OKYO Pharma's Drug OK-101 Clears Customs in the US; To Be Used In Phase 2, First-In-Human, Clinical Trial For Patients With Dry Eye Disease

OKYO Pharma Limited OKYO OKYO recently announced that its GMP packaged OK-101 drug to be used in the upcoming Phase 2, first-in-human, clinical trial in patients with DED, which was recently shipped from Europe, has cleared customs in the United States.

OKYO is now in the process of having randomization codes generated for its double blinded placebo-controlled trial, along with other activities needed for initiating the trial, including authorization of those clinical sites planned for the Phase 2 clinical trial. Once these activities are completed, the drug for the study is planned to be shipped to those sites involved in the trial. OKYO is anticipating the first-patient-first visit in Q1 2023 and looking to release top-line data from this trial in Q4 2023.

“Initiation of the first-in-human Phase 2 trial for OK-101 to treat DED has been a central and critical goal for the company for the past 18 months,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma Ltd.  “We are excited to be very close now to moving this drug into clinical trials and believe that OK-101 can provide a new way to treat DED patients who are presently not well-served by currently approved drugs.”

About OK-101

OK-101 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. OK-101 has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment.

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