Unicycive Therapeutics Announces Publication of Oxylanthanum Carbonate (OLC) Positive Bioequivalence Data in Clinical Therapeutics
Unicycive Therapeutics (UNCY) announced the publication of positive bioequivalence data for oxylanthanum carbonate (OLC) in Clinical Therapeutics journal. The study demonstrated pharmacodynamic bioequivalence between OLC and Fosrenol® (lanthanum carbonate) in treating hyperphosphatemia in kidney disease patients.
The randomized crossover study involved 80 participants, with 75 completing all doses. Results showed similar least squares mean change in urinary phosphate excretion: OLC (-320.4 mg/day) versus LC (-324.0 mg/day), with a between-group difference of 3.6 mg/day. Both treatments were well-tolerated with comparable adverse event profiles. The company's New Drug Application for OLC is under review, with commercial launch planned for 2025.
Unicycive Therapeutics (UNCY) ha annunciato la pubblicazione di dati positivi di bioequivalenza per il carbonato di ossilantanato (OLC) nella rivista Clinical Therapeutics. Lo studio ha dimostrato la bioequivalenza farmacodinamica tra OLC e Fosrenol® (carbonato di lantanio) nel trattamento dell'iperfosfatemia nei pazienti con malattia renale.
Lo studio randomizzato a crossover ha coinvolto 80 partecipanti, di cui 75 hanno completato tutti i dosaggi. I risultati hanno mostrato un cambiamento medio quadratico minimo simile nell'escrezione urinaria di fosfato: OLC (-320,4 mg/giorno) rispetto a LC (-324,0 mg/giorno), con una differenza tra i gruppi di 3,6 mg/giorno. Entrambi i trattamenti sono stati ben tollerati con profili di eventi avversi comparabili. La richiesta di nuovo farmaco della compagnia per OLC è in fase di revisione, con il lancio commerciale previsto per il 2025.
Unicycive Therapeutics (UNCY) anunció la publicación de datos positivos de bioequivalencia para el carbonato de oxilantanato (OLC) en la revista Clinical Therapeutics. El estudio demostró la bioequivalencia farmacodinámica entre OLC y Fosrenol® (carbonato de lantano) en el tratamiento de la hiperfosfatemia en pacientes con enfermedad renal.
El estudio cruzado aleatorio involucró a 80 participantes, de los cuales 75 completaron todas las dosis. Los resultados mostraron un cambio cuadrático mínimo medio similar en la excreción urinaria de fosfato: OLC (-320,4 mg/día) frente a LC (-324,0 mg/día), con una diferencia entre grupos de 3,6 mg/día. Ambos tratamientos fueron bien tolerados con perfiles de eventos adversos comparables. La solicitud de nuevo medicamento de la compañía para OLC está en revisión, con un lanzamiento comercial planificado para 2025.
유니사이브 테라퓨틱스 (UNCY)는 Clinical Therapeutics 저널에 옥실란타늄 탄산염(OLC)의 긍정적인 생물학적 동등성 데이터 발표를 알렸습니다. 본 연구는 신장 질환 환자의 고인산혈증 치료에 있어 OLC와 Fosrenol® (란타늄 탄산염) 간의 약리학적 생물학적 동등성을 입증했습니다.
무작위 교차 연구에는 80명의 참가자가 포함되었으며, 이 중 75명이 모든 용량을 완료했습니다. 결과는 요중 인산염 배설량의 최소제곱평균 변화가 OLC(-320.4 mg/일)와 LC(-324.0 mg/일) 간에 유사하다는 것을 보여주었으며, 그룹 간 차이는 3.6 mg/일이었습니다. 두 치료법 모두 잘 견딜 수 있었으며, 부작용 프로필도 비슷했습니다. 회사의 OLC 새로운 약물 신청은 심사 중이며, 상업적 출시가 2025년으로 계획되어 있습니다.
Unicycive Therapeutics (UNCY) a annoncé la publication de données positives de bioéquivalence pour le carbonate d'oxylanthane (OLC) dans la revue Clinical Therapeutics. L'étude a démontré la bioéquivalence pharmacodynamique entre l'OLC et le Fosrenol® (carbonate de lanthane) dans le traitement de l'hyperphosphatémie chez les patients atteints de maladies rénales.
L'étude croisée randomisée a impliqué 80 participants, dont 75 ont terminé toutes les doses. Les résultats ont montré un changement moyen des carrés minimaux similaire dans l'excrétion urinaire de phosphate : OLC (-320,4 mg/jour) contre LC (-324,0 mg/jour), avec une différence entre les groupes de 3,6 mg/jour. Les deux traitements ont été bien tolérés avec des profils d'événements indésirables comparables. La demande de nouveau médicament de la société pour l'OLC est en cours d'examen, avec un lancement commercial prévu pour 2025.
