Unicycive Presents New Patient-Level Data Underscoring Challenges Faced with Current Phosphate Binders and Highlighting the Potential of Oxylanthanum Carbonate to Address Barriers to Adherence for Patients with Hyperphosphatemia on Dialysis
Unicycive Therapeutics (NASDAQ: UNCY) presented new patient-level data for its investigational hyperphosphatemia treatment, oxylanthanum carbonate (OLC), at the NKF Spring Clinical Meetings in Boston. The FDA has set a PDUFA date of June 28, 2025, for OLC's New Drug Application.
Key findings from the Phase 2 trial showed that OLC reduced pill burden by 50%, with patients taking a median of three tablets daily compared to six with previous treatments. Patient satisfaction metrics were notably strong: 70% reported consistent adherence with OLC (vs 58% for prior treatments), 79% preferred OLC over previous medications, and 98% found it easy to take (vs 38% for prior treatments).
A separate NKF survey of 200 dialysis patients identified key barriers to phosphate binder adherence: forgetfulness (63%), excessive pill number (47%), and large pill size (47%). Other challenges included difficulties carrying pills (45%), gastrointestinal side effects (29%), and unpleasant taste (20%).
Unicycive Therapeutics (NASDAQ: UNCY) ha presentato nuovi dati a livello di paziente per il suo trattamento investigativo dell'iperfosfatemia, il carbonato di ossilantano (OLC), durante le Riunioni Cliniche Primaverili NKF a Boston. La FDA ha fissato una data PDUFA del 28 giugno 2025 per la domanda di nuovo farmaco di OLC.
I risultati chiave dello studio di Fase 2 hanno mostrato che OLC ha ridotto il carico di pillole del 50%, con i pazienti che assumevano una media di tre compresse al giorno rispetto a sei con i trattamenti precedenti. Le metriche di soddisfazione dei pazienti sono state notevolmente forti: il 70% ha riportato un'aderenza costante con OLC (rispetto al 58% per i trattamenti precedenti), il 79% ha preferito OLC rispetto ai farmaci precedenti e il 98% lo ha trovato facile da assumere (rispetto al 38% per i trattamenti precedenti).
Un sondaggio separato della NKF su 200 pazienti in dialisi ha identificato le principali barriere all'aderenza ai leganti del fosfato: dimenticanza (63%), numero eccessivo di pillole (47%) e grandezza delle pillole (47%). Altre sfide includevano difficoltà nel trasportare le pillole (45%), effetti collaterali gastrointestinali (29%) e sapore sgradevole (20%).
Unicycive Therapeutics (NASDAQ: UNCY) presentó nuevos datos a nivel de pacientes para su tratamiento investigacional de la hiperfosfatemia, el carbonato de oxilantano (OLC), en las Reuniones Clínicas de Primavera de la NKF en Boston. La FDA ha establecido una fecha PDUFA del 28 de junio de 2025 para la Solicitud de Nuevo Medicamento de OLC.
Los hallazgos clave del ensayo de Fase 2 mostraron que OLC redujo la carga de pastillas en un 50%, con los pacientes tomando una mediana de tres tabletas diarias en comparación con seis con tratamientos anteriores. Las métricas de satisfacción del paciente fueron notablemente fuertes: el 70% informó una adherencia consistente con OLC (frente al 58% para tratamientos anteriores), el 79% prefirió OLC sobre medicamentos previos y el 98% lo encontró fácil de tomar (frente al 38% para tratamientos anteriores).
Una encuesta separada de la NKF a 200 pacientes en diálisis identificó las principales barreras para la adherencia a los quelantes de fosfato: olvido (63%), número excesivo de pastillas (47%) y tamaño grande de las pastillas (47%). Otros desafíos incluyeron dificultades para transportar las pastillas (45%), efectos secundarios gastrointestinales (29%) y sabor desagradable (20%).
유니사이브 테라퓨틱스 (NASDAQ: UNCY)는 보스턴에서 열린 NKF 봄 임상 회의에서 조사 중인 고인산혈증 치료제인 옥실란탄 탄산염(OLC)의 새로운 환자 수준 데이터를 발표했습니다. FDA는 OLC의 신약 신청에 대해 2025년 6월 28일을 PDUFA 날짜로 설정했습니다.
2상 시험의 주요 결과는 OLC가 약물 부담을 50% 줄였다는 것을 보여주었으며, 환자들은 이전 치료법에서 하루 평균 6정 대신 하루 평균 3정을 복용했습니다. 환자 만족도 지표는 특히 강력했습니다: 70%가 OLC에 대해 일관된 복용을 보고했다 (이전 치료법의 58%에 비해), 79%는 이전 약물보다 OLC를 선호했으며, 98%는 복용이 쉽다고 느꼈습니다 (이전 치료법의 38%에 비해).
