OKYO Pharma Plans to Initiate Phase 2 Trial of OK-101 in Neuropathic Corneal Pain (“NCP”) Following Announcement of Clinical Trial Agreement with Tufts Medical Center - Seite 2

“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+Synd ...).