OKYO Pharma Limited (NASDAQ: OKYO) has announced the dosing of the first patient in its Phase 2 clinical trial of OK-101, a topical ocular therapy for neuropathic corneal pain (NCP). This marks a significant step forward in the development of a potential treatment for this debilitating condition, which currently lacks FDA-approved therapies.
The Phase 2 study is designed as a double-masked, randomized, 12-week placebo-controlled trial, with a planned enrollment of 48 patients diagnosed with NCP confirmed via confocal microscopy. The trial aims to evaluate the safety and efficacy of OK-101 in alleviating the chronic pain associated with corneal nerve damage.
Addressing an Unmet Need in Neuropathic Corneal Pain
NCP is characterized by persistent pain and sensitivity in the eyes, face, or head, often resulting from corneal nerve damage and inflammation. Conditions such as dry eye disease, surgical interventions, or infections can trigger NCP, significantly impacting a patient's quality of life. Current management strategies are limited to off-label pain relief methods that provide only temporary or partial relief.
"Enrolling the first patient in this clinical trial is an important first step towards our goal of determining the safety and efficacy of OK-101 for the treatment of NCP," said Dr. Pedram Hamrah, MD, of Tufts Medical Center, the trial's Principal Investigator. "There is a significant, unmet need for an approved therapy to help mitigate eye pain in patients with NCP around the world."
OK-101: A Novel Therapeutic Approach
OK-101 is a novel, non-opioid therapeutic candidate designed to target and alleviate pain associated with corneal nerve damage. It is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor, typically found on immune cells of the eye responsible for the inflammatory response. The drug was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease and NCP.
Preclinical studies have demonstrated OK-101's anti-inflammatory and pain-relieving properties in mouse models of dry eye disease and NCP. The drug's unique lipid anchor is designed to enhance its residence time within the ocular environment, combating washout and potentially prolonging its therapeutic effects. OK-101 has also shown statistically significant improvements in dry eye symptoms such as stinging, burning, and ocular pain in a Phase 2 trial for dry eye disease.
Trial Design and Endpoints
The Phase 2 trial's primary endpoint is to measure pain relief using the Visual Analog Scale (VAS). Secondary endpoints will assess other relevant clinical parameters and safety measures.
"We are excited to announce the enrollment of the first patient in our Phase 2 clinical trial of OK-101," said Dr. Gary S. Jacob, CEO of OKYO Pharma. "This is a key step forward in our mission to provide relief for patients suffering from neuropathic corneal pain, a chronic condition for which no FDA-approved treatments exist today."
OKYO Pharma is committed to advancing the development of OK-101 as a potential breakthrough therapy for NCP, addressing a significant unmet medical need in ophthalmology.
