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Unicycive Therapeutics Announces Late-Breaker Poster Presentation on Oxylanthanum Carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024

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Unicycive Therapeutics (Nasdaq: UNCY) announced a late-breaker poster presentation on oxylanthanum carbonate (OLC) at the American Society of Nephrology (ASN) Kidney Week 2024. The presentation, titled 'Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia,' will be led by Dr. Geoffrey A. Block. Additionally, Unicycive will deliver three more poster presentations on OLC and UNI-494.

The conference will take place from October 24-27, 2024, in San Diego, CA. The additional presentations will cover topics such as the effects of intravenous UNI-494 on acute kidney injury, the combination of OLC and tenapanor in lowering urinary phosphate excretion, and the Phase I safety, tolerability, and pharmacokinetics of UNI-494. These presentations highlight Unicycive's ongoing research in kidney disease treatments.

Unicycive Therapeutics (Nasdaq: UNCY) ha annunciato una presentazione poster in sessione late-breaker su ossilanthanum carbonate (OLC) durante la American Society of Nephrology (ASN) Kidney Week 2024. La presentazione, intitolata 'Effetti dell'Ossilanthanum Carbonate nei Pazienti Sottoposti a Emodialisi di Mantenimento con Iperfosfatemia', sarà condotta dal Dott. Geoffrey A. Block. Inoltre, Unicycive presenterà altri tre poster su OLC e UNI-494.

La conferenza si svolgerà dal 24 al 27 ottobre 2024 a San Diego, CA. Le ulteriori presentazioni tratteranno argomenti come gli effetti dell'UNI-494 endovenoso sull'insufficienza renale acuta, la combinazione di OLC e tenapanor nella riduzione dell'escrezione urinaria di fosfato, e la sicurezza, tollerabilità e farmacocinetica della fase I di UNI-494. Queste presentazioni evidenziano la ricerca continua di Unicycive nei trattamenti per le malattie renali.

Unicycive Therapeutics (Nasdaq: UNCY) anunció una presentación de póster en sesión tardía sobre carbonato de oxilanthanum (OLC) en la American Society of Nephrology (ASN) Kidney Week 2024. La presentación, titulada 'Efectos del Carbonato de Oxilanthanum en Pacientes que Reciben Hemodiálisis de Mantenimiento con Hiperfosfatemia', estará a cargo del Dr. Geoffrey A. Block. Además, Unicycive realizará tres presentaciones más sobre OLC y UNI-494.

La conferencia se llevará a cabo del 24 al 27 de octubre de 2024 en San Diego, CA. Las presentaciones adicionales abordarán temas como los efectos de UNI-494 intravenoso en la lesión renal aguda, la combinación de OLC y tenapanor en la reducción de la excreción urinaria de fosfato, y la seguridad, tolerabilidad y farmacocinética de UNI-494 en la fase I. Estas presentaciones resaltan la investigación continua de Unicycive en tratamientos para enfermedades renales.

유니사이시브 테라퓨틱스(Nasdaq: UNCY)는 옥실란탄산염(OLC)에 대한 late-breaker 포스터 발표를 미국 신장학회(ASN) 신장 주간 2024에서 발표한다고 밝혔습니다. '고인산혈증을 가진 유지 혈액 투석 환자에서 옥실란탄산염의 효과'라는 제목의 발표는 Geoffrey A. Block 박사가 이끌 것입니다. 또한 유니사이시브는 OLC와 UNI-494에 관한 추가 포스터 발표를 3회 진행할 예정입니다.

이번 회의는 2024년 10월 24일부터 27일까지 미국 샌디에이고에서 열릴 예정입니다. 추가 발표에서는 급성 신손상에 대한 정맥 주입 UNI-494의 효과, OLC와 테나파노르의 조합을 통한 소변 내 인산염 배출 감소에 대한 내용, 그리고 UNI-494의 1상 안전성, 내약성 및 약동학에 대한 내용이 포함될 것입니다. 이러한 발표는 신장 질환 치료를 위한 유니사이시브의 지속적인 연구를 강조합니다.

