According to the company, full enrollment anticipated by first week of September. The phase 2 trial is designed as potential registration trial with pre-specified primary efficacy endpoints covering both a sign and symptom of DED.
OKYO Pharma Limited announced it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial (NCT05759208) of topical ocular OK-101 to treat dry eye disease (DED).
Gary S Jacob, PhD, CEO of OKYO Pharma, said in a news release the company is pleased with the speed it has been able to achieve in the clinical trial of OK-101 to treat patients diagnosed with DED.
“This trial began in May of this year, with the first patient being randomized in June into one of the three cohorts,” he said in the news release. “Having enrolled 90% of the patients in this trial is an important milestone for OKYO Pharma.”
Jacobs said in the news release the company currently has 216 patients enrolled in the trial and are anticipating completing full enrollment by the first week in September.
“Moreover, the pace at which we are enrolling patients has been encouraging in moving us toward our planned release of top-line data by end of 4Q 2023,” he said in the release.
According to the company, OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is usually found on immune cells of the eye responsible for the inflammatory response.
The therapeutic was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease, according to the company, which also noted in its news release that 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.
Raj Patil, PhD, CSO of OKYO Pharma, said in the release the Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in a larger patient population.
“We sincerely appreciate the clinicians and staff that are contributing to the conduct of this trial and are extremely grateful to the patients that have chosen to participate,” Patil said in the news release.
Patil also noted the company is focused on completing the trial, which is being managed by the OKYO Pharma’s clinical development partner Ora Inc.
According to the company, the phase 2, multi-center, randomized, double–blinded, placebo-controlled study is designed to enroll approximately 240 subjects with DED who are being randomly divided into 3 cohorts of 80 patients. The company is selecting participants 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 company noted in the news release 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 treatment. The protocol for the study includes two prespecified primary endpoints and a number of secondary endpoints.