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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 29, 2024, OKYO Pharma LTD (the “Company”) issued this 6K announcing, its interim results for the six months ended 30 September 2023.

 

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 29, 2024 By: /s/ Keeren Shah
  Name: Keeren Shah
  Title: Chief Financial Officer

 

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EXHIBIT INDEX

 

Exhibit No.   Description
     
99.1   Interim Results, dated March 29, 2024

 

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EX-99.1 2 ex99-1.htm

 

Exhibit 99.1

 

 

London and New York, NY, March 29, 2024 – OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage biopharmaceutical company developing innovative ocular therapies for the treatment of inflammatory dry eye disease (DED), a multi-billion-dollar market, and for neuropathic corneal pain (NCP), an ocular condition associated with pain but without an FDA approved therapy, today announces its interim results for the six months ended 30 September 2023.

 

Clinical Updates:

 

OK-101

 

During the past six months the Group’s primary focus has been centered on completing the Phase 2 trial of OK-101 to treat DED and on analyzing its results, as well as advancing OK-101 towards a corneal neuropathic pain indication.

 

During and post this period, the Group accomplished the following:

 

Completed the Phase 2 trial of OK-101 in 240 dry eye disease patients according to projected timelines
Reported positive top line data for the Phase 2 DED trial in January 2024
Received IND clearance from the U.S. Food and Drug Administration (FDA) to test OK-101 in patients with neuropathic corneal pain.
Reported positive new findings from its Phase 2 trial of OK-101 in dry eye disease patients including a statistically significant and durable reduction in ocular pain and a statistically significant improvement in Tear Film Break-Up Time (TFBUT) throughout the study in patients receiving the 0.05% dose of OK-101. Multiple symptomatic improvements were also observed by during patient clinic visits as well as collected from patient daily symptom diaries for patients receiving the 0.05% dose.

 

The OK-101 first-in-human Phase 2 trial established a clear clinical path for further clinical development in a Phase 3 study design using FDA recognized endpoints. OK-101 demonstrated statistically significant benefit in the sign endpoint of total conjunctival staining as measured by the Ora Calibra© Staining Scale as early as Day 29 (p = 0.034). OK-101 also improved at least two symptoms of DED including burning measured by the Ora Calibra© 4-symptom questionnaire as well as burning/stinging measured by a visual analogue scale as early as Day 15 (p = 0.04 and p=0.03, respectively). A statistically significant improvement in blurred vision was also achieved at Day 29 (p = 0.01).

 

Data analyses also showed statistically significant improvement in ocular pain measured by VAS that was durable throughout the trial with p values = 0.03, 0.04 and 0.01 at Days 29, 57 and 85, respectively. Furthermore, OK-101 improved TFBUT as early as Day 15 and the improvement lasted throughout the trial with p values = 0.01, 0.05, 0.02, and 0.03 at Days 15, 29, 57 and 85, respectively. Additionally, data obtained from daily symptom diaries maintained by patients during the trial, commonly referred to as patient-reported outcome data, confirmed several of the DED symptoms also measured in the clinic, exhibiting significant improvements as early as Day 1 through Day 15 for pain, burning/stinging, eye dryness and itching, with p values of 0.01, 0.06, 0.005 and 0.009, respectively.

 

Treatment emergent adverse events (TEAEs) were observed to be similar to the placebo-treated group. No severe drug related ocular TEAEs were seen. Possible drug-related TEAEs were observed in one patient in the OK-101 0.05% treatment group and 3 patients in the placebo-treated group, again highlighting the favourable safety profile of OK-101.

 

OKYO plans to engage with the FDA on next steps forward with an End-of-Phase 2 meeting with the Agency, and is planning to begin the Phase 3 trial of OK-101 in DED by the end of 2024..

 

 

 

In February 2024, the Company announced that it was the first company that had received Investigational New Drug Application (IND) clearance to study OK-101 in neuropathic corneal pain (NCP). The Company plans to initiate a Phase 2 trial in NCP in 2024.

 

The Phase 2 study is designed as a double-masked, randomized, 12-week placebo-controlled trial comparing OK-101 to placebo in NCP patients. A total of 54 patients are planned for the study, with NCP disease confirmed via confocal microscopy. The primary endpoint will be measured utilizing VAS pain relief scores. The OK-101 trial, designed as a single-center trial, will be led by Pedram Hamrah, MD, of Tufts Medical Center, as Principal Investigator. Dr. Hamrah is Professor and Vice Chair of Research and Academic Programs, Co-Director of the Cornea Service and Director of the Center for Translational Ocular Immunology at Tufts Medical Center.

 

Financial Highlights:

 

Total assets of £1.9 million (31 March 2023: £4.2 million)
Cash on hand of £1.3 million (31 March 2023: £3.3 million)
During the financial period under review, the Company reported a total comprehensive loss of £7.0million (compared to total comprehensive loss of £4.6 million for the six months ending September 30 2022)

 

OKYO’s interim results can be accessed by visiting the investors section of the company’s website at https://okyopharma.com/investors/corporate-governance/corporate-documents

 

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.

 

Enquiries:

 

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

+44 (0)20 7495 2379