OKYO Pharma Initiates Phase 2 Trial of OK-101 for Neuropathic Corneal Pain (NCP) in Collaboration with Tufts Medical Center
Date: July 28, 2023
Introduction: OKYO Pharma Limited, a leading bio-pharmaceutical company focusing on ophthalmology, announces an exciting development in its mission to address unmet medical needs. The company has entered into a clinical trial agreement with Tufts Medical Center to conduct a 40-patient open-label trial to evaluate the effectiveness and safety of its groundbreaking therapeutic, OK-101, in treating neuropathic corneal pain (NCP). This promising partnership aims to provide hope for patients suffering from chronic and severe eye discomfort, a condition with no FDA-approved treatment options.
Key Highlights:
- OKYO Pharma Limited (Nasdaq: OKYO) announces a new clinical trial agreement with Tufts Medical Center to evaluate OK-101’s efficacy in treating neuropathic corneal pain (NCP).
- NCP is a debilitating condition causing chronic eye discomfort and diminished quality of life.
- OK-101, a novel lipid-conjugated chemerin peptide agonist, offers potential as a non-opioid analgesic to alleviate NCP symptoms.
- Dr. Pedram Hamrah, a renowned expert in NCP and co-inventor of the OK-101 patent, will lead the trial at Tufts Medical Center.
- The Investigational New Drug (IND) application for NCP is scheduled for submission in Q4 2023, with the trial expected to commence shortly after FDA approval.
The Unmet Need: Neuropathic corneal pain (NCP) is a severe and chronic eye condition that significantly impairs the daily lives of affected individuals. Current treatment options are limited to off-label topical and systemic medications, leaving patients with a pressing unmet medical need. However, OK-101’s preclinical ‘proof-of-concept’ study, conducted using a mouse model of NCP, has shown promising results in reducing corneal pain response, offering hope for a much-needed treatment solution.
OK-101’s Potential: OK-101 is a lipid-conjugated chemerin peptide agonist that targets the ChemR23 G-protein coupled receptor present on immune cells responsible for ocular inflammation. Developed using a membrane-anchored-peptide (MAP) technology, this innovative drug candidate has demonstrated anti-inflammatory and pain-reducing activities in both NCP and dry eye disease mouse models. These findings have sparked enthusiasm among researchers and clinicians, as they suggest a potential breakthrough in managing NCP without the risk of opioid-related side effects or addiction.
The Clinical Trial: The 40-patient open-label trial, set to be conducted at Tufts Medical Center under the leadership of Dr. Pedram Hamrah, is projected to last 6-9 months with a cost of under $1 million. The trial aims to evaluate OK-101’s efficacy in a real-world clinical setting, furthering our understanding of its potential benefits for patients. The forthcoming Investigational New Drug (IND) application filing in Q4 2023 marks a significant milestone in OKYO Pharma’s mission to address NCP’s unmet medical needs.
Conclusion: OKYO Pharma’s partnership with Tufts Medical Center represents a crucial step in advancing therapeutic solutions for neuropathic corneal pain (NCP). By focusing on developing OK-101 as a non-opioid analgesic, OKYO Pharma aims to improve the lives of patients suffering from this debilitating ocular condition. The company’s commitment to innovation and patient care drives its efforts in providing effective and safe treatments for inflammatory dry eye diseases and chronic pain.
For more information about OKYO Pharma’s groundbreaking research and its dedication to improving ocular health, please visit www.okyopharma.com.
