OKYO Pharma Ltd (NASDAQ:OKYO) told investors that it is on track to release top-line results from its phase 2 clinical trial of OK-101 to treat dry eye disease (DED) this month after the last patient completed the 12-week OK-101 dosing study.
The clinical-stage drug developer said data analysis plans for the 240-patient double-blind placebo-controlled trial have now been finalized and submitted to the US Food and Drug Administration (FDA) for feedback, in anticipation of database lock, subsequent data analysis, and reporting of top-line findings on OK-101.
“OK-101 has been shown in pre-clinical animal studies to display dual-action anti-inflammatory and neuropathic corneal pain-reducing activities and we are eagerly awaiting the results of this first clinical trial of OK-101 in patients to assess the drug’s potential to treat DED,” OKYO CEO Dr Gary Jacob said in a statement.
OKYO’s chief scientific officer Dr Raj Patil added: “The successful execution of this Phase 2 clinical trial is a crucial step in exploring OK-101’s safety, efficacy, and tolerability in DED patients.
“We remain committed to establishing the potential of OK-101 to treat the millions of people currently suffering from DED.”
DED is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the United States alone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition.
OKYO Pharma is focusing on the discovery and development of novel molecules to treat inflammatory DED and ocular pain.
Its therapeutic candidate 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.
OKYO's shares rose 1.2% to $1.70 by midday in New York.
~Updated with share price movement~
Contact the author at stephen.gunnion@proactiveinvestors.com