200명의 투석 환자를 대상으로 한 별도의 NKF 설문조사는 인산염 결합제 복용에 대한 주요 장벽을 확인했습니다: 잊어버림 (63%), 과도한 알약 수 (47%), 큰 알약 크기 (47%). 기타 도전 과제에는 알약 운반의 어려움 (45%), 위장 부작용 (29%), 불쾌한 맛 (20%)이 포함되었습니다.
Unicycive Therapeutics (NASDAQ: UNCY) a présenté de nouvelles données au niveau des patients pour son traitement expérimental de l'hyperphosphatémie, le carbonate d'oxylanthane (OLC), lors des réunions cliniques de printemps de la NKF à Boston. La FDA a fixé une date PDUFA au 28 juin 2025 pour la demande de nouveau médicament d'OLC.
Les résultats clés de l'essai de phase 2 ont montré que OLC a réduit la charge de comprimés de 50%, les patients prenant en moyenne trois comprimés par jour contre six avec les traitements précédents. Les indicateurs de satisfaction des patients étaient particulièrement forts : 70% ont signalé une adhérence constante avec OLC (contre 58% pour les traitements antérieurs), 79% ont préféré OLC aux médicaments précédents et 98% l'ont trouvé facile à prendre (contre 38% pour les traitements antérieurs).
Une enquête séparée de la NKF auprès de 200 patients sous dialyse a identifié les principales barrières à l'adhérence aux liants de phosphate : l'oubli (63%), le nombre excessif de comprimés (47%) et la taille des comprimés (47%). D'autres défis comprenaient des difficultés à transporter les comprimés (45%), des effets secondaires gastro-intestinaux (29%) et un goût désagréable (20%).
Unicycive Therapeutics (NASDAQ: UNCY) hat auf den NKF Frühjahrs-Kliniktagungen in Boston neue patientenbezogene Daten zu seiner experimentellen Behandlung der Hyperphosphatämie, dem Oxylanthan-Carbonat (OLC), vorgestellt. Die FDA hat ein PDUFA-Datum für den 28. Juni 2025 für den Antrag auf ein neues Medikament von OLC festgelegt.
Wichtige Ergebnisse der Phase-2-Studie zeigten, dass OLC die Pillenlast um 50% reduzierte, wobei die Patienten im Durchschnitt drei Tabletten pro Tag im Vergleich zu sechs bei vorherigen Behandlungen einnahmen. Die Zufriedenheitskennzahlen der Patienten waren bemerkenswert stark: 70% berichteten von einer konstanten Einhaltung mit OLC (im Vergleich zu 58% bei früheren Behandlungen), 79% bevorzugten OLC gegenüber früheren Medikamenten und 98% fanden es einfach zu nehmen (im Vergleich zu 38% bei früheren Behandlungen).
Eine separate NKF-Umfrage unter 200 Dialysepatienten identifizierte wichtige Barrieren für die Einhaltung von Phosphatbindemitteln: Vergesslichkeit (63%), übermäßige Pillenzahl (47%) und große Pillengröße (47%). Weitere Herausforderungen umfassten Schwierigkeiten beim Transport von Pillen (45%), gastrointestinalen Nebenwirkungen (29%) und unangenehmen Geschmack (20%).
- 50% reduction in daily pill burden (3 vs 6 tablets)
- High patient satisfaction with 98% reporting ease of use
- Improved medication adherence (70% vs 58%)
- Strong patient preference with 79% favoring OLC
- FDA PDUFA date set for June 28, 2025
- Product still pending FDA approval
- 63% of surveyed patients report forgetfulness as adherence barrier
Insights
Unicycive's latest data presentation represents a significant regulatory milestone with the FDA having accepted their New Drug Application (NDA) for oxylanthanum carbonate (OLC) and set a PDUFA date of June 28, 2025. This places the company just months away from a potential approval decision for their hyperphosphatemia treatment.
The patient-reported outcomes from their Phase 2 trial address precisely what matters in phosphate binder therapy – adherence and patient satisfaction. With current therapies hampered by up to two-thirds of patients not consistently adhering to treatment, OLC's demonstrated 50% reduction in pill burden (median 3 tablets versus 6) tackles a fundamental clinical challenge.
The preference data is particularly compelling: 79% of patients preferred OLC versus just 4% favoring their pre-trial medications. This overwhelming preference, combined with improved adherence metrics (70% versus 58%), suggests OLC could potentially disrupt the phosphate binder market if approved.
