Unicycive Therapeutics Highlights Innovations at Kidney Week 2024

Author: Addison Perry Updated: 10-14-2024 07:17 AM

Unicycive Therapeutics Showcases Key Research at ASN Kidney Week

LOS ALTOS, Calif. – Unicycive Therapeutics, Inc. (Nasdaq: UNCY), a pioneering biotechnology company focused on developing effective therapies for kidney diseases, has recently made a significant announcement. A poster presentation concerning their innovative treatment Oxylanthanum Carbonate (OLC) was selected for a Late-Breaker session at the American Society of Nephrology (ASN) Kidney Week 2024. Thus, the excitement surrounding OLC continues to build, especially as the company prepares to share more groundbreaking insights into their additional research on both OLC and another candidate, UNI-494.

Details About the Late-Breaking Science Poster

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 at 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

Exciting Additional Presentations

Unicycive will also be delivering three additional poster presentations at Kidney Week, showcasing their comprehensive research efforts:

1. Title: Intravenous UNI-494 Slows Progression or Halts/Reverses Acute Kidney Injury

Lead Author: Satya Medicherla, Ph.D., Vice President of Preclinical Pharmacology at 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

Final Presentation

3. Title: UNI-494 Phase I Safety, Tolerability, and Pharmacokinetics

Lead Author: Guru Reddy, PH.D., Vice President of Preclinical R&D at 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

Understanding Oxylanthanum Carbonate (OLC)

Oxylanthanum carbonate is emerging as a next-generation lanthanum-based phosphate-binding agent, specifically designed for treating hyperphosphatemia in patients suffering from chronic kidney disease (CKD). With over forty patents issued globally, OLC demonstrates potential advantages over existing treatments as it promises to reduce the pill burden for patients, thus likely improving adherence. The results from a survey completed in 2022 indicated that nephrologists are particularly focused on finding solutions that alleviate the pill burden associated with traditional phosphate binders.

A Promising Market Opportunity

The market for addressing hyperphosphatemia is colossal, projected to exceed $2.5 billion with a significant portion attributed to the U.S. This thriving sector continues to emphasize the necessity for effective treatments, as a staggering 75% of dialysis patients in the U.S. do not reach their recommended phosphorus levels, despite the options available.

Regulatory Pathway and Clinical Trials

Unicycive is actively seeking FDA approval for OLC via the 505(b)(2) regulatory pathway. The company has conducted two pivotal clinical studies on healthy volunteers, including a safety and tolerability study, establishing the groundwork for future progress. A key clinical trial also examined the efficacy of OLC in CKD patients on hemodialysis, resulting in favorable outcomes.

About UNI-494

UNI-494 represents an advancement in the treatment of acute kidney injury (AKI). As a novel nicotinamide ester derivative, it uniquely activates mitochondrial potassium channels, spotlighting the importance of mitochondrial function in kidney health. This product is currently undergoing a Phase 1 dose-ranging safety study, with results anticipated soon, further underscoring Unicycive’s commitment to combatting kidney illnesses.

Conclusion

Unicycive Therapeutics continues to make strides in the field of kidney disease therapy, committed to furthering innovation for patients suffering from these conditions. Their upcoming presentations at ASN Kidney Week 2024 signify not only the advancements of OLC and UNI-494 but also the company’s dedication to addressing the serious challenges within nephrology.

Frequently Asked Questions

What is Oxylanthanum Carbonate (OLC)?

OLC is an innovative lanthanum-based phosphate binding agent aimed at treating hyperphosphatemia in chronic kidney disease patients.

When will Unicycive present their research?

Unicycive will present at ASN Kidney Week from October 24-27, 2024.

Who are the lead authors for the presentations?

Lead authors include several prominent professionals, such as Geoffrey A. Block, MD, and Satya Medicherla, Ph.D.

What is the market potential for treating hyperphosphatemia?

The global market for hyperphosphatemia treatments is projected to exceed $2.5 billion with significant unmet needs in patient adherence.

What is the significance of UNI-494?

UNI-494 is potentially a significant advancement in treating acute kidney injury through its unique mechanism of enhancing mitochondrial function.

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