OKYO Pharma to Start Neuropathic Corneal Pain Trial for OK-101

OKYO Pharma Limited, a clinical-stage biopharmaceutical company, has announced its plans to commence a Phase 2 clinical trial for its drug OK-101, aimed at treating neuropathic corneal pain (NCP). This trial is scheduled to begin in the third quarter of 2024. OK-101 is perceived to be the first drug to gain FDA IND clearance specifically for treating NCP, a significant unmet medical need.

The drug has shown promising results in previous studies. In a Phase 2 trial for dry eye disease (DED), OK-101 demonstrated statistically significant pain relief from day 29 through the final study visit on day 85. Additionally, it has shown reduced neuropathic corneal pain in a preclinical mouse model. NCP is recognized as a rare disease by the National Organization for Rare Disorders.

OKYO Pharma's objective is to address the considerable market for inflammatory dry eye disease and anterior ocular segment diseases, including NCP, which currently lacks FDA-approved therapies. The planned Phase 2 trial for NCP will be a one-year study, conducted at a single center under the leadership of Dr. Pedram Hamrah of Tufts Medical Center. Dr. Hamrah is a recognized expert in NCP and a co-inventor of the OK-101 patent. He holds positions as Professor, Vice Chair of Research and Academic Programs, Director of the Cornea Service, and Director of the Center for Translational Ocular Immunology at Tufts Medical Center.

Dr. Hamrah expressed enthusiasm for evaluating OK-101's potential for treating NCP in a clinical setting, following productive interactions with the FDA. He emphasized the importance of a rigorous protocol to test their hypothesis on NCP patients.

Dr. Gary S. Jacob, CEO of OKYO, highlighted the significance of OK-101's progress, noting it as the first NCP drug candidate to receive FDA IND clearance for clinical evaluation. He expressed optimism due to the favorable improvements seen in ocular pain in dry eye patients, many of whom experience NCP, as well as the positive outcomes from preclinical models. OK-101 targets a receptor found in neurons and glial cells, addressing a painful ocular disease with no existing FDA-approved therapy. Dr. Jacob emphasized the potential innovation that OK-101 could bring to this unmet medical need.

The Phase 2 NCP trial is designed as a double-masked, randomized, 12-week placebo-controlled study involving 48 NCP patients diagnosed via confocal microscopy. The primary endpoint will be pain improvement measured by a visual analogue scale (VAS) compared to a placebo. The study will include five visits over 16 weeks, with a follow-up visit four weeks after completion.

In the recently concluded Phase 2 DED trial, OK-101 showed significant and lasting pain relief, improved vision clarity, and reduced burning/stinging sensations, starting as early as day 15 and continuing through day 85. Daily diary entries from patients also indicated significant pain reduction within the first two weeks of treatment. In a preclinical mouse model, OK-101 showed a comparable reduction in corneal pain response to gabapentin at day 14 post-surgery.

Neuropathic corneal pain (NCP) is characterized by pain and sensitivity in the eyes, face, or head, likely due to nerve damage in the cornea combined with inflammation. It can manifest as a severe, chronic, or debilitating condition and is currently managed with various off-label topical and systemic treatments, as no approved commercial treatments exist.

OK-101, a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, was developed to treat dry eye disease using membrane-anchored-peptide technology. This technology aims to create a long-acting drug candidate by enhancing the residence time of OK-101 within the ocular environment. It has demonstrated anti-inflammatory and pain-reducing efficacy in mouse models of dry eye disease and corneal neuropathic pain.

OKYO Pharma Limited, listed on the NASDAQ Capital Market, focuses on developing innovative therapies for DED and NCP. The company is committed to addressing inflammatory DED and ocular pain through the discovery and development of novel molecules.