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6-K 1 form6-k.htm

 

 

 

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

 

March 2024

 

 

 

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 March 20, 2024, OKYO Pharma LTD (the “Company”) issued this 6K announcing, that it will be releasing new and comprehensive efficacy data readout from the Phase 2 trial of OK-101 in dry eye disease on March 22, 2024. The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.

 

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.

 

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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: March 20, 2024 By: /s/ Keeren Shah
  Name: Keeren Shah
  Title: Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   News Announcement, dated March 20, 2024

 

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EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

OKYO Pharma to Release New and Comprehensive Data from Phase 2 Dry Eye Disease Trial and Host Key Opinion Leader Event

 

-Phase 2 OK-101 efficacy data to be released March 22, 2024-

 

London and New York, NY, March 20, 2024 – OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), amulti-billion-dollar market, and anterior ocular segment diseases including neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, announces that it will be releasing new and comprehensive efficacy data readout from the Phase 2 trial of OK-101 in dry eye disease on March 22, 2024. The company will also host a Key Opinion Leader (KOL) event to discuss the findings in depth.

 

In a previous preliminary data readout, OK-101 showed statistically significant drug effects in FDA-recognized efficacy endpoints as early as the 15-day first visit after dosing. Additionally, statistically significant improvements were observed in both a “sign” (total conjunctival staining) and two “symptoms” (burning/stinging and blurred vision), which are FDA-recognized endpoints of dry eye disease.

 

The KOL call will feature prominent experts in the field of dry eye disease. The speakers will provide insights regarding the clinical significance of the OK-101 Phase 2 findings and discuss the potential implications for patient care and future research endeavors in DED.

 

“The upcoming data release follows the successful completion of OKYO Pharma’s Phase 2 trial, which focused on assessing the efficacy and safety of OK-101, our novel topical therapeutic candidate for dry eye disease,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma. “We plan to advance OK-101 into Phase 3 clinical trials in 2024, with the goal of developing a highly differentiated dry eye product to help patients underserved by current treatments. Our parallel development focus for OK-101 in 2024 is the evaluation of this drug candidate to treat neuropathic corneal pain for which we have already received IND clearance to begin clinical studies.”

 

OK-101 Phase 2 Trial in DED Patients

 

The double-masked, randomized, placebo-controlled Phase 2 trial was conducted at six sites in the U.S. and enrolled 240 subjects with DED dosed twice-daily (BID). Patients were randomly divided into 3 cohorts, with one of the cohorts dosed with 0.05% OK-101 (n=81), a second with 0.1% OK-101 (n=80), and the third cohort with vehicle (n=79). The duration of a patient’s treatment was 14 weeks, including a 2-week run-in period on placebo, to exclude placebo responders from the study, followed by 12 weeks in the randomized portion of the study.

 

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 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 efficacy signals in mouse models of dry eye disease and corneal neuropathic pain (NCP), respectively, and is designed to combat washout through the inclusion of the lipid anchor built into the drug molecule to enhance the residence time of OK-101 within the ocular environment. OK-101 recently showed statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-blind, placebo-controlled trial of OK-101 to treat DED.

 

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About OKYO

 

OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of 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. In addition to the recently completed Phase 2 DED trial, OKYO also has plans underway for the opening of a Phase 2 trial for OK-101 to treat NCP in patients with this debilitating condition. For further information, please visit www.okyopharma.com.

 

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.

 

Enquiries:

 

OKYO Pharma Limited Gary S. Jacob, Chief Executive Officer 917-497-7560
Business Development & Investor Relations Paul Spencer

+44 (0)20 7495 2379

 

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