OKYO Pharma Announces US IND Filing for OK-101 for the Treatment of Dry Eye Disease
First-in-man Phase 2 OK-101 trial will incorporate primary and secondary efficacy endpoints characterizing signs and symptoms of dry eye disease
LONDON and BOSTON, Nov. 21, 2022 (GLOBE NEWSWIRE) — OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO), an ophthalmology-focused biopharmaceutical company developing OK-101 to treat dry eye to address the significant unmet need in this multi-billion dollar market, has announced today that it has filed an Investigational New Drug (IND) Application with the United States Food and Drug Administration (FDA) for the development of OK-101 to treat dry eye disease (DED) .
Non-clinical and clinical development plans for OK-101 were reviewed with the FDA at a previous pre-IND meeting facilitated by OKYO’s contract research organization, Ora Inc, with the FDA agreeing to a first-in-man phase 2 trial in DED patients. The FDA also approved OKYO’s plans to designate primary and secondary efficacy endpoints covering both a sign and a symptom of DED in the clinical protocol for the trial.
“The filing of this IND with the FDA is a key milestone for OKYO as we move forward with our plan to initiate a Phase 2 trial in DED patients in the first quarter of 2023,” said Gary S. Jacob, Ph.D., CEO of OKYO. Pharmacy. “We were pleased with the clear guidance we received from the FDA pre-IND meeting earlier in the year. The fact that we are designating primary and secondary efficacy endpoints in this first-in-man trial is very important, because if our next OK-101 trial meets its predefined primary endpoint, it could accelerate the timeline for a New Drug Application (NDA) filing with the FDA.
“FDA’s earlier comments on the pre-IND meeting confirmed our plans for the first-in-man study design to determine the safety and efficacy of OK-101 for the treatment of dryness. eye,” said George Ousler, senior vice president of Ora. “Ora is excited to initiate the trial with OKYO and evaluate this innovative therapy to potentially help millions of patients suffering from this debilitating disease.”
“The successful filing of this IND on OK-101 has been a central and critical goal for the company over the past year,” said Raj Patil, Ph.D., CSO of OKYO Pharma. “We are excited to move this drug into clinical trials early next year and believe OK-101 can provide a new way to treat DED patients who are currently not well served by currently approved drugs. “
OK-101 is a chemerin peptide agonist conjugated to a lipid of the G protein-coupled receptor ChemR23 that is typically found on the 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 improve the residence time of OK-101 in the ocular environment.
The person who arranged for the publication of this announcement on behalf of the company was Gary S. Jacob, Ph.D., President and CEO of OKYO.
THIS ANNOUNCEMENT CONTAINS ORIGINAL INFORMATION FOR THE PURPOSES OF ARTICLE 7 OF REGULATION 2014/596/EU WHICH IS PART OF UK NATIONAL LAW PURSUANT TO THE MARKET ABUSE (AMENDMENT) (EXITING THE EU) REGULATIONS (SI 2019/ 310) (“UK MAR”) . AT THE PUBLISHING OF THIS ANNOUNCEMENT, THIS INITIAL INFORMATION (AS DEFINED IN UK MAR) IS NOW CONSIDERED TO BE IN THE PUBLIC DOMAIN.
|OKYO Pharma Limited||Gary S. Jacob, General Manager||+44 (0)20 7495 2379|
|Optiva Securities Limited
|Robert Emmet||+44 (0)20 3981 4173|
|Irina Köffler||Irina Köffler
Notes for editors:
OKYO Pharma Limited (LSE: OKYO; NASDAQ: OKYO) is a life sciences company admitted to listing on NASDAQ and the Standard Segment of the UK Financial Conduct Authority’s Official List and trading on the Main Market of listed securities of London Stock Exchange plc. OKYO focuses on the discovery and development of new molecules to treat inflammatory dry eye disease and chronic pain. For more information, visit www.okyopharma.com.
OK-101 is a lipid-conjugated chemerin peptide antagonist of the G protein-coupled receptor ChemR23 that is typically found on the immune cells of the eye responsible for the inflammatory response. OK-101 was developed using membrane-anchored peptide (MAP) technology to produce a novel long-acting drug candidate for the treatment of dry eye disease. OK-101 has been shown to produce anti-inflammatory and pain-relieving activities in mouse models of dry eye and corneal neuropathic pain; and is designed to combat washout through the inclusion of the lipid “anchor” contained within the candidate drug molecule to improve the residence time of OK-101 in the ocular environment.
Ora is the world’s leading full-service ophthalmic drug and device development company with offices in the United States, Europe and Asia. For over 40 years, we’ve proudly helped our customers achieve over 50 product approvals. We support a wide range of organizations, from start-ups to global pharmaceutical and device companies, to effectively bring their new products from concept to market. We bring together the world’s largest and most experienced team of ophthalmology experts, R&D professionals and senior executives to maximize the value of new product initiatives. For more information, visit www.oraclinical.com
About dry eye
Dry eye is a multifactorial disease that causes ocular discomfort and tear film instability that can lead to ocular surface damage. It is often a chronic problem, especially in older people, and is expected to become even more prevalent with an aging population and increased use of digital screens such as computers and smart phones. Despite new product approvals, dry eye remains a significant unmet medical need and is a leading cause of patient visits to eye care specialists. New therapies that improve the signs and symptoms of dry eye disease will benefit patients with dry eye disease.
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 regarding its industry; his 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 control of the Company, are difficult to predict and could cause actual results differ materially from those expressed or anticipated. in forward-looking statements. The Company cautions securityholders and potential securityholders not to place undue reliance on these forward-looking statements, which reflect the Company’s views only as of the date of this announcement. Forward-looking statements made in this announcement relate only to events as of the date the statements are made. The Company undertakes no obligation to publicly release revisions or updates to these forward-looking statements to reflect unforeseen events, circumstances or developments occurring after the date of this announcement, except as required by law or any applicable regulatory authority. ‘required.
For more information, please visit the Company’s website at www.okyopharma.com.