IND filing Q3 2022 and Phase 2 initiation Q4 2022

RNS Number : 5974U

OKYO Pharma Limited

06 December 2021

 

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.

OKYO Pharma Limited

("OKYO" or the "Company")

OKYO to File IND in Q3 2022 for OK-101 to treat Dry Eye Disease ("DED") and to go directly to a Phase 2 Human Clinical Efficacy Trial in DED Patients with a planned start date in Q4 2022 on an accelerated basis

London, December 6, 2021 - OKYO Pharma Limited (LSE: OKYO; OTCQB: EMMLF), the biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, is pleased to announce that working with Ora, Inc., a world-class ophthalmic clinical development partner, it is currently anticipating the filing of an IND in Q3 2022 for OK-101 in the treatment of dry eye disease. OK-101, OKYO's lead pre-clinical compound is a novel long-acting, G protein-coupled receptor-based anti-inflammatory drug candidate.

OK-101 is anticipated to commence human studies with a Phase 2 clinical trial in DED patients in Q4, 2022. The trial is anticipated to be conducted in approximately 100 to 200 DED patients. The study is being designed in conjunction with, and will be managed and monitored by Ora, Inc., well known for its expert leadership of clinical trial activities. The Phase 2 trial is expected to be completed in 6-8 months from enrollment of the first patient.

"Based on the anti-inflammatory response seen in pre-clinical models, this novel mechanism of action may prove to be a breakthrough treatment for the over 700 million DED patients globally," commented George W. Ousler III, Sr. Vice President, Anterior Segment of Ora, Inc. "Ora is honored to partner with OKYO Pharma to evaluate this promising candidate, and we look forward to moving expeditiously through phase 2 as we work together to elevate the future DED standard of care."

"We recognize that news-flow from the Company has been limited over the past 9 months, however in that time we have been focused on advancing all necessary IND-enabling studies on OK-101 and are now in a position to announce that we plan to file the IND to treat DED in Q3 2022," said Gary S Jacob, Ph.D., CEO of OKYO. "Because the drug is designed to be administered topically to dry eye patients, and with the help of Ora's deeply knowledgeable team with a proven track record of advancing drug development for dry eye as well as other ophthalmic indications, we anticipate skipping standard Phase 1 studies typically expected with orally delivered drug candidates in non-life-threatening conditions and opening the first human trial with OK-101 as a Phase 2 efficacy trial in DED patients. We are accordingly delighted to be able to deliver this update announcing a clear and accelerated path into the clinic for OK-101."

OK-101 is a lipidated chemerin peptide developed to bind to ChemR23 G protein-coupled receptors typically found on immunological cells present in the eye. ChemR23 plays an important role in the inflammatory response, and binding of OK-101 to ChemR23 has been shown to produce anti-inflammatory activity in mouse models of DED. OK-101 was developed using a membrane-anchored-peptide (MAP) technology to produce a novel long-acting drug candidate for treating DED. OK-101 is also designed to combat washout through the inclusion of a lipid 'anchor' within its molecular structure to enhance 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.

Enquiries:

OKYO Pharma Limited	Gary S. Jacob, Chief Executive Officer Gabriele Cerrone, Non-Executive Chairman	[phone]
Optiva Securities Limited (Broker)	Robert Emmet	[phone]
RedChip Companies Inc. (Investor Relations)	Dave Gentry	[e-mail] [phone]

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.

About Dry Eye Disease (DED)

Dry eye 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 (DED) 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.

About Ora^®, Inc.

Ora is an ophthalmology research organisation with over 40+ years of clinical and R&D experience. We are honored to have participated in numerous global projects and in doing so, have helped customers bring many novel products to market for patients in need.  Ora is able to provide a full suite of services for drugs and devices, including CMC, pre-clinical, clinical, regulatory and post marketing support across all ophthalmic therapeutic areas. We strive to deliver high-quality and customised clinical trial services with the added benefit of in-house specialties, expertise, and direct access to thought-leaders and novel endpoints that are unique to ophthalmology and Ora.

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 .

 

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