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
September
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
September 8, 2023, OKYO Pharma LTD (the “Company”) issued this 6K announcing, that it has completed full enrollment
of patients in the randomized portion of the Phase 2 multi-center, double-masked, placebo-controlled clinical trial of topical ocular
OK-101 to treat DED. A total of 240 patients have been enrolled in the study.., 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:
September 8, 2023 |
By: |
/s/
Keeren Shah |
|
Name: |
Keeren
Shah |
|
Title: |
Chief
Financial Officer |
EXHIBIT
INDEX
Exhibit
99.1
OKYO
Pharma Completes Enrollment in Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease
|
● |
Full
enrollment achieved on September 6th with a total of 240 patients enrolled in study |
|
● |
Top-line
data planned for release in December 2023 |
|
● |
Phase
2 trial is designed as a potential registration trial, with pre-specified primary efficacy endpoints covering both a sign and symptom
of dry eye disease |
London
and New York, NY, September 8, 2023 — OKYO Pharma Limited (NASDAQ: OKYO), a clinical stage biopharmaceutical company developing
innovative therapies for the treatment of inflammatory dry eye disease (“DED), a multi-billion-dollar market, and for neuropathic
corneal pain (“NCP”), a severe ocular condition with no FDA approved therapy, is pleased to announce that it has completed
full enrollment of patients in the randomized portion of the Phase 2 multi-center, double-masked, placebo-controlled clinical trial of
topical ocular OK-101 to treat DED. A total of 240 patients have been enrolled in the study.
“This
trial began in May of this year, and we have been pleased with the rapid pace of enrollment in the trial which has been managed by our
clinical development partner Ora Inc., a world leader in dry eye clinical research,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma.
“We now have 240 patients enrolled in the trial and are anticipating the last-patient last-visit to occur in the last week of November
2023, with the planned release of top-line data occurring in December 2023.”
“The
Phase 2 clinical trial is a crucial step in the development of OK-101, evaluating its safety, efficacy, and tolerability in the population
of 240 DED patients comprising the study,” said Raj Patil, Ph.D., CSO of OKYO Pharma. “We remain committed to establishing
the potential of this drug to treat the many millions of people currently suffering from DED.”
DED
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. Several 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 a clinical stage biopharmaceutical company developing innovative therapies for the treatment of inflammatory
DED) and NCP, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development
of novel molecules to treat inflammatory DED 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 of a 40-patient trial of OK-101 to treat NCP 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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