OKYO Pharma Limited, an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat dry eye disease (DED) to address the significant unmet need in this multi-billion-dollar market, announced that its planned trial evaluating the efficacy and safety of OK-101 in subjects with DED has been posted on the ClinicalTrials.gov public website (ClinicalTrials.gov Identifier: NCT05759208).
OKYO is presently in the process of activating those clinical sites planned for the trial, and preparing the clinical trial drug product OK-101 for shipment to those sites involved in the double-blind, placebo-controlled trial, along with other activities needed for initiating the trial. OKYO is now anticipating the first-patient first-visit initiation of the trial in early Q2 2023 and still looking to release top-line data from this trial in Q4 2023.
“We are excited to be very close now to moving this drug into its first clinical trial and believe that OK-101 can provide a new way to treat DED patients who are presently not well-served by currently approved drugs” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma Ltd.
OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain; and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.
OKYO Pharma Limited is a life sciences company admitted to listing on NASDAQ and on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain.
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