Unicycive Therapeutics achieves study objective in OLC clinical trial

Unicycive Therapeutics announced results from the Oxylanthanum Carbonate UNI-OLC-201 pivotal clinical trial with regard to both safety and tolerability endpoints. OLC 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. The study established promising tolerability of OLC at clinically effective doses in CKD patients on hemodialysis. In terms of tolerability, OLC had a low rate of discontinuation due to adverse events with only 5/86 patients discontinuing from the Study. Of the 5 discontinuations, 3 were treatment-related and 2 were not related to treatment. Importantly, the Company believes the low discontinuation rate for OLC compares favorably to a discontinuation rate due to AEs of 14% for Fosrenol from its U.S. Food and Drug Administration-approved Package Insert. The primary endpoint was defined as the rate of discontinuations due to treatment-related AEs leading to discontinuation in the maintenance period. In the UNI-OLC-201 trial, there was only 1 discontinuation due to a treatment-related AE in the Evaluable Population, a rate of 1.4%. In the full Safety Population, a total of 3 patients discontinued due to treatment-related AEs, a rate of 3.5%. The secondary endpoint assessing safety was also favorable as most treatment-related AEs were mild to moderate in severity and there were no treatment-related serious adverse events reported in the Safety Population. The treatment-related AEs reported in greater than or equal to5% of patients were diarrhea and vomiting which also compares favorably to Fosrenol and other phosphate binders on the market. While the study was not designed to evaluate efficacy, the trial enrolled patients on stable doses of approved hyperphosphatemia medications. At baseline approximately 59% of patients had phosphate levels less than or equal to5.5 mg/dL, the level recommended by KDOQI guidelines. After washout from the prior phosphate binders, 90% of patients were able to achieve phosphate levels less than or equal to5.5ng/dL at the end of titration with OLC.