OKYO Pharma announced it has filed an investigational new drug (IND) application with the FDA for the development of OK-101 to create a novel long-acting drug candidate for treating dry eye disease (DED). (via)
What is OK-101?
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 and is responsible for the inflammatory response. (via)
How does OK-101 work?
OK-101 was developed using a membrane-anchored-peptide (MAP) technology and has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of DED and corneal neuropathic pain.
It 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.
What led up to this?
In a pre-IND meeting, the FDA met with Ora Inc—a contract research organization for OKYO Pharma— and agreed to a first-in-human phase 2 trial of OK0-101.
Primary and secondary efficacy endpoints were designated, covering both a sign and symptom of DED in the trial’s clinical protocol. By naming primary and secondary efficacy endpoints at this point in the process, if OK-101 meets its primary endpoint, the timeline for the new drug application (NDA) with the FDA could be accelerated.
When should we expect an update?
Ora plans on initiating the first-in-human phase 2 trial of OK-101 in the first quarter of 2023.