OKYO Pharma Limited ("OKYO" or the "Company") to File IND in Q3 2022 for OK-101 to treat Dry Eye Disease ("DED") and to go directly to a Phase 2 Human Clinical Efficacy Trial in DED Patients with a planned start date in Q4 2022 on an accelerated basis

OKYO Pharma Limited ("OKYO" or the "Company") to File IND in Q3 2022 for OK-101 to treat Dry Eye Disease ("DED") and to go directly to a Phase 2 Human Clinical Efficacy Trial in DED Patients with a planned start date in Q4 2022 on an accelerated basis

LONDON, Dec. 06, 2021 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF), the biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, is pleased to announce that working with Ora, Inc., a world-class ophthalmic clinical development partner, it is currently anticipating the filing of an IND in Q3 2022 for OK-101 in the treatment of dry eye disease. OK-101, OKYO’s lead pre-clinical compound is a novel long-acting, G protein-coupled receptor-based anti-inflammatory drug candidate.

OK-101 is anticipated to commence human studies with a Phase 2 clinical trial in DED patients in Q4, 2022. The trial is anticipated to be conducted in approximately 100 to 200 DED patients. The study is being designed in conjunction with, and will be managed and monitored by Ora, Inc., well known for its expert leadership of clinical trial activities. The Phase 2 trial is expected to be completed in 6-8 months from enrollment of the first patient.

“Based on the anti-inflammatory response seen in pre-clinical models, this novel mechanism of action may prove to be a breakthrough treatment for the over 700 million DED patients globally,” commented George W. Ousler III, Sr. Vice President, Anterior Segment of Ora, Inc. “Ora is honored to partner with OKYO Pharma to evaluate this promising candidate, and we look forward to moving expeditiously through phase 2 as we work together to elevate the future DED standard of care.”

“We recognize that news-flow from the Company has been limited over the past 9 months, however in that time we have been focused on advancing all necessary IND-enabling studies on OK-101 and are now in a position to announce that we plan to file the IND to treat DED in Q3 2022,” said Gary S Jacob, Ph.D., CEO of OKYO. "Because the drug is designed to be administered topically to dry eye patients, and with the help of Ora’s deeply knowledgeable team with a proven track record of advancing drug development for dry eye as well as other ophthalmic indications, we anticipate skipping standard Phase 1 studies typically expected with orally delivered drug candidates in non-life-threatening conditions and opening the first human trial with OK-101 as a Phase 2 efficacy trial in DED patients. We are accordingly delighted to be able to deliver this update announcing a clear and accelerated path into the clinic for OK-101.”

OK-101 is a lipidated chemerin peptide developed to bind to ChemR23 G protein-coupled receptors typically found on immunological cells present in the eye. ChemR23 plays an important role in the inflammatory response, and binding of OK-101 to ChemR23 has been shown to produce anti-inflammatory activity in mouse models of DED. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating DED. OK-101 is also designed to combat washout through the inclusion of a lipid ‘anchor’ within its molecular structure to enhance 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.

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.

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