OKYO Pharma Unveils Strong Phase 2 Clinical Trial Results for Urcosimod to Treat Neuropathic Corneal Pain

Core Insights - OKYO Pharma Limited announced positive top-line data from an 18-patient Phase 2 trial of urcosimod for treating neuropathic corneal pain (NCP), a condition with no FDA-approved therapy [1][8] - The trial demonstrated significant pain reduction in patients treated with urcosimod compared to placebo, indicating its potential effectiveness [4][5] Trial Details - The Phase 2 trial was a randomized, double-masked, placebo-controlled study conducted at Tufts Medical Center in Boston, MA, led by Dr. Pedram Hamrah [2][12] - The primary endpoint was the change in mean pain scores from baseline to the end of treatment, measured by a Visual Analogue Scale (VAS) [3] Results Summary - In the per-protocol population, the mean pain score change was 5.5 for the 0.05% urcosimod group versus 2.75 for the placebo group, showing a delta difference of 2.75 [4] - 75% of patients in the urcosimod group achieved over 80% improvement in pain severity, with significant reductions observed as early as Week 4 [8] - In the intent-to-treat population, 67% of patients in the urcosimod group showed greater than 50% improvement in pain compared to 33% in the placebo group [5] Statistical Significance - A statistically significant reduction in mean pain scores was observed in the urcosimod group (p-value = 0.025), while the placebo group also showed improvement (p-value = 0.035) [4][8] - The drug-effect size for urcosimod compared to placebo at week 12 demonstrated a strong treatment effect (Cohen-d value > 1.2) [6] Future Plans - Following the trial, OKYO plans to meet with the FDA to discuss next steps for urcosimod, which has received Fast Track designation for treating NCP [8] - The company is also considering the "Expanded Access" program for patients who completed the trial [9] About Urcosimod - Urcosimod is a lipid conjugated chemerin peptide agonist designed to treat ocular diseases, showing anti-inflammatory and pain-reducing activities in preclinical models [13] - The drug has previously shown efficacy in a Phase 2 trial for dry eye disease, indicating its potential across multiple ocular conditions [10]