OKYO Pharma Limited announced it has entered into a new clinical trial agreement with Boston-based Tufts Medical Center to initiate a phase 2 trial that looks to assess the safety and efficacy of its lead candidate OK-101 for the treatment of neuropathic corneal pain (NCP).
Refresh me on the company.
Based in London, United Kingdom, OKYO Pharma is a pre-clinical biopharmaceutical company currently developing novel molecules to treat inflammatory dry eye disease (DED) and chronic pain.
Now what is OK-101?
OK-101 is a lipid-conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor, which is usually found on immune cells of the eye and is responsible for the inflammatory response.
It was developed using Okyo Pharma’s membrane-anchored-peptide (MAP) technology to produce a novel long-active candidate for DED.
How does it work?
The investigational therapeutic is designed to prevent 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.
Pre-clinical data has also demonstrated it can produce anti-inflammatory and pain-reducing activities in mouse models of DED and NCP.
How far into the clinical process is it?
OKYO Pharma filed an investigational new drug (IND) application for OK-101 (to treat DED) with the FDA in November 2022.
In April 2023, the company activated the first U.S. clinical trial site for its first-in-human (FIH) phase 2 multi-center, placebo-controlled trial (NCT05759208) of OK-101 for DED, which was followed by randomized dosing of participants in June 2023.
Topline data is expected in Q4 2023.
Gotcha … so what about NCP?
No IND application has been submitted yet … however, preclinical data from a ciliary nerve ligation model on mice found that OK-101 reduced NCP response similar to that of gabapentin (a common oral drug used for such pain), administered via intraperitoneal injection.
The model supported the topical administration of OK-101 as a potential non-opioid analgesic for NCP.
And this upcoming trial?
The open-label phase 2 trial will be assessing OK-101 in a real-world setting in patients (n = 40) with NCP.
According to the company, the study is being conducted at Tufts Medical Center and is expected to be conducted for 6 to 9 months, with the total cost coming in under $1 million (which would include funding for drug manufacture and formulation for investigational use).
Who’s leading it?
The principal investigator will be Pedram Hamrah, MD, professor and vice chair of Research and Academic Programs as well as co-director and director of the Center for Translational Ocular Immunology at Tufts Medical Center, and a member of OKYO Pharma’s Scientific Advisory Board.
To note, the pre-clinical mouse model data on OK-101 for NCP was pioneered by Dr. Hamrah and his laboratory.
So what’s next?
The company plans on folding an IND application for NCP by Q4 2023, with “study enrollment planned to commence shortly after IND allowance by the FDA.”