The NKF survey data strategically validates OLC's development rationale, confirming that excessive pill number (47%) and large pill size (47%) rank among the top barriers to adherence – precisely the issues OLC's nanoparticle technology aims to address. This alignment between identified patient needs and OLC's design strengthens its potential positioning in the marketplace.
– Patient-reported outcomes from Phase 2 trial of oxylanthanum carbonate (OLC) demonstrate high patient satisfaction with OLC compared to their prior phosphate lowering therapy –
– Findings from a patient survey conducted in partnership with the National Kidney Foundation (NKF) showed excessive number and large size of phosphate binder pills to be top barriers to consistent medication use –
– Results to be presented in poster sessions at the NKF Spring Clinical Meetings –
LOS ALTOS, Calif., April 10, 2025 (GLOBE NEWSWIRE) -- Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced new patient-reported outcomes data from its pivotal Phase 2 study of OLC as well as from a new survey conducted by the National Kidney Foundation (NKF) with sponsorship from Unicycive. OLC is an investigational treatment for hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The findings will be presented today in poster sessions at the NKF Spring Clinical Meetings taking place in Boston.
OLC leverages proprietary nanoparticle technology to reduce the number and size of pills that patients must take. The U.S. Food and Drug Administration (FDA) accepted the New Drug Application (NDA) for OLC for the treatment of hyperphosphatemia in patients with CKD on dialysis and set a Prescription Drug User Fee Act (PDUFA) Target Action Date of June 28, 2025.
“As many as two out of three of patients with end-stage kidney disease undergoing dialysis don’t consistently adhere to their phosphate binder treatment; common barriers are side effects, pill burden, and unpalatable formulations,” said Dr. Pablo Pergola, MD, PhD, Research Director, Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial. “These new patient-reported outcomes underscore the potential of OLC to enhance adherence, reduce treatment burden and improve patient satisfaction. OLC could be a welcome new phosphate binder choice for patients with hyperphosphatemia due to its favorable tolerability, small, easy-to-swallow size and low pill burden.”
Patient-Reported Outcomes Data
Patient-reported outcomes from the open-label Phase 2 UNI-OLC-201 clinical trial compared patients’ satisfaction with their pre-trial phosphate binders versus OLC at the end of the study based on responses to a questionnaire completed by 80 patients. This research will be presented by Guru Reddy, PhD., in the poster titled "Patient-Reported Outcomes in a Pivotal Clinical Study of Hyperphosphatemia: Oxylanthanum Carbonate Reduces Pill Burden by Half and Improves Adherence" (Poster # G-018) on Thursday, April 10, from 5:15–7:30 p.m. ET.
Results:
- OLC reduced pill burden by
50% – patients took a median of three tablets of OLC per day versus six tablets of phosphate binders prior to the trial. - OLC improved adherence –
70% of patients reported consistent adherence with OLC compared to58% who reported adherence to their pre-trial phosphate binders. - OLC was preferred –
79% of patients indicated a preference for OLC versus4% who preferred their pre-trial phosphate binder medications. - OLC improved patient satisfaction –
98% of patients agreed that OLC was easy to take versus38% who said that about their pre-trial phosphate binder medication, and89% reported they were satisfied with OLC treatment versus49% who were satisfied with pre-trial phosphate binders.
Patient Survey Results
In partnership with Unicycive, NKF conducted an online survey of patients undergoing dialysis to assess the top barriers to phosphate binder adherence and to better understand what treatment characteristics could improve adherence. A total of 200 patients aged 40 and older completed the online survey from February 15 to May 16, 2024. This research will be presented by Dr. Hill Gallant, PhD, RD, Associate Professor of Nutrition in the Department of Food Science and Nutrition at the University of Minnesota-Twin Cities, in a poster titled “Pill Burden and Large Tablet Size Are Key Barriers to Phosphate Binder Adherence in Dialysis Patients” (Poster # G-297) on Thursday, April 10, from 5:15-7:30 p.m. ET.
Results showed:
- Forgetfulness (
63% ) was the primary barrier to consistent medication use followed by excessive pill number (47% ) and large pill size (47% ). - Additional barriers to adherence included difficulties carrying pills (
45% ), gastrointestinal side effects (29% ), unpleasant taste (20% ), social embarrassment when taking medication (13% ), and cost (10% ). - Patients were more likely to prefer medication regimens with fewer and smaller pills, underscoring the impact of pill burden on adherence.
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, 2024, 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.
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FAQ
What are the key benefits of UNCY's oxylanthanum carbonate (OLC) compared to existing phosphate binders?
When is the FDA PDUFA date for UNCY's oxylanthanum carbonate?
What percentage of patients reported consistent adherence with UNCY's OLC in Phase 2 trials?
What are the main barriers to phosphate binder adherence according to UNCY's NKF survey?
