OKYO Pharma Begins Phase 2 Trial for Neuropathic Corneal Pain

OKYO Pharma Limited, listed on NASDAQ under the ticker OKYO, has initiated screening and recruitment for a Phase 2 clinical trial of OK-101 aimed at treating neuropathic corneal pain (NCP). NCP, recognized by the National Organization for Rare Disorders (NORD) as an orphan disease, is a debilitating condition without currently approved treatments. This trial represents a significant step towards addressing this unmet medical need.

The Phase 2 trial is a double-masked, randomized, placebo-controlled study set to span 12 weeks and involve 48 participants. These participants have been confirmed to have NCP through confocal microscopy, a diagnostic tool that allows for detailed imaging of the cornea. The primary objective of the trial is to assess pain relief using the Visual Analog Scale (VAS), a standard measure for pain intensity.

NCP is a condition characterized by chronic eye pain and sensitivity, often resulting from nerve damage combined with inflammation. Currently, NCP patients are treated with various off-label topical and systemic therapies, as no specific treatments have received FDA approval. This trial seeks to fill this therapeutic void by evaluating the efficacy of OK-101.

Previously, OK-101 has shown promising results in a Phase 2 trial for dry eye disease (DED), demonstrating significant improvements in symptoms like stinging, burning, and ocular pain, which are also relevant to NCP. In pre-clinical studies, particularly using a mouse model, OK-101 effectively reduced neuropathic corneal pain, further supporting its potential efficacy in human patients.

The trial is being conducted at Tufts Medical Center, with Dr. Pedram Hamrah serving as the Principal Investigator. Dr. Hamrah, a prominent figure in ocular immunology, is highly regarded for his expertise in NCP and is also a co-inventor of the OK-101 patent. His involvement underscores the trial's scientific rigor and potential for success.

Dr. Hamrah expressed his enthusiasm for the trial, highlighting the carefully designed protocol developed in collaboration with the FDA. He emphasized the trial's importance in potentially bringing a new effective treatment to NCP patients. OKYO Pharma's CEO, Gary S. Jacob, echoed these sentiments, noting that the initiation of this trial marks a crucial milestone for the company. Jacob pointed out that this Phase 2 trial builds on the successful results of a previous trial involving 240 DED patients, which showed significant reductions in ocular pain.

OK-101 is a lipid conjugated chemerin peptide agonist targeting the ChemR23 G-protein coupled receptor, commonly found on immune cells in the eye. This receptor is involved in the inflammatory response, and OK-101's design allows for prolonged action within the ocular environment, thanks to a built-in lipid anchor. This feature helps prevent the drug from being washed out, enhancing its effectiveness.

OKYO Pharma Limited is a clinical-stage biopharmaceutical company focused on developing innovative treatments for inflammatory ocular diseases, including DED and NCP. With its recent advancements, the company is at the forefront of discovering novel therapeutic molecules to address these conditions. The ongoing Phase 2 trial for OK-101 represents a pivotal effort in potentially bringing a new treatment option to NCP patients, addressing a significant unmet medical need in the field of ophthalmology.