OKYO Pharma Announces U.S. FDA Clearance of IND Application for OK-101 for the Treatment of Dry Eye Disease
OKYO Pharma Limited has received FDA clearance to start a Phase 2 clinical trial for OK-101, a treatment for Dry Eye Disease (DED). This first-in-human study will assess both efficacy endpoints relating to the signs and symptoms of DED. The trial is set to begin in Q1 2023, aiming to demonstrate OK-101's potential as a novel treatment option for patients inadequately addressed by existing medications. The company emphasizes that success in this trial could expedite the filing for a new drug application (NDA) with the FDA.
- FDA clearance received for Phase 2 trial of OK-101.
- Trial focuses on signs and symptoms of Dry Eye Disease, addressing unmet medical needs.
- Potential expedited NDA filing if Phase 2 trial meets primary endpoint.
- None.
-OK-101 first-in-human Phase 2 trial will incorporate primary and secondary efficacy endpoints characterizing signs and symptoms of Dry Eye Disease-
-Phase 2 study expected to open to enrollment in the first quarter 2023-
LONDON and NEW YORK, Dec. 22, 2022 (GLOBE NEWSWIRE) -- OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical company developing OK-101 to treat dry eye disease (DED) to address the significant unmet need in this multi-billion-dollar market, today announced that it has received clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 2, first-in-human, clinical study of OK-101 for the treatment of DED. The FDA previously concurred with OKYO’s plans for designating primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the clinical study protocol.
“We are very pleased to receive clearance from the FDA to initiate our OK-101 Phase 2 study,” said Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma. “We believe this first-in-human study will help demonstrate that OK-101 may provide a new way to treat DED patients who are not well-served by currently approved drugs. Based on earlier feedback from the FDA we are designating primary and secondary efficacy endpoints in this study that include both a sign and a symptom of the disease. Should our Phase 2 study meet its prespecified primary endpoint, it may accelerate the timeline to a new drug application (NDA) filing for OK-101 with the FDA. The clearance of our IND for OK-101 has been a key priority for the company this past year, and we are excited to be moving this drug into the clinic in the first quarter of 2023.”
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 has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED 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.
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.
THIS ANNOUNCEMENT CONTAINS INSIDE INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF DOMESTIC UK LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EU EXIT) REGULATIONS (SI 2019/310) ("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.
Enquiries:
| OKYO Pharma Limited | Gary S. Jacob, Chief Executive Officer | +44 (0)20 7495 2379 |
| Optiva Securities Limited (Broker) | Robert Emmet | +44 (0)20 3981 4173 |
| LifeSci Advisors (Investor Relations) | Irina Koffler | Irina Koffler ikoffler@lifesciadvisors.com +1-917-734-7387 |
Notes for Editors:
About OKYO
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences company admitted to listing on NASDAQ and 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. For further information, please visit www.okyopharma.com.
About OK-101
OK-101 is a lipid conjugated chemerin peptide antagonist 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; and is designed to combat washout through the inclusion of the lipid ‘anchor’ contained in the candidate drug molecule to enhance the residence time of OK-101 within the ocular environment.
About Dry Eye Disease
Dry eye disease is a multifactorial disease that results in ocular discomfort and tear film instability that can lead to ocular surface damage. It is often a chronic problem, particularly in older adults, and is expected to become even more prevalent with the aging population and increased use of digital screens such as computers and smart phones. Despite new product approvals, dry eye disease remains a significant unmet medical need and is one of the leading causes for patient visits to eye care specialists. Novel therapies that improve the signs and symptoms of dry eye disease will be beneficial to dry eye patients.
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.
FAQ
What is the significance of OKYO receiving FDA clearance for OK-101?
When is the Phase 2 trial for OK-101 expected to begin?
What are the primary endpoints of the OK-101 clinical study?
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What is Dry Eye Disease and why is it a concern?
