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OKYO Positive Sentiment Score: 75/100

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)

Key Takeaway: OKYO Pharma has activated its first clinical trial site in the U.S. for the Phase 2 trial of OK-101, aimed at treating dry eye disease. The trial is structured as a multi-center, randomized, double-blinded, placebo-controlled study, with the first patient visit expected within two weeks. OK-101 is designed to address the significant unmet need in this market, which impacts approximately 700 million people globally. The company is optimistic about enrolling patients and completing the trial by year-end, though it acknowledges the inherent risks in clinical trials.

Market Sentiment Analysis

POSITIVE FACTORS

  • First clinical trial site for Phase 2 trial activated in the U.S.
  • Potential to provide treatment for a multi-billion-dollar market.
  • OK-101 has exhibited anti-inflammatory and pain-reducing activities in mouse models.
  • Enrollment for the trial expected to begin imminently.

CONCERNS & RISKS

  • Forward-looking statements indicate uncertainty and risks regarding trial outcomes.
  • Results may differ materially from expectations due to various unpredictable factors.

Full Press Release Details

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.
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
London and New York, NY, April 25, 2023 - 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."
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.
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
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.
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

Frequently Asked Questions

What is OK-101 being developed for?

OK-101 is being developed to treat dry eye disease, addressing a significant unmet need.

When is the first patient visit for the trial expected?

The first patient visit for the trial is expected to occur within the next two weeks.

What technology was used to develop OK-101?

OK-101 was developed using membrane-anchored-peptide (MAP) technology.

How does OK-101 work in treating dry eye disease?

OK-101 acts as an antagonist of ChemR23, targeting immune cells to reduce inflammation.

What type of trial is OK-101 undergoing?

OK-101 is undergoing a phase 2, multi-center, randomized, double-blinded trial.

Last updated: Apr 25, 2023