OK-101 first-in-human Phase 2 trial will incorporate primary and secondary efficacy endpoints characterizing signs and symptoms of Dry Eye Illness

LONDON and BOSTON, Nov. 21, 2022 (GLOBE NEWSWIRE) — OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing OK-101 to treat dry eye disease to address the significant unmet need in this multi-billion-dollar market, today announced that it filed an Investigational New Drug (IND) application with the U. S. Food and Drug Administration (FDA) for the development of OK-101 in order to treat dried out eye illness (DED).

Both nonclinical plus clinical development plans on OK-101 were reviewed along with the FDA in a good earlier Pre-IND meeting facilitated by OKYO’s contract research organization, Ora Inc, with the FOOD AND DRUG ADMINISTRATION agreeing to a first-in-human Phase 2 trial in DED patients. FDA also concurred with OKYO’s plans for designating main and supplementary efficacy endpoints covering both a sign and a symptom of DED in the particular trial’s clinical protocol.

“The filing associated with this IND with FDA is a key step for OKYO as we advance our plan to open a Phase 2 test in DED patients in the first quarter of 2023, ” said Gary H. Jacob, Ph. D., CEO of OKYO Pharma. “We were pleased with the clear guidance we received from the FDA Pre-IND meeting earlier in the year. 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 particular timeline to a new drug application (NDA) filing with the FDA. ”

“FDA’s previously feedback from the Pre-IND meeting confirmed our plans for the particular first-in-human study design in order to determine the safety plus efficacy associated with OK-101 with regard to the treatment of dry eye, ” stated George Ousler, Senior Vice President regarding Ora. “Ora is looking forward to initiating the particular trial along with OKYO and evaluating this innovative therapy to potentially help millions of patients suffering from this debilitating disease. ”

“The successful filing of this IND upon OK-101 has been a central plus critical goal for the company this particular past year, ” mentioned Raj Patil, Ph. D., CSO of OKYO Pharma. “We are excited to be moving this drug into clinical trials early next year and believe that OK-101 can provide a brand new way to treat DED patients who are usually presently not well-served by currently approved drugs. ”

OK-101 is a lipid conjugated chemerin peptide agonist of the particular ChemR23 G-protein coupled receptor that is typically found on immune cells associated with the eye responsible intended for the inflammatory response. 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 within the drug molecule to enhance the residence time associated with OK-101 within the ocular environment.

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



OKYO Pharma Limited Gary T. Jacob, Ceo +44 (0)20 7495 2379
Optiva Securities Limited
Robert Emmet +44 (0)20 3981 4173
LifeSci Advisors
(Investor Relations)
Irina Koffler Irina Koffler
[email protected] com


Notes for Editors:

About OKYO

OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences company admitted to listing on NASDAQ and on the standard segment from the Official List of the UK Financial Conduct Authority and in order to trading upon the main market to get listed securities of London Stock Exchange plc. OKYO is focusing on the particular discovery plus development associated with novel molecules to deal with inflamed dry vision diseases and chronic pain. For further information, please visit www.okyopharma.com.

Regarding OK-101

OK-101 will be a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is usually available on defense cells of the attention responsible pertaining to the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate meant for treating dry eye condition. OK-101 has been demonstrated to produce anti-inflammatory plus pain-reducing actions in computer mouse models of dried out eye disease and corneal neuropathic discomfort; and it is developed to fight washout with the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the home time of OK-101 within the ocular environment.

About Timpul ® , Inc.

Ora is the world’s leading full-service ophthalmic medication and device development firm with offices in the United States, Europe, and Asia. For over 40 years, we have proudly helped our clients earn more than 50 product approvals. We support a wide array of organizations, through start-ups to global pharmaceutical and gadget companies, in order to efficiently bring their new products from concept to market. We provide together the particular world’s most extensive and experienced team of ophthalmic experts, R& D professionals, and management executives to maximize the value of new product initiatives. For more information, please visit www.oraclinical.com

About Dried out Eye Condition

Dry eye disease is a multifactorial disease that results in ocular discomfort plus tear film instability that can lead to ocular surface damage. It is often a chronic problem, particularly in older adults, and is expected to become even more prevalent with the aging population and increased use associated with digital screens such as computers and smart phones. Despite cool product approvals, dry eyes disease remains a significant unmet medical need and is one of the leading causes for patient visits in order to eye care specialists. Novel therapies that will improve the indicators and signs and symptoms of dry eye disease will be beneficial to dried out eye individuals.

Forward-Looking Statements

Certain statements made within this announcement are forward-looking statements. These forward-looking statements are not historical facts but rather are based on the Company’s current expectations, estimates, and projections about its industry; its beliefs; and assumptions. Words such as ‘anticipates, ‘ ‘expects, ‘ ‘intends, ‘ ‘plans, ‘ ‘believes, ‘ ‘seeks, ‘ ‘estimates, ‘ plus similar expressions are intended to identify forward-looking statements. These types of statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, plus other factors, some of which are usually beyond the Company’s control, are difficult in order to predict, and could cause actual results to differ materially from those expressed or forecasted within the forward-looking claims. The Company cautions security holders plus prospective protection holders not really to place undue reliance on these forward-looking statements, which reflect the view of the particular Company only as of the date associated with this announcement. The forward-looking statements made in this statement relate only to events since the date on which the statements are made. The particular Company will not undertake any obligation to release publicly any kind of revisions or even updates to these forward-looking claims to reveal events, circumstances, or unanticipated events occurring after the particular date of this announcement except as required by law or simply by any appropriate regulatory authority.

For further information, please visit you can actually website at www.okyopharma.com .

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