OKYO Pharma Limited announced that its first drug candidate OK-101, presently in a 240-patient double-blind placebo-controlled phase 2 trial in patients with DED is currently showing a positive safety profile in the ongoing study. Patients continue in the study, and double-blind procedures are still in effect until all patients complete the 12-week dosing duration. OKYO will continue to monitor the trial progress and the safety profile until the release of top-line data in December 2023.

The assignment of 240 DED patients to treatment is now complete, with 230 (95%) patients having completed 4 weeks of dosing, 174 patients (72%) completing 8 weeks of dosing, and 17 patients completing 12 weeks of dosing. OK-101 is well tolerated, with patients continuing on the trial without a dose change. A key need for any drug's approval is not only its efficacy in treating the disease but its tolerability, particularly for chronic conditions where drug dosing is anticipated to last for years.

In that instance, the side effect profile becomes a major concern, and although it is early in evaluation of OK-101 in the current Phase 2 trial, the company is encouraged by what are seeing with the administration of OK-101 to patients with DED. Furthermore, the company is very pleased with the low level of dropouts are seeing in this ongoing trial as well as the high 72% retention rate at 8 weeks. The Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in the population of 240 DED patients comprising this study Without unblinding the data, are excited to observe that OK-101 is showing a very favorable safety profile in DED patients.

DED is a common condition that occurs when one's tears are unable to adequately lubricate the eyes. This condition affects approximately 49 million people in the United States alone and has been difficult to positively diagnose and treat due to the multifactorial nature of the condition. Several contributing factors can lead to this condition, including age, sex, certain medical conditions, reduced tear production and tear film dysfunction.

Tear film instability typically leads to inflammation and damage to the ocular surface and pain. This phase 2, multi-center, randomized, double?blind, placebo-controlled study is designed to enroll approximately 240 subjects with DED who are being randomly divided into 3 cohorts of 80 patients. Participants were selected based on specific inclusion and exclusion criteria.

The three cohorts include one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101. The drug and placebo, respectively, are being administered in both eyes twice daily for 12 weeks. The duration of a patient's treatment is approximately 14 weeks, including a 2-week run-in period, to address the placebo effect, which is common for trials involving a pain component, followed by 12 weeks of dosing or treatment.

The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints. OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease.

OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid '''anchor' contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment. OK-101 is currently in a Phase 2, multi-center, double-blind, placebo-controlled trial to treat dry eye disease.