Okyo Pharma reports Phase 2 clinical trial results for urcosimod

OKYO Pharma (OKYO) announced top-line data from the recently closed 18-patient Phase 2 trial of urcosimod to treat NCP. OKYO is the first company to conduct a clinical study to treat NCP disease, a major unmet medical need. This randomized, double-masked, placebo-controlled, Phase 2 Proof-of-Concept trial of urcosimod to treat NCP was conducted at a single trial site at Tufts Medical Center in Boston, MA, with Pedram Hamrah, M.D., a leading expert in NCP, as Principal Investigator. Note: Primary Endpoint of Phase 2 trial was change in mean pain scores from baseline to end of treatment, as measured by a VAS scale of 0-10. For the per-protocol population, change in mean pain score was 5.5 in the 0.05% urcosimod group and 2.75 in the placebo group, reflecting a 2.75 delta difference between drug and placebo following the 12-week treatment period. Notably, 75% of patients treated with 0.05% urcosimod in this group achieved greater than 80% improvement in pain severity based on VAS scores. Urcosimod demonstrated a marked reduction in pain scores as early as Week 4, with a mean change of 5.25 compared to 3.0 in placebo group. Moreover, for the 0.05% urcosimod group a statistically significant reduction in mean pain scores was observed from Visit 1 to the end of treatment Visit 4. The placebo group also showed a statistically significant improvement from baseline to the final visit, with a p-value = 0.035. However, mean improvement seen in the placebo group was only half what was seen for the 0.05% urcosimod group. Moreover, for the placebo group’s reduction from Visit 1 to the end of treatment Visit 4, 75% of those patients had only mild NCP pain scores at baseline. In contrast, all the patients in the 0.05% urcosimod group had moderate to severe NCP pain scores, indicating a more challenging baseline condition. In the intent-to-treat population, 67% of patients in the 0.05% urcosimod group demonstrated greater than 50% improvement in pain, as measured by VAS scores, compared to 33% in the placebo group. The mean reduction in pain severity from baseline to end of treatment, measured by VAS, was 4.2 in the 0.05% urcosimod group and 2.5 in the placebo group. The drug-effect size of 0.05% urcosimod when compared to placebo at week 12, using Cohen-d demonstrated a strong treatment effect. Cohen-d is a standard statistical measure used to assess and compare the effect size of the trial drug relative to the placebo. In line with earlier findings from a previously conducted Phase 2 trial to evaluate urcosimod to treat dry eye disease, results from the 0.1% drug treatment group in this trial also showed less efficacy than the 0.05% drug treatment group. OKYO is continuing to evaluate additional data and plans to present a larger data set from the study after ongoing analyses of the data have been completed.