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

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LONDON, Dec. 06, 2021 (GLOBE NEWSWIRE) — OKYO Pharma Restricted (LSE: OKYO; OTCQB: EMMLF), the biotechnology firm targeted on the invention and improvement of novel molecules to deal with inflammatory dry eye illnesses and ocular ache, is happy to announce that working with Ora, Inc., a world-class ophthalmic medical improvement associate, it’s at the moment anticipating the submitting of an IND in Q3 2022 for OK-101 within the remedy of dry eye illness. 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 begin human research with a Part 2 medical trial in DED sufferers in This autumn, 2022. The trial is anticipated to be performed in roughly 100 to 200 DED sufferers. The examine is being designed at the side of, and might be managed and monitored by Ora, Inc., well-known for its skilled management of medical trial actions. The Part 2 trial is predicted to be accomplished in 6-8 months from enrollment of the primary affected person.

“Primarily based on the anti-inflammatory response seen in pre-clinical fashions, this novel mechanism of motion could show to be a breakthrough remedy for the over 700 million DED sufferers globally,” commented George W. Ousler III, Sr. Vice President, Anterior Phase of Ora, Inc. “Ora is honored to associate with OKYO Pharma to guage this promising candidate, and we sit up for shifting expeditiously by way of section 2 as we work collectively to raise the long run DED commonplace of care.”

“We acknowledge that news-flow from the Firm has been restricted over the previous 9 months, nevertheless in that point we’ve got been targeted on advancing all crucial IND-enabling research on OK-101 and at the moment are ready to announce that we plan to file the IND to deal with DED in Q3 2022,” mentioned Gary S Jacob, Ph.D., CEO of OKYO. “As a result of the drug is designed to be administered topically to dry eye sufferers, and with the assistance of Ora’s deeply educated workforce with a confirmed monitor document of advancing drug improvement for dry eye in addition to different ophthalmic indications, we anticipate skipping commonplace Part 1 research sometimes anticipated with orally delivered drug candidates in non-life-threatening situations and opening the primary human trial with OK-101 as a Part 2 efficacy trial in DED sufferers. We’re accordingly delighted to have the ability to ship this replace saying a transparent 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 sometimes discovered on immunological cells current within the eye. ChemR23 performs an necessary function within the inflammatory response, and binding of OK-101 to ChemR23 has been proven to provide anti-inflammatory exercise in mouse fashions of DED. OK-101 was developed utilizing a membrane-anchored-peptide (MAP) expertise to provide a novel long-acting drug candidate for treating DED. OK-101 can also be designed to fight washout by way of the inclusion of a lipid ‘anchor’ inside its molecular construction to reinforce residence time of OK-101 inside the ocular surroundings.

The one who organized for the discharge of this announcement on behalf of the Firm was Gary S. Jacob, Ph.D., Chief Govt 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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About OKYO

OKYO Pharma Restricted (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology firm admitted to itemizing on the usual phase of the Official Listing of the UK Monetary Conduct Authority and to buying and selling on the primary marketplace for listed securities of London Inventory Change plc. OKYO is specializing in the invention and improvement of novel molecules to deal with inflammatory dry eye illnesses and continual ache.

About Dry Eye Illness (DED)

Dry eye is a multifactorial illness that ends in ocular discomfort and tear movie instability that may result in ocular floor injury. It’s usually a continual drawback, significantly in older adults, and is predicted to change into much more prevalent with the ageing inhabitants and elevated use of digital screens similar to computer systems and sensible telephones. Regardless of new product approvals, dry eye illness (DED) stays a major unmet medical want and is without doubt one of the main causes for affected person visits to eye care specialists. Novel therapies that enhance the indicators and signs of dry eye illness might be helpful to dry eye sufferers.

About Ora®, Inc.

Ora is an ophthalmology analysis organisation with over 40+ years of medical and R&D expertise. We’re honored to have participated in quite a few world initiatives and in doing so, have helped prospects convey many novel merchandise to marketplace for sufferers in want. Ora is ready to present a full suite of companies for medicine and units, together with CMC, pre-clinical, medical, regulatory and publish advertising help throughout all ophthalmic therapeutic areas. We try to ship high-quality and customised medical trial companies with the additional benefit of in-house specialties, experience, and direct entry to thought-leaders and novel endpoints which can be distinctive to ophthalmology and Ora.

Sure statements made on this announcement are forward-looking statements. These forward-looking statements usually are not historic details however moderately are primarily based on the Firm’s present expectations, estimates, and projections about its business; its beliefs; and assumptions. Phrases similar to ‘anticipates,’ ‘expects,’ ‘intends,’ ‘plans,’ ‘believes,’ ‘seeks,’ ‘estimates,’ and related expressions are supposed to determine forward-looking statements. These statements usually are not ensures of future efficiency and are topic to recognized and unknown dangers, uncertainties, and different elements, a few of that are past the Firm’s management, are troublesome to foretell, and will trigger precise outcomes to vary materially from these expressed or forecasted within the forward-looking statements. The Firm cautions safety holders and potential safety holders to not place undue reliance on these forward-looking statements, which mirror the view of the Firm solely as of the date of this announcement. The forward-looking statements made on this announcement relate solely to occasions as of the date on which the statements are made. The Firm is not going to undertake any obligation to launch publicly any revisions or updates to those forward-looking statements to mirror occasions, circumstances, or unanticipated occasions occurring after the date of this announcement besides as required by regulation or by any applicable regulatory authority.

For additional info, please go to the Firm’s web site at www.okyopharma.com.

Supply: OKYO Pharma LTD