OKYO Pharma announces dosing of first patient in randomized portion of phase 2 trial of OK-101

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The topical drug is being tested in a multi-center, double-masked, placebo-controlled trial to treat dry eye disease (DED).

a doctor administering eye drops to a patient in the office. (Image Credit: AdobeStock/RFBSIP)

(Image Credit: AdobeStock/RFBSIP)

OKYO Pharma announced the first patient dosing in its double-masked, placebo-controlled trial of OK-101, which is being developed to treat dry eye disease (DED).1 This is following the 2-week placebo run-in period intended to minimize the placebo effect.

OKYO Pharma described OK-101 as 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.” The company also stated OK-101 was developed using a “membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease.”

The CEO of OKYO Pharma, Gary S. Jacob, PhD, discussed the 2-week placebo run-on period in a press release from the company.

“A two-week placebo run-in period involving topical ocular dosing of placebo is an innovative approach used by our clinical development partner, Ora Inc. This design feature reduces the well-known placebo effect for ocular trials such as ours that include an ocular discomfort readout,” said Jacob. “This run-in period enables us to evaluate potential patients for the placebo effect during the run-in screening period, improving patient selection for the randomized treatment portion of the trial. Importantly, this first clinical study is also designed to include two pre-specified primary efficacy endpoints which are the hallmark of phase 3 registration trials, and one of the efficacy endpoints deals specifically with ocular discomfort.”

Previously, the company had announced the first patient had been screened for the trial at the beginning of May 2023.2

“The initiation of this trial of topically applied OK-101 to treat dry eye disease marks a significant step for the company as we have been laser focused on moving this drug candidate into clinical trials over the last 18 months,” said Jacob in a press release. “Importantly, this first clinical study is designed to include pre-specified primary efficacy endpoints which are the hallmark of phase 3 registration trials, and the results from this trial are anticipated before the end of this year. The drug has been shown in pre-clinical studies to have potent anti-inflammatory and neuropathic corneal pain activities, and we are eager to evaluate its potential benefits in the clinic.”

OKYO gave insight into the phase 2 trail design in a press release and stated the study is planned to enroll approximately 240 subjects with DED who will be randomly divided into 3 cohorts of 80 patients. Participants will be selected based on specific inclusion and exclusion criteria. The 3 cohorts will be comprised of one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the third cohort receiving 0.1% OK-101.

Furthermore, the drug and placebo will be administered in both eyes twice daily for 12 weeks. The duration of a patient’s treatment will be approximately 14 weeks, including a 2-week run-in period and 12 weeks of treatment.

According to the company, top-line data from the trial is anticipated in Q4 of 2023.

References:
  1. OKYO Pharma Announces Randomized Segment Now Underway in Phase 2 Clinical Trial of Topical Ocular OK-101 for Dry Eye Disease. Press Release. OKYO Pharma; June 6, 2023. Accessed June 8, 2023. https://www.globenewswire.com/news-release/2023/06/06/2682944/0/en/OKYO-Pharma-Announces-Randomized-Segment-Now-Underway-in-Phase-2-Clinical-Trial-of-Topical-Ocular-OK-101-for-Dry-Eye-Disease.html
  2. OKYO Pharma Announces First-Patient First-Visit for Phase 2 Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye Disease. Press release. OKYO Pharma; May 2, 2023. Accessed June 8, 2023. https://okyopharma.com/okyo-pharma-announces-first-patient-first-visit-for-phase-2-trial-evaluating-efficacy-and-safety-of-ok-101-in-patients-with-dry-eye-disease/
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