OKYO Pharma Announces Activation of First Clinical Trial Site in the U.S. for the Phase 2 Trial Evaluating OK-101 for the Treatment of Dry Eye Disease
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) has announced the activation of its first clinical trial site in the U.S. for a phase 2 study of its ophthalmic solution, OK-101, aimed at treating dry eye disease. The trial is a multi-center, randomized, double-blinded, placebo-controlled study designed to evaluate the efficacy and safety of OK-101. The first patient visit is anticipated within two weeks. CEO Gary S. Jacob emphasized the company's commitment to advancing OK-101’s development, noting that dry eye disease affects approximately 700 million people globally. OK-101 is a novel long-acting drug candidate developed to alleviate inflammation and pain associated with dry eye conditions.
- Activation of the first clinical trial site in the U.S. for OK-101.
- First patient visit expected within two weeks.
- Focus on addressing significant unmet need in the multi-billion-dollar dry eye disease market.
- Potential treatment option for approximately 700 million people worldwide.
- None.
LONDON and NEW YORK, April 25, 2023 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO or the “Company”), 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 announces the activation of the first clinical trial site in the U.S. for its phase 2, multi-center, randomized, double-blinded, placebo-controlled trial, evaluating the efficacy and safety of OK-101 ophthalmic solution in subjects with dry eye disease. First patient first visit is presently expected to occur within the next two weeks.
“Our primary focus continues to be on advancing the clinical development of OK-101 as a potential treatment option for dry eye disease, a chronic ocular condition that affects roughly 700 million people worldwide,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “With the activation of our first clinical site we are now very close to the opening of the OK-101 phase 2 trial and are looking forward to initiating enrollment and completing the trial before the end of the year."
About OK-101
OK-101 is a lipid conjugated chemerin peptide antagonist of the ChemR23 G-protein coupled receptor which is typically found on immune cells of the eye responsible for the inflammatory response. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating dry eye disease. 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 candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.
About OKYO
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences company admitted to listing on NASDAQ and on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain. For further information, please visit www.okyopharma.com.
Forward-Looking Statements
Certain statements made in 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,' and similar expressions are intended to identify forward-looking statements. These statements are not guarantees of future performance and are subject to known and unknown risks, uncertainties, and other factors, some of which are beyond the Company's control, are difficult to predict, and could cause actual results to differ materially from those expressed or forecasted in the forward-looking statements. The Company cautions security holders and prospective security holders not to place undue reliance on these forward-looking statements, which reflect the view of the Company only as of the date of this announcement. The forward-looking statements made in this announcement relate only to events as of the date on which the statements are made. The Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances, or unanticipated events occurring after the date of this announcement except as required by law or by any appropriate regulatory authority.
For further information, please visit the Company's website at www.okyopharma.com
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.
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Ph.D., Chief Executive Officer | +44 (0)20 7495 2379 |
| Investor Relations | Paul Spencer | +44 (0)20 7495 2379 |
| Optiva Securities Limited (Broker) | Robert Emmet | +44 (0)20 3981 4173 |
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.
FAQ
What is the purpose of OKYO's phase 2 clinical trial for OK-101?
When is the first patient expected to visit for the OK-101 trial?
How many people are affected by dry eye disease globally?
What type of trial is OKYO conducting for OK-101?
What is OK-101 designed to do?
