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6-K 1 form6-k.htm 6-K

 

 

 

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

 

April 2025

 

 

 

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 April 30, 2025, OKYO Pharma LTD (the “Company”) issued this 6K announcing today, its plans to accelerate the clinical development of urcosimod to treat NCP through the analysis of its data following the early closure of its Phase 2 trial.

 

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: April 30, 2025 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 April 30, 2025

 

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EX-99.1 2 ex99-1.htm EX-99.1

 

Exhibit 99.1

 

 

OKYO Pharma Announces Plans to Accelerate the Clinical Development of Urcosimod to Treat Neuropathic Corneal Pain

 

  Urcosimod phase 2 trial treating Neuropathic Corneal Pain (“NCP”) patients was initiated in October 2024 and designed as a double-masked, randomized, 12-week placebo-controlled trial.
  OKYO Pharma plans to analyze the efficacy data from the 17 patients who have now completed the Phase 2 trial.
  OKYO Pharma plans for a meeting with FDA following evaluation of clinical data.

 

London and New York, NY, April 30, 2025. OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company which is developing urcosimod (formerly called OK-101) to treat NCP, an ocular condition associated with chronic and often severe pain but without an FDA-approved therapy, announces plans to accelerate the clinical development of urcosimod to treat NCP through the analysis of its data following the early closure of its Phase 2 trial.

 

The Phase 2 trial of urcosimod to treat NCP was being conducted at a single trial site at Tufts Medical Center in Boston, MA. The decision to close the trial now, with 17 patients having presently completed the study, is due to OKYO’s strong desire to access the currently masked data and use it to plan its expanded development program. The patients participating in the trial have all been diagnosed with long term chronic neuropathic corneal pain and had previously been treated with multiple therapies with very limited or no response. Significant interest has been seen in the trial from long-term sufferers of NCP, and OKYO believes it should expand the development program and move forward with a multicenter trial. A considerable number of potential patients have expressed an interest in participating in a future registrational trial.

 

A number of patients who have now completed the trial have requested continued compassionate use of urcosimod which the Company is seeking to arrange with Tufts Medical Center, subject to the necessary FDA consents.

 

“By ending this trial now, we believe we can save time in advancing the program to a meeting with FDA to discuss further development of urcosimod,” commented Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. “We anticipate that the analysis of the data from these patients with the closing of this trial should take no longer than 6 weeks. Urcosimod has already demonstrated favorable safety and placebo-like tolerability in our previous 240 patient Phase 2 trial. The decision to close the trial now significantly cuts the time to our requesting an end-of-phase 2 meeting with FDA to explore accelerated plans for the drug’s further clinical development. I want to also thank our patients and study site team for their participation and commitment to this important trial of urcosimod to treat NCP.”

 

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About NCP

 

Neuropathic corneal pain is a condition that causes severe pain and sensitivity of the eyes, face, or head. The exact cause of neuropathic corneal pain is unknown but is thought to result from nerve damage to the cornea combined with inflammation. Neuropathic corneal pain, which can exhibit as a severe, chronic, debilitating condition in patients suffering from a host of ophthalmic conditions, is presently treated by various topical and systemic treatments in an off-label fashion. Notably, there is no FDA approved drug to treat this debilitating condition.

 

About the Urcosimod Phase 2 Trial in NCP Patients

 

The Phase 2 study was designed as a double-masked, randomized, 12-week placebo-controlled trial in NCP patients. A total of 48 patients were planned to enroll for the study, with NCP disease confirmed via confocal microscopy.

 

About Urcosimod (Formerly called OK-101)

 

Urcosimod 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, as well as on neurons and glial cells in the dorsal root ganglion. Urcosimod was developed using a membrane-anchored-peptide technology to produce a novel long-acting drug candidate for treating dry eye disease. Urcosimod 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 built into the drug molecule to potentially enhance the residence time of urcosimod within the ocular environment. Urcosimod showed clear statistical significance in multiple endpoints in a recently completed Phase 2, multi-center, double-masked, placebo-controlled trial to treat dry eye disease, and was also being evaluated in a randomized, placebo-controlled, double-masked Phase 2 trial to treat neuropathic corneal pain patients.

 

About OKYO

 

OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage biopharmaceutical company developing innovative therapies for the treatment of neuropathic corneal pain and dry eye disease, with ordinary shares listed for trading on the NASDAQ Capital Market. OKYO is focused on the discovery and development of novel molecules to treat neuropathic corneal pain and dry eye disease. In addition to the completed Phase 2 trial of urcosimod to treat dry eye disease patients, OKYO is also currently evaluating urcosimod to treat neuropathic corneal pain patients.

 

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

 

 

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