According to the company, the OK-101 phase 2 trial will incorporate primary and secondary efficacy endpoints characterizing signs and symptoms of dry eye disease.
Okyo Pharma Ltd., today announced that it filed an Investigational New Drug (IND) application with the FDA for the development of OK-101 to treat dry eye disease (DED).
According to the company’s news release, both nonclinical and clinical development plans on OK-101 were reviewed with the FDA in an earlier Pre-IND meeting facilitated by OKYO’s contract research organization, Ora Inc, with the FDA agreeing to a first-in-human Phase 2 trial in DED patients. FDA also concurred with Okyo’s plans for designating primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the trial’s clinical protocol.
According to the company, OK-101 is a lipid conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response.
Moreover, the company noted that OK-101 has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED and corneal neuropathic pain, respectively, and is designed to combat washout through the inclusion of the lipid “anchor” contained in the drug molecule to enhance the residence time of OK-101 within the ocular environment.
Gary S. Jacob, PhD, CEO of OKYO Pharma, pointed out in the news release that the company’s IND filing with the FDA is a key step for Okyo as it advances its plan to open a phase 2 trial in DED patients in the first quarter of 2023.
“We were pleased with the clear guidance we received from the FDA Pre-IND meeting earlier in the year,’ Jacob said in the news release. “The fact that we are designating primary and secondary efficacy endpoints in this first-in-human trial is highly significant as should our upcoming trial of OK-101 meet its prespecified primary endpoint, it could accelerate the timeline to a new drug application (NDA) filing with the FDA.”
George Ousler, senior vice president for Ora, pointed out in the news release that the FDA’s earlier feedback from the Pre-IND meeting confirmed our plans for the first-in-human study design to determine the safety and efficacy of OK-101 for the treatment of dry eye.
“Ora is looking forward to initiating the trial with OKYO and evaluating this innovative therapy to potentially help millions of patients suffering from this debilitating disease,” Ousler said in a statement.
Raj Patil, Ph.D., CSO of Okyo Pharma, also explained that the IND filing was a key goal for the copany.
“The successful filing of this IND on OK-101 has been a central and critical goal for the company this past year,” Patil said in the news release. “We are excited to be moving this drug into clinical trials early next year and believe that OK-101 can provide a new way to treat DED patients who are presently not well-served by currently approved drugs.”