OKYO Pharma Limited announced a new agreement with Tufts Medical Center to conduct a 40-patient open-label clinical trial evaluating the efficacy and safety of OK-101 in patients with neuropathic corneal pain (“NCP”).
The investigational new drug (IND) application for NCP is planned to be filed in Q4 of 2023, with study enrollment planned to commence shortly after IND allowance by the FDA.
NCP is a debilitating condition characterized by chronic and severe eye discomfort, leading to decreased quality of life for affected individuals. OK-101, a novel and investigational therapeutic developed by OKYO Pharma, offers a promising solution to alleviate the symptoms associated with NCP.
The open-label trial will provide an opportunity to evaluate the safety and efficacy of OK-101 in a real-world clinical setting, fostering a better understanding of its potential benefits for patients.
The trial is anticipated to take 6-9 months to conduct, and is anticipated to have a minor budgetary impact, with a total cost for the trial, including cost of drug manufacture and formulation for investigational use, amounting to under $1 million. NCP remains a major unmet medical need for the ocular community, as there is no FDA-approved drug to treat NCP and this trial provides the opportunity to establish OK-101’s potential to treat this condition.
This NCP trial will be led by Pedram Hamrah, MD, 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. An ophthalmologist and a clinician-scientist, Dr. Hamrah is a leading expert in NCP and co-inventor on the OK-101 patent. He is a member of OKYO’s Scientific Advisory Board and plans to serve as Principal Investigator of the study, which will be conducted at Tufts Medical Center.
This collaborative effort is focused on evaluating OK-101 as a potential non-opioid analgesic to reduce neuropathic corneal pain, a major unmet medical need.
“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,” said Dr. Hamrah. “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.”
Using a mouse model of NCP, pioneered by Dr. Hamrah’s laboratory and which is based on the ligation of the ocular ciliary nerve, OK-101, administered topically to mice, demonstrated a reduced corneal pain response similar to that of gabapentin administered by intraperitoneal injection (a commonly used oral drug for NCP).
These observations demonstrated preclinical ‘proof-of-concept’ for the topical administration of OK-101 as a potential non-opioid analgesic for NCP. Current treatments for NCP are limited to short term NSAIDs, steroids, oral gabapentin and, in severe cases, opioids. Side effects and the risk of addiction to opioids are currently serious ongoing causes of concern.
“We are excited about OK-101’s dual combination of anti-inflammatory ocular activity and NCP reducing activity and are eagerly awaiting the top-line data from the DED trial,” said Dr. Gary S. Jacob, CEO of OKYO. “But we are also eager to move forward with our plan to evaluate this drug to treat NCP, which has gained considerable significance this past year as a major unmet medical need for patients specifically diagnosed with this debilitating ocular condition.”
OK-101 is currently in a phase 2, multi-center, double-masked, placebo-controlled trial of topical ocular OK-101 to treat dry eye disease. This phase 2, multi-center, randomized, double–blinded, placebo-controlled study is planned to enroll approximately 240 subjects with DED who will be randomly divided into three cohorts of 80 patients each.
The three cohorts are 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.
The protocol for the study includes two primary endpoints; and key exploratory and secondary endpoints will be used to inform future studies. Further details regarding the specifics of the trial are posted on the clinicaltrials.gov public website (clinicaltrials.gov Identifier: NCT05759208 or https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).