Therapeutics Company Announces Positive Findings From Oxylanthanum Carbonate Clinical Trial
Unicycive Therapeutics Announces Positive Patient Satisfaction Findings from Pivotal Clinical Trial of Oxylanthanum Carbonate (OLC).
Disclaimer: The information presented in this article is intended for informational purposes only and should not be construed as investment advice, medical advice, or an endorsement of any product or company. The details provided are based on the results of a clinical trial conducted by Unicycive Therapeutics, Inc. (Nasdaq: UNCY) and are publicly available. Readers should conduct their own research and consult with professionals before making any decisions related to the content discussed herein.
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Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a clinical-stage biotechnology company committed to developing therapies for patients with kidney disease, recently announced promising initial results from a patient-reported outcome survey conducted during their pivotal clinical trial UNI-OLC-201. This study evaluated oxylanthanum carbonate (OLC) in patients with hyperphosphatemia who have chronic kidney disease and are on dialysis. The top-line results were reported on June 25, 2024, and indicated patient satisfaction and preference for OLC over existing phosphate binders.
Overview of the Clinical Trial
The UNI-OLC-201 trial was designed to assess the efficacy and patient satisfaction related to OLC, a novel phosphate binder. Hyperphosphatemia, characterized by elevated phosphate levels in the blood, is a common complication in patients with chronic kidney disease, particularly those undergoing dialysis. Effective management of phosphate levels is crucial to prevent severe cardiovascular and bone-related complications.
An essential component of the UNI-OLC-201 trial was a satisfaction questionnaire aimed at capturing patients' perspectives on their treatment. This questionnaire was a pre-specified exploratory objective and included questions regarding patient satisfaction, ease of use, and overall preference for OLC compared to their previous phosphate binder therapy. Patients completed the survey at both the start and conclusion of the study, allowing for a comprehensive comparison. Here are some key findings:
Patient Preference: 79% of patients expressed a preference for OLC over their previous phosphate binder. In contrast, 18% preferred their prior therapy, while 3% had no preference.
Ease of Use: A striking 98% of patients found OLC easier to take compared to only 55% for their previous therapy.
Satisfaction Levels: 89% of patients reported being satisfied with OLC, significantly higher than the 49% satisfaction rate with their prior therapy.
Expert Insights
Dr. Shalabh Gupta, Chief Executive Officer of Unicycive, commented on the findings: “We are gratified by the encouraging patient-reported findings from our pivotal trial that mirror the better-than-expected topline clinical results that we reported last month. In the design of our pivotal clinical trial for OLC, we believed that it was important to consider the patient perspective and the personal challenges that they face in managing their hyperphosphatemia. Importantly, the results showed that patients preferred OLC greater than 4 to 1 over their prior phosphate binder therapy. Our focus is now directed toward filing our New Drug Application and making OLC available to patients who may benefit from its potential best-in-class profile, if approved.”
Dr. Pablo Pergola, Research Director at the Clinical Advancement Center, Renal Associates, P.A., and principal investigator for the UNI-OLC-201 trial, also expressed his optimism: “In this clinical study, our patients stated a clear preference for OLC over their prior phosphate-lowering therapies. This positive patient-reported experience with OLC is encouraging because hyperphosphatemia outcomes are often negatively impacted by non-adherence to phosphate-lowering prescriptions due to side effects and high pill burden. At the end of the study, several of my patients asked not to be put back on their prior phosphate binder."
Background on Phosphate Binders
Phosphate binders are a class of medication used to reduce the absorption of phosphate from the intestine, thereby lowering phosphate levels in the blood. Common phosphate binders include:
Renvela® (sevelamer carbonate): Used by 52% of the trial participants.
PhosLo® (calcium acetate): Used by 19%.
Auryxia® (ferric citrate): Used by 15%.
Velphoro® (sucroferric oxyhydroxide): Used by 13%.
Other: Used by 1%.
Before starting the trial, patients underwent a two-week washout period to clear their current phosphate binder from their system.
The most notable finding from the satisfaction survey was the overwhelming preference for OLC. Nearly four out of five patients favored OLC over their previous treatments. This preference could be attributed to several factors, including the efficacy of OLC in controlling phosphate levels and its ease of use. Ease of use is a critical factor in medication adherence, especially for individuals with chronic conditions who must manage multiple medications daily. The fact that 98% of patients found OLC easier to take suggests a improvement in patient experience. Traditional phosphate binders can have a high pill burden and may need to be taken multiple times a day, which can be cumbersome and lead to non-compliance.
High satisfaction levels with OLC (89%) compared to previous therapies (49%) indicate that patients experienced fewer side effects and found the treatment more manageable. This satisfaction is significant because better patient compliance typically leads to improved health outcomes.
Clinical Practice
The results of the UNI-OLC-201 trial have important implications for the management of hyperphosphatemia in patients with chronic kidney disease on dialysis. If approved, OLC could offer a more patient-friendly alternative to existing phosphate binders, potentially improving adherence and outcomes. Clinicians should consider the patient-reported benefits of OLC when prescribing phosphate binders. The preference for OLC over traditional therapies shows the need for treatments that address not only clinical efficacy but also patient quality of life. Unicycive's next steps involve filing a New Drug Application (NDA) to seek approval for OLC. If successful, OLC could become a new standard of care for managing hyperphosphatemia in chronic kidney disease patients on dialysis.
The company's commitment to incorporating patient feedback into their clinical trial design is commendable and sets a precedent for future studies. By prioritizing patient experience, Unicycive aims to develop therapies that are not only effective but also improve the daily lives of those affected by chronic conditions. The initial positive findings from the UNI-OLC-201 trial highlight the potential of oxylanthanum carbonate (OLC) as a superior phosphate binder for patients with chronic kidney disease on dialysis. With high patient satisfaction, ease of use, and a strong preference over existing therapies, OLC represents a promising advancement in the management of hyperphosphatemia.
As Unicycive moves forward with regulatory submissions, the potential approval and subsequent availability of OLC could bring much-needed relief to patients struggling with the challenges of traditional phosphate binders. The emphasis on patient-reported outcomes in this trial presents the importance of considering patient perspectives in clinical research and therapeutic development.
Disclaimer: The information provided in this article is for informational purposes only and should not be interpreted as medical advice, investment advice, or an endorsement of any product or company. Readers are encouraged to conduct their own research and consult with appropriate professionals before making any decisions based on the content discussed.
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