OKYO Pharma Limited ("OKYO" or the "Company") - OKYO Pharma announces Successful Completion of a Pre-IND Meeting with the FDA on the Development of OK-101 to Treat Dry Eye Disease

OKYO Pharma Limited ("OKYO" or the "Company") - OKYO Pharma announces Successful Completion of a Pre-IND Meeting with the FDA on the Development of OK-101 to Treat Dry Eye Disease

OK-101 First-in-Human Trial planned as Phase 2 Trial incorporating Primary Efficacy Endpoints covering Signs and Symptoms of Dry Eye Disease

LONDON and BOSTON, Feb. 15, 2022 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF), a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, today announced the successful completion of a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding the development plans for OK-101 to treat dry eye disease (DED).

Both nonclinical and clinical development milestones were covered in the Pre-IND meeting facilitated by Ora Inc., with the FDA providing guidance on the proposed phase 2 trial in DED patients. FDA concurred with OKYO’s decision to designate co-primary efficacy endpoints covering both a sign and a symptom of dry disease in the clinical protocol of the trial.

“We are thrilled to have clear guidance from the FDA regarding our plans for the clinical development path for OK-101 to treat DED,” said Gary S. Jacob Ph.D., CEO of OKYO Pharma. “We believe that the successful outcome of the pre-IND meeting with FDA will accelerate OKYO’s previously forecasted timeline for an NDA filing and commercialization of the drug. The fact that we are designating efficacy endpoints as primary endpoints in this first-in-human trial is highly significant. Should our upcoming trial meet its prespecified primary endpoints, this would be an important step in reducing the timeline to a new drug application (NDA) filing with the FDA.”

“FDA’s valuable feedback has confirmed 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,” said George Ousler, Senior Vice President for Ora.

“We are on track with our pre-IND work on OK-101 and are planning to file the IND to treat DED in Q3/Q4 2022, followed by the planned commencement of a Phase 2 trial in DED patients in Q4 2022,” said Raj Patil Ph.D., CSO of OKYO Pharma. “We believe that OK-101 can provide a new way to treat DED patients who are presently not well served by drugs currently approved for treating dry eye disease.”

OK-101 is a lipidated chemerin peptide agonist of the ChemR23 G-protein coupled receptor which is typically found on immunological cells of the eye responsible for the inflammatory response. OK-101 has been shown to produce anti-inflammatory and pain-reducing activities in mouse models of dry eye disease and corneal neuropathic pain 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.

The person who arranged for the release of this announcement on behalf of the Company was Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO.

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