UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
August
2023
Commission
File Number: 001-41386
OKYO
Pharma LTD
(Exact
Name of Registrant as Specified in Its Charter)
9th
Floor
107
Cheapside
London
EC2V
6DN
(Address
of registrant’s principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form
20-F ☒ Form 40-F ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate
by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INFORMATION
CONTAINED IN THIS REPORT ON FORM 6-K
On
August 30, 2023, OKYO Pharma LTD (the “Company”) issued this 6K announcing, that it has enrolled and randomized 90%
of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular OK-101 to
treat DED., a copy of which is furnished as Exhibit 99.1
The
Announcement is furnished herewith as Exhibit 99.1 to this Report on Form 6-K. The information in the attached Exhibits 99.1 is being
furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise
subject to the liabilities of that Section, nor shall it be deemed incorporated by reference in any filing made by the Company under
the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as otherwise set forth herein or as shall be expressly
set forth by specific reference in such a filing.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
|
OKYO
Pharma LTD |
|
|
|
Date:
August 30, 2023 |
By: |
/s/
Keeren Shah |
|
Name: |
Keeren
Shah |
|
Title: |
Chief
Financial Officer |
EXHIBIT
INDEX
Exhibit 99.1
OKYO
Pharma Achieves 90% Enrollment in 240-Patient Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease (“DED”)
|
● |
Full
enrollment anticipated by first week of September |
|
● |
OKYO
on schedule to release top-line data before end of 2023 |
|
● |
Phase
2 trial is designed as potential registration trial with pre-specified primary efficacy endpoints covering both a sign and symptom
of DED |
London
and New York, NY, August 30, 2023 — OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which
is developing OK-101 to treat DED to address the significant unmet need in this multi-billion-dollar market, is pleased to announce that
it has enrolled and randomized 90% of the patients in its 240-patient Phase 2 multi-center, double-masked, placebo-controlled clinical
trial of topical ocular OK-101 to treat DED.
“We
are very pleased at the rapid pace of enrollment we are seeing in our ongoing Phase 2 trial of our flagship drug OK-101 to treat patients
with DED. This trial began in May of this year, with the first patient being randomized in June into one of the three cohorts. Having
enrolled 90% of the patients in this trial is an important milestone for OKYO Pharma,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma.
“We presently have 216 patients enrolled in the trial and are anticipating completing full enrollment by the first week in September.
Moreover, the pace at which we are enrolling patients has been encouraging in moving us toward our planned release of top-line data by
end of 4Q 2023.”
“The
Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in a larger
patient population. We sincerely appreciate the clinicians and staff that are contributing to the conduct of this trial and are extremely
grateful to the patients that have chosen to participate,” said Raj Patil, Ph.D., CSO of OKYO Pharma. “The Company remains
laser focused on completing the trial, which is managed by our clinical development partner Ora Inc. a world leader in dry eye clinical
research, and is committed to establishing the potential of this drug to treat the many millions of people currently suffering from DED.”
Dry
eye disease is a common condition that occurs when one’s tears are unable to adequately lubricate the eyes. This condition affects
approximately 49 million people in the United States alone and has been difficult to positively diagnose and treat due to the multifactorial
nature of the condition. A number of contributing factors can lead to this condition, including age, sex, certain medical conditions,
reduced tear production and tear film dysfunction. Tear film instability typically leads to inflammation and damage to the ocular surface
and pain.
About
the Phase 2 Trial Design
This
phase 2, multi-center, randomized, double–blinded, placebo-controlled study is designed to enroll approximately 240
subjects with DED who are being randomly divided into 3 cohorts of 80 patients. Participants are being selected based on specific inclusion
and exclusion criteria. The three cohorts include one cohort treated with placebo, a second cohort treated with 0.05% OK-101, and the
third cohort receiving 0.1% OK-101. The drug and placebo, respectively, are being administered in both eyes twice daily for 12 weeks.
The duration of a patient’s treatment is approximately 14 weeks, including a 2-week run-in period, to address the placebo effect,
which is common for trials involving a pain component, followed by 12 weeks of treatment. The protocol for the study includes two prespecified
primary endpoints and a number of secondary endpoints. Further details regarding the specifics of the trial are posted on the clinicaltrials.gov
public website (clinicaltrials.gov Identifier: NCT05759208 or https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).
About
OK-101
OK-101
is a lipid conjugated chemerin peptide agonist 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, respectively, and is designed to combat washout through the
inclusion of the lipid ‘anchor’ contained in the drug molecule to enhance the residence time of OK-101 within the ocular
environment. OK-101 is currently in a Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease.
About
OKYO
OKYO
Pharma Limited (NASDAQ: OKYO) is an ophthalmology-focused biopharmaceutical company with ordinary shares listed for trading on the NASDAQ
Capital Market. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular
pain. OKYO presently has a 240-patient phase 2 trial of OK-101 underway to treat patients with DED, and also has plans underway for the
opening a 40-patient trial of OK-101 to treat neuropathic corneal pain in patients with this debilitating condition.For further information,
please visit www.okyopharma.com.
About
Ora, Inc.
Ora
is a world-leading full-service ophthalmic drug and device development firm with offices in the United States, United Kingdom, Australia
and Asia. For over 40 years, the company has helped clients earn more than 50 product approvals. Ora’s pre-clinical and clinical
models, unique methodologies, and global regulatory strategies have been refined and proven across thousands of global projects. The
company brings together the 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, like us on
Facebook, and follow us on LinkedIn.
Forward-Looking
Statements
Certain
statements made in this announcement are forward-looking statements, including with respect to the anticipated timing of completion of
enrolment of the Company’s Phase 2 trial of topical ocular OK-101 to treat DED and the release of top-line data therefrom. 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, Chief Executive Officer |
U.S.
917-497-7560 |
|
|
|
Investor
Relations |
Paul
Spencer |
+44
(0)20 7495 2379 |
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