Okyo Pharma’s OK-101 Will Be Evaluated to Treat Neuropathic Corneal Pain in Study at Tufts
Okyo Pharma, which is developing OK-101 to treat the symptoms of dry-eye disease (DED), announced an agreement with Tufts Medical Center in Boston to conduct a 40-patient, open-label, clinical trial evaluating the efficacy and safety of OK-101 in patients with neuropathic corneal pain (NCP) in a real-world setting. The trial is anticipated to be conducted over a period of 6 to 9 months.
According to the company, OK-101 is an investigational lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor that is typically found on immune cells of the eye responsible for the inflammatory response.
The study at Tufts will focus on evaluating OK-101 as a potential nonopioid analgesic to reduce NCP. The company plans to file an investigational new drug (IND) application with the FDA for NCP in Q4 of 2023. Study enrollment is planned to commence shortly after receipt of the IND allowance.
The NCP trial at Tufts will be led by principal investigator Pedram Hamrah, MD, a coinventor on the OK-101 patent, who is Professor and Vice Chair of Research and Academic Programs, Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at Tufts Medical Center.
“NCP, which can exhibit as a severe, chronic, or debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion,” commented Dr. Hamrah in Okyo Pharma’s press release. “However, there are no approved commercial treatments currently available for this condition, and consequently we are looking forward to initiating the clinical trial to investigate the potential efficacy of OK-101 to treat symptoms of NCP.”
Okyo Pharma advised that topical ocular OK-101 is currently being investigated in a phase 2 trial to treat dry eye disease. The multicenter, double-masked, placebo-controlled study is planned to enroll approximately 240 patients with DED who will be randomized to three cohorts composed of 80 patients. The three cohorts are: treatment with placebo; treatment with 0.05% OK-101; and treatment with 0.1% OK-101. The protocol for the study includes two primary endpoints. key exploratory and secondary endpoints will be used to inform future studies, noted the company.