, Lowrie EG, Chertow GM. Mineral metabolism, mortality, and morbidity in maintenance hemodialysis. J Am Soc Nephrol. 2004 Aug;15(8):2208-18. doi: 10.1097/01.ASN.0000133041.27682.A2. PMID: 15284307.
Investor Contacts:
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LifeSci Advisors
kgardner@lifesciadvisors.com
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Rachel Visi
Real Chemistry
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FAQ
When is the FDA decision date for Unicycive's (UNCY) oxylanthanum carbonate?
What percentage of US dialysis patients currently have uncontrolled hyperphosphatemia?
How does UNCY's oxylanthanum carbonate improve patient treatment adherence?
At which medical conferences will Unicycive present its OLC data in 2025?
What are the main challenges with current hyperphosphatemia treatments that UNCY's OLC addresses?