Unicycive Therapeutics (UNCY) gab die Veröffentlichung positiver Bioäquivalenzdaten für Oxylanthanumcarbonat (OLC) in der Zeitschrift Clinical Therapeutics bekannt. Die Studie zeigte die pharmacodynamische Bioäquivalenz zwischen OLC und Fosrenol® (Lanthanumcarbonat) bei der Behandlung von Hyperphosphatämie bei Nierenkrankheitspatienten.
Die randomisierte Cross-Over-Studie umfasste 80 Teilnehmer, von denen 75 alle Dosierungen abgeschlossen haben. Die Ergebnisse zeigten eine ähnliche minimale quadratische Mitteländerung der Harnphosphatausscheidung: OLC (-320,4 mg/Tag) im Vergleich zu LC (-324,0 mg/Tag), mit einem Unterschied zwischen den Gruppen von 3,6 mg/Tag. Beide Behandlungen wurden gut vertragen und wiesen vergleichbare Nebenwirkungsprofile auf. Der Antrag des Unternehmens auf ein neues Medikament für OLC wird derzeit geprüft, mit einem kommerziellen Start, der für 2025 geplant ist.
- Successful demonstration of bioequivalence between OLC and established drug Fosrenol®
- NDA under review with planned commercial launch in 2025
- Positive safety profile with well-tolerated results
- Publication in peer-reviewed journal validates study results
- None.
Insights
The publication of OLC's bioequivalence data in Clinical Therapeutics represents a significant milestone for Unicycive's development pipeline. The study effectively demonstrated that OLC matches Fosrenol's pharmacodynamic profile, with comparable reductions in urinary phosphate excretion (
The successful demonstration of bioequivalence strengthens OLC's NDA position and potentially streamlines the regulatory pathway. With 80 participants enrolled and 75 completing all doses, the study size provides robust statistical power. The matching safety profile between OLC and lanthanum carbonate further supports the potential for market adoption. The swallowable tablet format of OLC could offer a meaningful advantage over Fosrenol's chewable formulation for patient compliance.
This peer-reviewed publication validates Unicycive's development approach and strengthens their competitive position in the phosphate binder market. For a small-cap company (market cap:
The phosphate binder market represents a substantial commercial opportunity, particularly given the chronic nature of end-stage kidney disease treatment. OLC's differentiated swallowable formulation could capture meaningful market share from existing chewable options. With the NDA under review and commercial preparations underway, Unicycive is approaching a critical inflection point that could drive significant value creation.
LOS ALTOS, Calif., Dec. 17, 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 data from the Company’s oxylanthanum carbonate (OLC) bioequivalence study in healthy volunteers was published in the peer-reviewed journal, Clinical Therapeutics.
The publication, entitled, “Two-Way Randomized Crossover Study to Establish Pharmacodynamic Bioequivalence Between Oxylanthanum Carbonate and Lanthanum Carbonate” described the study that established pharmacodynamic (PD) bioequivalence of OLC to Fosrenol®. In the study, OLC was well tolerated and demonstrated bioequivalence to lanthanum carbonate (LC).
“Demonstrating bioequivalence was a key component of our OLC New Drug Application, and we are pleased that these positive data have been published in the peer-reviewed journal, Clinical Therapeutics,” said, Shalabh Gupta, MD, Chief Executive Officer of Unicycive. “With our NDA now under review, we are preparing for commercial launch of OLC in 2025.”
Phosphate binders are integral to hyperphosphatemia management in patients with end-stage kidney disease. This objective of the Unicycive study was to demonstrate the pharmacodynamic equivalence of orally administered OLC to LC in healthy participants. A total of 80 participants were randomized and 75 received all doses. Participants were treated with OLC swallowable 1000 mg tablets three times/day and LC chewable 1000 mg tablets three times/day in a two-way crossover design. The primary pharmacodynamic variable was the least squares mean (LSM) change in urinary phosphate excretion from baseline to the evaluation period (Days 1–4 of treatment). The LSM change in urinary phosphate excretion from Baseline to the Evaluation (Treatment) Period was similar for both OLC (–320.4 mg/day [
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.
Fosrenol® is a registered trademark of Shire International Licensing BV.
1Reason Research, LLC 2022 survey. Results here.
2 Fortune Business InsightsTM, 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
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