Phase 2 study of OK-101 will commence soon as the company hopes the drug will provide an unmet need.

OKYO Pharma – a company focused on drug development in ophthalmology – has announced that its dry eye disease (DED) candidate will be used in a forthcoming phase 2 trial.

OK-101 will be studied in a first-in-human, clinical trial among patients with DED, while OKYO is also in the process of having randomisation codes produced for its double-blinded placebo-controlled research, alongside other activities needed for initiating the trial, including authorisation of clinical sites.

The DED candidate is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is normally present in immune cells of the eye responsible for the inflammatory response.

OK-101 has demonstrated anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and is also designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the drug molecule.

The company anticipates that the study will commence in the first quarter of 2023, with initial top-line data from the trial emerging later this year.

Gary Jacob, chief executive officer of OKYO Pharma, was optimistic about the clinical trial and the possibilities for patients: “Initiation of the first-in-human phase 2 trial for OK-101 to treat DED has been a central and critical goal for the company for the past 18 months.”

He added: “We are excited to be very close now to moving this drug into clinical trials and believe that OK-101 can provide a new way to treat DED patients who are presently not well-served by currently approved drugs.”