The US Food and Drug Administration (FDA) has granted clearance for OKYO Pharma’s investigational new drug (IND) application enabling the commencement of a Phase II clinical trial of OK-101 aimed at treating neuropathic corneal pain (NCP).
A lipid-conjugated chemerin peptide agonist that acts on the chemerin receptor 23 (ChemR23) G-protein coupled receptor, OK-101 is developed leveraging a membrane-anchored-peptide technology.
The single-centre, double-masked, randomised, 12-week, placebo-controlled, open-label trial will evaluate OK-101 versus placebo in patients with NCP.
This trial of the long-acting drug candidate will involve a total of 54 participants.
The primary endpoint will be the Visual Analogue Scale (VAS) pain relief scores.
The design of the trial is structured to provide a statistically valid demonstration of OK-101’s true drug effect on NCP symptoms.
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OKYO plans to initiate the trial in the second quarter of this year.
The study will be led by Tufts Medical Center Research and Academic Programs professor and vice-chair Dr Pedram Hamrah, as the principal investigator.
OK-101 has previously demonstrated clear statistical significance in multiple endpoints during a concluded Phase II trial for dry eye disease (DED).
It also showed anti-inflammatory and pain-reducing activities in mouse models of DED and NCP.
OKYO Pharma CEO Dr Gary Jacob said: “OK-101 recently demonstrated favourable tolerability in a Phase II trial of dry eye patients along with statistically significant improvements in dry eye symptoms such as stinging/burning and blurred vision, which are also hallmarks of NCP.
“We are looking forward to advancing OK-101 to potentially treat NCP, a chronically painful ocular disease with no FDA-approved therapy and a major unmet medical need for patients suffering from this condition.”