OKYO Pharma Ltd (NASDAQ:OKYO), a clinical-stage biopharmaceutical company developing treatments for neuropathic corneal pain (NCP), said patients treated with its investigational therapy urcosimod in its recently completed Phase 2 trial showed improvements in corneal nerve structure, a potential indicator of nerve restoration.
The 18-patient, randomized, double-masked, placebo-controlled trial evaluated corneal nerve health using in vivo confocal microscopy.
Patients receiving 0.05% urcosimod showed increases in total nerve fiber count and total nerve fiber length, while the placebo group showed decreases in both measures.
The corneal nerve analyses were exploratory, but the data suggest a potential positive effect of urcosimod on corneal nerve health in NCP patients, according to the company.
“While exploratory, these findings reinforce our long-standing belief that targeting the chemerin receptor pathway may open a new therapeutic avenue for patients with neuropathic corneal pain,” OKYO Pharma’s chief scientific officer Dr Raj Patil said in a statement.
“We are encouraged by the biological activity observed and believe they provide an important foundation for the continued development of urcosimod.”
Dr Pedram Hamrah, the study’s principal investigator and Professor of Ophthalmology at University of South Florida, said the results represent an important step toward establishing additional mechanistic insights for urcosimod in NCP.
“These early nerve regeneration signals are highly encouraging and biologically meaningful,” Dr Hamrah said. “The fact that we are seeing consistent directional improvements in both nerve fiber count and nerve fiber length, suggests that urcosimod may not only reduce pain but also support the restoration of corneal nerve architecture.”
There is currently no US Food and Drug Administration approved drug to treat NCP, a condition that causes severe pain and senitity in the eyes, face or head.
Shares of OKYO added 9.4% in Thursday morning trading at $2.23.