Unicycive Therapeutics Announces the Publication of Patient Perspectives on Phosphate Management in the Journal of Nephrological Science
Unicycive Therapeutics (UNCY) announced the publication of a review on patient perspectives regarding phosphate management in the Journal of Nephrological Science. The study highlights significant challenges in phosphate management therapies, particularly focusing on phosphate binders used by chronic kidney disease (CKD) patients.
The research revealed that non-adherence rates to phosphate binders range from 22% to 74%, with a mean rate of 51%. Key barriers identified include large pill size, high pill burden (making up about 50% of daily pills), and palatability issues. The company positions its product, Oxylanthanum Carbonate (OLC), as a potential solution, highlighting its smaller pill size and lower pill burden.
The publication emphasizes the importance of understanding patient challenges in phosphorus management, as hyperphosphatemia is linked to increased mortality risk in dialysis patients. The findings suggest that new therapies reducing pill size and burden while maintaining efficacy could improve clinical outcomes and patient satisfaction.
Unicycive Therapeutics (UNCY) ha annunciato la pubblicazione di una revisione sulle prospettive dei pazienti riguardo alla gestione del fosfato nel Journal of Nephrological Science. Lo studio evidenzia sfide significative nelle terapie per la gestione del fosfato, concentrandosi in particolare sui leganti del fosfato utilizzati dai pazienti con malattia renale cronica (CKD).
La ricerca ha rivelato che i tassi di non aderenza ai leganti del fosfato variano dal 22% al 74%, con un tasso medio del 51%. I principali ostacoli identificati includono le grandi dimensioni delle pillole, l'alto carico di pillole (che rappresenta circa il 50% delle pillole giornaliere) e problemi di palatabilità. L'azienda posiziona il suo prodotto, Carbonato di Oxilanthanum (OLC), come una potenziale soluzione, evidenziando le sue dimensioni più piccole e un carico di pillole inferiore.
La pubblicazione sottolinea l'importanza di comprendere le sfide dei pazienti nella gestione del fosforo, poiché l'ipofosfatemia è collegata a un aumentato rischio di mortalità nei pazienti in dialisi. I risultati suggeriscono che nuove terapie che riducono le dimensioni delle pillole e il carico pur mantenendo l'efficacia potrebbero migliorare gli esiti clinici e la soddisfazione dei pazienti.
Unicycive Therapeutics (UNCY) anunció la publicación de una revisión sobre las perspectivas de los pacientes en relación con la gestión del fosfato en el Journal of Nephrological Science. El estudio destaca los desafíos significativos en las terapias de gestión del fosfato, centrándose especialmente en los unificantes de fosfato utilizados por los pacientes con enfermedad renal crónica (ERC).
La investigación reveló que las a los unificantes de fosfato oscilan entre el 22% y el 74%, con una tasa media del 51%. Los principales obstáculos identificados incluyen el gran tamaño de las píldoras, la alta carga de píldoras (que representa alrededor del 50% de las píldoras diarias) y los problemas de palatabilidad. La compañía posiciona su producto, Carbonato de Oxilanthanum (OLC), como una posible solución, destacando su tamaño más pequeño y una carga de píldoras menor.
La publicación enfatiza la importancia de comprender los desafíos de los pacientes en la gestión del fósforo, ya que la hiperfosfatémia está vinculada a un aumento del riesgo de mortalidad en pacientes en diálisis. Los hallazgos sugieren que las nuevas terapias que reducen el tamaño de las píldoras y la carga, manteniendo la eficacia, podrían mejorar los resultados clínicos y la satisfacción del paciente.
유니사이브 치료제 (UNCY)는 신장학 저널에 환자의 인산염 관리에 관한 관점에 대한 리뷰 논문을 발표했다고 발표했습니다. 연구는 만성 신장 질환 (CKD) 환자들이 사용하는 인산염 결합제에 중점을 두면서 인산염 관리 치료법에서의 중요한 도전 과제를 강조합니다.
연구 결과, 불일치율이 22%에서 74% 사이이며 평균율이 51%임을 나타냈습니다. 주요 장애물로는 큰 알약 크기, 높은 알약 부담 (일일 알약의 약 50% 차지) 및 맛 문제 등이 확인되었습니다. 이 회사는 옥실란타늄-carbonate (OLC)를 잠재적인 솔루션으로 포지셔닝하며, 더 작은 알약 크기와 낮은 알약 부담을 강조합니다.
이러한 출처는 환자의 인산염 관리에서의 도전을 이해하는 것이 중요하다고 강조하며, 고인산혈증은 투석 환자의 사망 위험 증가와 관련이 있습니다. 결과는 효능을 유지하면서 알약 크기와 부담을 줄이는 새로운 치료법이 임상 결과 및 환자 만족도를 향상시킬 수 있을 것이라고 제안합니다.
Unicycive Therapeutics (UNCY) a annoncé la publication d'une revue sur les perspectives des patients concernant la gestion des phosphates dans le Journal of Nephrological Science. L'étude met en lumière des défis significatifs liés aux thérapies de gestion des phosphates, en se concentrant particulièrement sur les agents liants utilisés par les patients atteints de maladie rénale chronique (MRC).
La recherche a révélé que les taux de non-adhérence aux agents liants phosphatés varient entre 22% et 74%, avec un taux moyen de 51%. Les principaux obstacles identifiés incluent la grande taille des comprimés, une charge en comprimés élevée (représentant environ 50% des comprimés quotidiens), et des problèmes de goût. La société positionne son produit, Carbonate d'Oxilanthanum (OLC), comme une solution potentielle, mettant en avant sa plus petite taille de comprimé et une charge de comprimé plus faible.
