OKYO Pharma to Speed Up Urcosimod's Clinical Development for Neuropathic Corneal Pain

OKYO Pharma Limited, a company focused on ophthalmology, is advancing the development of urcosimod for treating Neuropathic Corneal Pain (NCP), a severe ocular condition lacking FDA-approved treatments. Urcosimod, formerly known as OK-101, is being further developed following an early conclusion of its Phase 2 trial. This trial took place at Tufts Medical Center in Boston and involved 17 patients who have completed the study. These participants suffered from chronic neuropathic corneal pain and had limited success with prior therapies.

The decision to conclude the trial early was driven by OKYO's desire to analyze the masked data quickly and plan an expanded development program. The company intends to conduct a multicenter trial, given the significant interest from potential patients for future participation. OKYO also seeks to arrange compassionate use of urcosimod for patients who completed the trial, subject to FDA approval.

Gary S. Jacob, Ph.D., CEO of OKYO Pharma, emphasized the strategic advantage of ending the trial early to expedite a meeting with the FDA. The analysis of the trial data is expected to take about six weeks. Previous studies of urcosimod demonstrated favorable safety and tolerability. The early closure of the trial is anticipated to speed up the process of requesting an end-of-phase 2 meeting with the FDA to discuss the next steps for urcosimod's clinical development. Jacob expressed gratitude to the patients and research team for their involvement and dedication to this vital trial.

Neuropathic corneal pain is characterized by severe and chronic pain in the eyes, often linked to nerve damage and inflammation. Despite various off-label treatments, there is no FDA-approved medication specifically for this condition. The Phase 2 study for NCP was a double-masked, placebo-controlled trial planned to include 48 patients confirmed to have NCP via confocal microscopy.

Urcosimod acts as a lipid-conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, found on immune and nerve cells related to inflammatory responses. This drug was developed using a membrane-anchored-peptide technology to create a novel, long-acting treatment option for dry eye disease. Urcosimod has shown promising anti-inflammatory and analgesic effects in animal studies on dry eye disease and neuropathic corneal pain, potentially increasing its residence time in the eye due to its lipid anchor. The drug demonstrated significant statistical improvements in a recent Phase 2 trial for dry eye disease and is now being assessed in a similar trial for NCP patients.

OKYO Pharma Limited, listed on the NASDAQ, is a biopharmaceutical company at the clinical stage, specializing in novel therapeutic solutions for neuropathic corneal pain and dry eye disease. The company has completed a Phase 2 trial of urcosimod for dry eye disease and is actively investigating its application for treating neuropathic corneal pain.