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.