La publication souligne l'importance de comprendre les défis auxquels les patients sont confrontés dans la gestion du phosphore, car l'hyperphosphatémie est liée à un risque accru de mortalité chez les patients sous dialyse. Les résultats suggèrent que de nouvelles thérapies réduisant la taille et la charge des comprimés tout en maintenant l'efficacité pourraient améliorer les résultats cliniques et la satisfaction des patients.
Unicycive Therapeutics (UNCY) hat die Veröffentlichung einer Übersicht über die Patientenperspektiven bezüglich des Phosphatmanagements im Journal of Nephrological Science angekündigt. Die Studie hebt bedeutende Herausforderungen bei der Phosphatmanagement-Therapie hervor, wobei der Fokus insbesondere auf Phosphatbindemitteln liegt, die von Patienten mit chronischer Nierenkrankheit (CKD) verwendet werden.
Die Forschung hat ergeben, dass die Nichtbehandlungsraten für Phosphatbinder zwischen 22% und 74% liegen, mit einer durchschnittlichen Rate von 51%. Wichtige identifizierte Barrieren sind die große Pillengröße, die hohe Pillenbelastung (etwa 50% der täglichen Pillen) und Probleme mit der Geschmacksakzeptanz. Das Unternehmen positioniert sein Produkt, Oxilanthanum Carbonat (OLC), als potenzielle Lösung und hebt seine kleinere Pillengröße und geringere Pillenbelastung hervor.
Die Veröffentlichung betont die Bedeutung, die Herausforderungen der Patienten im Phosphormanagement zu verstehen, da Hyperphosphatämie mit einem erhöhten Sterblichkeitsrisiko bei Dialysepatienten verbunden ist. Die Ergebnisse deuten darauf hin, dass neue Therapien, die die Pillengröße und -belastung reduzieren und gleichzeitig die Wirksamkeit beibehalten, die klinischen Ergebnisse und die Patientenzufriedenheit verbessern könnten.
- OLC's characteristics (small pill size, lower burden) address key patient adherence challenges
- Company's product directly targets an identified medical need with high non-adherence rates
- None.
Insights
This publication strategically positions Unicycive's Oxylanthanum Carbonate (OLC) in the hyperphosphatemia treatment market by highlighting critical patient adherence challenges with current therapies. The reported 51% mean non-adherence rate to phosphate binders represents a substantial market opportunity, particularly considering hyperphosphatemia's direct link to mortality risk in CKD patients.
The market implications are significant. Current phosphate binders generate global sales exceeding
From a clinical perspective, improving adherence could significantly impact patient outcomes. With phosphate binders comprising approximately 50% of dialysis patients' daily pill burden, a more patient-friendly option could dramatically improve treatment compliance. This aligns with value-based care initiatives, as better phosphate control typically results in reduced hospitalizations and improved survival rates.
For investors, several key considerations emerge:
- OLC's potential as a differentiated product in a large, established market
- The clear unmet need validated by peer-reviewed research
- The alignment with healthcare's shift toward patient-centric solutions
- The potential for premium pricing based on improved compliance benefits
While this publication strengthens OLC's market positioning, successful commercialization will depend on upcoming regulatory decisions and the ability to demonstrate superior real-world outcomes. The timing of this publication suggests confidence in OLC's development progress and potential near-term catalysts.
Large pill size, high pill burden and palatability were identified as key barriers for phosphate binder adherence
LOS ALTOS, Calif., Jan. 28, 2025 (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 the publication of a review on patient perspectives regarding phosphate management in the peer-reviewed journal, Journal of Nephrological Science.
The publication, entitled “Patient Perspectives: The Effects of Contemporary Phosphorus Management on Quality of Life,” examines the challenges of phosphate management therapies from patients’ viewpoints, focusing on the limitations of current phosphate binders and their effect on patients’ quality of life. The publication underscores key findings from patient surveys and medical literature, identifying critical barriers to effective phosphorus management and emphasizing the need for patient-centered approaches to improve clinical outcomes and patient satisfaction.
“In therapeutic categories with significant patient non-adherence to standard of care like chronic kidney disease (CKD), it is essential to understand the factors disrupting medical intervention in order to offer physicians and patients innovative solutions,” said Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “We believe products like Oxylanthanum Carbonate (OLC), which is characterized by small pill size, lower pill burden, and easy-to-swallow tablets, have the potential to address many of the inherent challenges in phosphorus management that often lead to nonadherence and poor serum phosphate control. If approved, we look forward to offering OLC to CKD patients on dialysis with hyperphosphatemia.”
Key Findings:
- Hyperphosphatemia is linked to increased mortality risk.
- Dialysis patients often face a high daily pill burden, with phosphate binders making up about
50% of the total. - Nonadherence to phosphate binders is a significant challenge contributing to elevated phosphate levels. Studies show non-adherence rates range from
22% to74% , with a mean non-adherence rate of51% . - Factors contributing to non-adherence include large pill size, high pill burden, and unpleasant gastrointestinal side effects. Social factors and timing complexities also impact adherence.
- Engaging patients in discussions about different phosphate binders and their unique characteristics is key to improving adherence and satisfaction. New therapies that reduce pill size or burden while maintaining efficacy could enhance clinical outcomes, quality of life, and the patient-clinician relationship.
The full publication can be accessed here.
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:
Kevin Gardner
LifeSci Advisors
kgardner@lifesciadvisors.com
Chris Calabrese
LifeSci Advisors
ccalabrese@lifesciadvisors.com
SOURCE: Unicycive Therapeutics, Inc.
FAQ
What are the main challenges for phosphate binder adherence according to UNCY's published study?
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