Unicycive Therapeutics Achieves Study Objective in Oxylanthanum Carbonate (OLC) Pivotal Clinical Trial

Core Insights - Unicycive Therapeutics announced positive results from the pivotal clinical trial of Oxylanthanum Carbonate (OLC), demonstrating favorable tolerability and safety for patients with chronic kidney disease (CKD) [1][2][6] - The company anticipates submitting a New Drug Application (NDA) for OLC in Q3 2024, utilizing the 505(b)(2) regulatory pathway [1][6][24] Summary by Categories Clinical Trial Results - The UNI-OLC-201 trial showed a low discontinuation rate due to adverse events (AEs), with only 6% (5 out of 86 patients) discontinuing, which is significantly lower than the 14% rate for Fosrenol® [2][3] - In the Evaluable Population (n=71), only 1 patient discontinued due to a treatment-related AE, resulting in a rate of 1.4% [3][13] - The full Safety Population (n=86) had a total of 3 treatment-related discontinuations, yielding a rate of 3.5% [3][13] Safety and Tolerability - Most treatment-related AEs were mild to moderate, with no serious adverse events reported [4][13] - The most common AEs were diarrhea (9%) and vomiting (6%), which are comparable to other phosphate binders [4][13] Efficacy Insights - Although the study was not designed to evaluate efficacy, 90% of patients achieved phosphate levels ≤5.5 mg/dL after titration with OLC [5][15] - At baseline, 59% of patients had phosphate levels ≤5.5 mg/dL, and after washout from prior phosphate binders, 90% achieved the target level [5][15] Market Potential - The global market for treating hyperphosphatemia is projected to exceed $2.5 billion in 2023, with the U.S. accounting for over $1 billion [17] - Approximately 40% of dialysis patients struggle to achieve adequate serum phosphate control, highlighting a significant unmet need in the market [6][17] Company Overview - Unicycive Therapeutics is focused on developing novel treatments for kidney diseases, with OLC being a next-generation phosphate binding agent utilizing proprietary nanoparticle technology [1][20][17] - The company has over forty issued and granted patents globally for OLC, which aims to improve patient adherence by reducing the pill burden compared to existing treatments [17][20]