OKYO Pharma CEO Discusses Positive Phase 2 Trial Results for Urcosimod in Treating Neuropathic Corneal Pain.

OKYO Pharma's Phase 2 trial of urcosimod for neuropathic corneal pain showed significant reductions in pain for patients receiving the treatment. The trial was halted early due to positive results, with 17 patients completing 12 weeks of treatment. The condition, characterized by severe nerve pain without FDA-approved treatments, is being pioneered by OKYO Pharma. The company used confocal microscopy to ensure participants truly suffered from neuropathic pain rather than inflammatory causes.

OKYO Pharma Limited has announced positive top-line data from its recently closed Phase 2 trial of urcosimod, a treatment for neuropathic corneal pain (NCP). The trial, conducted at Tufts Medical Center in Boston, MA, was designed to evaluate the efficacy and safety of urcosimod in reducing pain associated with NCP.

The Phase 2 trial was a randomized, double-masked, placebo-controlled study involving 18 patients. The primary endpoint was the change in mean pain scores from baseline to the end of treatment, as measured by a Visual Analogue Scale (VAS) scale of 0-10. The trial was halted early due to promising preliminary data, with 17 patients completing 12 weeks of treatment.

According to OKYO Pharma, per-protocol population results showed a mean pain score of 5.5 in the 0.05% urcosimod group and 2.75 in the placebo group following the 12-week treatment period. Additionally, 75% of patients treated with 0.05% urcosimod in this group achieved greater than 80% improvement in pain severity based on VAS scores. A marked reduction in pain scores for those treated with urcosimod was seen as early as week 4.

In the intent-to-treat population, 67% of patients in the 0.05% urcosimod group demonstrated greater than 50% improvement in pain, compared to 33% in the placebo group. No serious adverse events were reported among the 18 patients throughout the trial period.

OKYO Pharma plans to accelerate clinical development of urcosimod with further trials in the near future. The company has already received Fast Track designation from the FDA, highlighting the urgency of addressing the unmet medical need for patients suffering from NCP.

OKYO Pharma's urcosimod is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, which is typically found on immune cells of the eye responsible for the inflammatory response, as well as on neurons and glial cells in the dorsal root ganglion. The trial's design was rigorous, and the company used confocal microscopy to ensure participants truly suffered from neuropathic pain rather than inflammatory causes.

The trial's early closure due to positive results suggests that urcosimod could be an effective treatment option for NCP. However, the small sample size and single-site trial may limit the generalizability of the results. Further trials will be necessary to confirm the drug's efficacy and safety in a larger and more diverse patient population.

References:
[1] https://www.ophthalmologytimes.com/view/okyo-pharma-announces-positive-results-from-phase-2-trial-of-urcosimod-for-neuropathic-corneal-pain
[2] https://www.nasdaq.com/articles/okyo-pharma-reports-positive-phase-2-trial-results-urcosimod-neuropathic-corneal-pain