OKYO Pharma Limited announced it has submitted an investigational new drug (IND) application for the development of OK-101 to treat neuropathic corneal pain (NCP).
Refresh me on this 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)–more on that in a moment—and chronic pain.
Now 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. Further, this protein is encoded in humans by the CMKLR1 gene.
To note, it was originally developed as a potential novel, long-lasting drug candidate for treating DED, and is also currently in preclinical development for allergic conjunctivitis and uveitis.
How does it 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 NCP.
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.
Didn’t OKYO already file an IND for OK-101?
Good memory! And yes—back in November 2022.
However, this IND was for DED, not NCP.
As for updates on that application …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.
Any data yet on it?
Yes! OKYO actually just released positive safety data from its phase 2 trial on OK-101 for DED. Topline data is expected in December 2023.
See more details here.
How about for NCP?
According to the company, 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.
Gotcha. So what’s next?
Pending FDA acceptance, the company—in partnership with Boston-based Tufts Medical Center—is planning to launch an open-label phase 2 study in Q1 2024, with an anticipated 40 patients to be enrolled.
The goal: to evaluate the safety and efficacy of OK-101 for NCP in a real-world clinical setting.
What else can you tell me?
Per OKYO, the study will be conducted at Tufts Medical Center, with an expected 6 to 9-month study period.
As for costs … it’s expected to clock in at just under $1 million (which would include funding for drug manufacturing 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.
And the significance of this?
With no current FDA-approved drug on the market to treat NCP, this second indication for OK-101 could become the first, proving to be a game changer for patients suffering from this chronic condition.