Unicycive Therapeutics (Nasdaq: UNCY) a annoncé une présentation de poster en session tardive sur carbonate d'oxilanthanum (OLC) lors de la American Society of Nephrology (ASN) Kidney Week 2024. La présentation, intitulée 'Effets du carbonate d'oxilanthanum chez des patients recevant une hémodialyse de maintien avec hyperphosphatémie', sera dirigée par le Dr Geoffrey A. Block. De plus, Unicycive effectuera trois autres présentations de poster sur OLC et UNI-494.

La conférence aura lieu du 24 au 27 octobre 2024 à San Diego, CA. Les présentations supplémentaires couvriront des sujets tels que les effets de l'UNI-494 intraveineux sur les lésions rénales aiguës, la combinaison d'OLC et de ténafanor pour réduire l'excrétion urinaire de phosphate, ainsi que la sécurité, la tolérabilité et la pharmacocinétique de l'UNI-494 en phase I. Ces présentations mettent en évidence les recherches continues d'Unicycive dans les traitements des maladies rénales.

Unicycive Therapeutics (Nasdaq: UNCY) hat eine späte Posterpräsentation über Oxilanthanumcarbonat (OLC) auf der American Society of Nephrology (ASN) Kidney Week 2024 angekündigt. Die Präsentation mit dem Titel 'Effekte von Oxilanthanumcarbonat bei Patienten, die eine Erhaltungs-Hämodialyse mit Hyperphosphatämie erhalten', wird von Dr. Geoffrey A. Block geleitet. Zudem wird Unicycive drei weitere Posterpräsentationen zu OLC und UNI-494 halten.

Die Konferenz findet vom 24. bis 27. Oktober 2024 in San Diego, CA, statt. Die zusätzlichen Präsentationen werden Themen wie die Effekte von intravenösem UNI-494 auf akute Nierenschädigung, die Kombination von OLC und Tenapanor zur Senkung der renalen Phosphatausscheidung und die Phase-I-Sicherheit, Verträglichkeit und Pharmakokinetik von UNI-494 abdecken. Diese Präsentationen unterstreichen die laufende Forschung von Unicycive zur Behandlung von Nierenerkrankungen.

Positive
  • Unicycive's research on OLC and UNI-494 selected for presentation at a major nephrology conference
  • Late-breaker poster presentation indicates potentially significant findings for OLC in hemodialysis patients
  • Multiple presentations showcase Unicycive's diverse research pipeline in kidney disease treatments
Negative
  • None.

LOS ALTOS, Calif., Oct. 14, 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 a poster presentation on oxylanthanum carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Unicycive will also deliver three additional poster presentations on OLC and UNI-494. The conference will take place October 24-27, 2024 in San Diego, CA.

Late Breaking Science Poster:

Title:
Effects of Oxylanthanum Carbonate in Patients Receiving Maintenance Hemodialysis with Hyperphosphatemia
Lead Author:Geoffrey A. Block, MD, FASN, Associate Chief Medical Officer & Senior Vice President, Clinical Research & Medical Affairs, U.S. Renal Care
Session Title:Late-Breaking Science Posters [LB-PO]
Poster Board:#TH-PO1188
Date/Time:Thursday, October 24, 2024 from 10:00 a.m. – 12:00 p.m. PT
  

Three additional poster presentations:

 

Title:
Intravenous UNI-494 Slows the Progression or Halts/Reverses Acute Kidney Injury When Administered After Ischemia/Reperfusion in Rats
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Session Title:AKI: Mechanisms
Poster Board:#FR-PO155
Date/Time:Friday, October 25, 2024 from 10:00 a.m. – 12:00 p.m. PT


Title:
Combination Oxylanthanum Carbonate and Tenapanor Lowers Urinary Phosphate Excretion in Rat
Lead Author:Satya Medicherla, Ph.D., Vice President, Preclinical Pharmacology, Unicycive
Session Title:CKD-MBD: Basic and Translational
Poster Board:#SA-PO243
Date/Time:Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.m. PT


Title:
UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics
Lead Author:Guru Reddy, PH.D., Vice President of Preclinical R&D, Unicycive
Session Title:AKI: Clinical, Outcomes, and Trials - Management
Poster Board:#SA-PO036
Date/Time:Saturday, October 26, 2024 from 10:00 a.m. – 12:00 p.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 $2.5 billion in 2023, with the United States accounting for more than $1 billion of that total. Despite the availability of several FDA-cleared medications, 75 percent of U.S. dialysis patients fail to achieve the target phosphorus levels recommended by published medical guidelines.

Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. As part of the clinical development program, two clinical studies were conducted in over 100 healthy volunteers. The first study was a dose-ranging Phase I study to determine safety and tolerability. The second study was a randomized, open-label, two-way crossover bioequivalence study to establish pharmacodynamic bioequivalence between OLC and Fosrenol. Based on the results of the bioequivalence study, pharmacodynamic (PD) bioequivalence of OLC to Fosrenol was established. A pivotal clinical trial was also conducted in CKD patients on hemodialysis that achieved the study objective and established favorable tolerability of OLC at clinically effective doses.

Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.

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 80% of patients show signs of cardiovascular calcification by the time they become dependent on dialysis.

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 UNI-494

UNI-494 is a novel nicotinamide ester derivative and a selective ATP-sensitive mitochondrial potassium channel activator. Mitochondrial dysfunction plays a critical role in the progression of acute kidney injury and chronic kidney disease. UNI-494 has a novel mechanism of action that restores mitochondrial function and may be beneficial for the treatment of several diseases including kidney disease. Unicycive has completed enrollment in the UNI-494 Phase 1 dose-ranging safety study in healthy volunteers in the United Kingdom, and expects to report results in the third quarter of 2024. UNI-494 is protected by issued patent(s) in the U.S. and Europe and a wide range of patent applications worldwide. UNI-494 has been granted orphan drug designation (ODD) by the U.S. Food and Drug Administration (FDA) for the prevention of Delayed Graft Function (DGF) in kidney transplant patients.

About Acute Kidney Injury

Acute kidney injury (AKI) is defined as a sudden loss of kidney function that is determined based on increased serum creatinine levels and decreased urine output and is limited to a duration of 7 days. The primary causes of AKI include sepsis, ischemia, hypoxia, and drug-induced nephrotoxicity. Delayed Graft Function is a type of acute kidney injury that occurs in the first week after kidney transplantation. AKI is estimated to occur in 20-200 per million population in the community, 7-18% of patients in the hospital, and approximately 50% of patients admitted to the intensive care unit. Importantly AKI is associated with morbidity and mortality; an estimated 2 million people die of AKI worldwide every year whereas survivors of AKI are at increased risk of chronic kidney disease and end stage renal disease.

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. UNI-494 is a patent-protected new chemical entity in clinical development for the treatment of conditions related to 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 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.

Investor Contact:

ir@unicycive.com
(650) 543-5470

SOURCE: Unicycive Therapeutics, Inc.


FAQ

What is the main topic of Unicycive Therapeutics' (UNCY) late-breaker presentation at ASN Kidney Week 2024?

The late-breaker presentation focuses on the effects of oxylanthanum carbonate (OLC) in patients receiving maintenance hemodialysis with hyperphosphatemia.

How many poster presentations will Unicycive Therapeutics (UNCY) deliver at ASN Kidney Week 2024?

Unicycive Therapeutics will deliver a total of four poster presentations at ASN Kidney Week 2024, including one late-breaker and three additional presentations on OLC and UNI-494.

When and where will the ASN Kidney Week 2024 conference take place?

The ASN Kidney Week 2024 conference will take place from October 24-27, 2024, in San Diego, CA.

What are the topics of Unicycive Therapeutics' (UNCY) additional poster presentations at ASN Kidney Week 2024?

The additional presentations cover the effects of intravenous UNI-494 on acute kidney injury, the combination of OLC and tenapanor in lowering urinary phosphate excretion, and the Phase I safety, tolerability, and pharmacokinetics of UNI-494.

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