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("OKYO" or the "Company") - OKYO Pharma Announces Positive Data and Results in an Animal Model using Topically Administered OK-201 to Treat Neuropathic Ocular Pain

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OKYO Pharma Limited (OTCQB: EMMLF) announced positive preclinical results for OK-201, a non-opioid analgesic drug candidate, in a mouse model for neuropathic corneal pain. The collaboration with Dr. Pedram Hamrah at Tufts Medical Center showed that OK-201 reduced corneal pain response akin to gabapentin, marking it as a potential treatment option. With no current FDA-approved medications for ocular pain, the findings could significantly impact patient care. Additionally, the company is progressing with OK-101, targeting inflammatory pathways for dry eye syndrome, with IND submission expected in 2022.

Positive
  • OK-201 shows potential as a non-opioid analgesic for treating corneal pain, demonstrated by preclinical proof-of-concept.
  • Research collaboration with Dr. Pedram Hamrah enhances credibility and research validity.
  • No FDA-approved treatments currently available for ocular pain, indicating a significant market opportunity.
Negative
  • Relying on preclinical results, which are not guaranteed to translate to human efficacy or safety.
  • The timeline for IND submission for OK-101 is set for 2022, which means potential delays in product availability.

LONDON and BOSTON, April 28, 2021 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF), a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, is pleased to announce positive results of OK-201, a non-opioid analgesic drug candidate, delivered topically in a mouse neuropathic corneal pain model demonstrating its potential to treat acute and chronic ocular pain. The research program involved a key collaboration with Pedram Hamrah, MD, an ophthalmologist, cornea specialist, and Clinician-Scientist at Tufts Medical Center and Professor of Ophthalmology at Tufts University School of Medicine, Boston. The collaborative effort was focused on evaluating OKYO’s lead compounds as potential non-opioid analgesics to suppress neuropathic corneal pain using a mouse model of neuropathic corneal pain recently developed in Dr. Hamrah’s laboratory, which is based on ligation of ciliary nerves. Importantly, OK-201 demonstrated a reduced corneal pain response similar to that of gabapentin, a commonly used oral drug for neuropathic pain. These observations demonstrated preclinical ‘proof-of-concept’ for the topical administration of OK-201 as a potential non-opioid analgesic for ocular pain. Current treatments for corneal pain are limited to short term NSAIDs, steroids, and oral gabapentin and opioids in severe cases. Side effects and the risk of addiction to opioids is a serious concern.

“Neuropathic corneal pain is a severe, chronic and debilitating disease,” said Dr. Hamrah. “No commercially available treatments are currently available for this condition, so we are excited about these positive results in our pre-clinical model of this disease.”

“In addition to the ocular pain analgesic program, OKYO is also pursuing development of our lead drug candidate, OK-101, a lipidated chemerin receptor agonist that targets inflammatory pathways to treat dry eye syndrome, uveitis and allergic conjunctivitis,” said Dr. Gary S. Jacob, CEO of OKYO. “IND-enabling studies for OK-101 are currently underway, and we anticipate IND submission for dry eye indication in 2022.”

About OK-201

OK-201, a lipidated cyclized bovine adrenal medulla (“BAM8”) analogue, a promising candidate for the treatment of neuropathic and inflammatory pain, was licensed from Tuffs University on February 21, 2018. OK-201 is designed to activate a human MAS-related G protein-coupled receptor, or MRGPR, which is a promising analgesic target. This receptor is expressed mainly in sensory neurons and is involved in the perception of pain. Activation of MRGPR by BAM8 peptides inhibits pain by modulating Ca2+ influx.

About Ocular Pain

Ocular pain is one of the most common causes for patient referral to the emergency clinic, with substantial implications to global quality of life and healthcare cost. Millions of people suffer from ocular pain every year with no FDA approved treatment for this condition. Side effects and the risk of addiction to opioids is a serious concern. Ocular pain may arise directly from tissue damage at the ocular surface after surgery, injury, infection or from changes to peripheral or central nerves in the ocular surface. Ocular neuropathic pain refers to the increased perception of pain in response to ordinarily non-painful stimuli and is often misdiagnosed as dry eye disease. Current treatments are limited to short term NSAIDs, steroids, and oral gabapentin and opioids in severe cases.

The person who arranged for the release of this announcement on behalf of the Company was Dr. Gary S. Jacob, Chief Executive Officer of OKYO.

Enquiries:

OKYO Pharma LimitedGary S. Jacob, Chief Executive Officer

Gabriele Cerrone, Non-Executive Chairman
+44 (0)20 7495 2379
   
Optiva Securities Limited
(Broker)
Robert Emmet+44 (0)20 3981 4173
   
RedChip Companies Inc.
(Investor Relations)
Dave Gentrydave@redchip.com

+1 407-491-4498

Notes for Editors:

About OKYO

OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF) is a life sciences and biotechnology company admitted to listing on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities of London Stock Exchange plc. OKYO is focusing on the discovery and development of novel molecules to treat inflammatory dry eye diseases and chronic pain.

Forward-Looking Statements:

Certain statements made in this announcement are forward-looking statements. 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.

NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, IN OR INTO OR FROM ANY JURISDICTION WHERE TO DO SO WOULD CONSTITUTE A VIOLATION OF THE RELEVANT LAWS OF SUCH JURISDICTION

THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU (WHICH FORMS PART OF DOMESTIC UK LAW PURSUANT TO THE EUROPEAN UNION (WITHDRAWAL) ACT 2018) ("UK MAR"). UPON THE PUBLICATION OF THIS ANNOUNCEMENT, THIS INSIDE INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN. THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION (EU) NO 596/2014OKYO Pharma Limited


FAQ

What are the results of OKYO Pharma's OK-201 drug candidate for ocular pain?

OK-201 demonstrated a reduced corneal pain response in a mouse model, showing potential as a non-opioid analgesic.

What is the significance of the collaboration with Dr. Pedram Hamrah regarding OK-201?

The collaboration underscores the credibility of the research and its relevance to treating neuropathic corneal pain.

When does OKYO Pharma plan to submit the IND for OK-101?

The IND submission for OK-101 is anticipated in 2022, targeting inflammatory dry eye syndrome.

What current treatments exist for ocular pain?

Current treatments are limited to NSAIDs, steroids, and oral medications like gabapentin and opioids.

What is the stock symbol for OKYO Pharma?

The stock symbol for OKYO Pharma is EMMLF, trading on the OTCQB.

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