TIDMOKYO
RNS Number : 9844X
OKYO Pharma Limited
02 May 2023
OKYO Pharma Announces First-Patient First-Visit for Phase 2
Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry
Eye Disease
-- Trial designed with pre-specified primary efficacy endpoints discussed previously with FDA
-- If successful, this phase 2 trial may serve as one of the two
required phase 3 studies necessary to support FDA approval
-- Top-line data from trial anticipated before end of 2023
London and New York, NY, May 2, 2023 - OKYO Pharma Limited (LSE:
OKYO; NASDAQ: OKYO), an ophthalmology-focused bio-pharmaceutical
company which is developing OK-101 to treat dry eye disease to
address the significant unmet need in this multi-billion-dollar
market, is pleased to announce that the first patient has been
screened for its phase 2, multi-center, randomized, double-blinded,
placebo-controlled trial, evaluating the efficacy and safety of
OK-101 ophthalmic solution in subjects with dry eye disease
(DED).
"The initiation of this trial of topically applied OK-101 to
treat dry eye disease marks a significant step for the company as
we have been laser focused on moving this drug candidate into
clinical trials over the last 18 months," said Gary S. Jacob,
Ph.D., CEO of OKYO Pharma. "Importantly, this first clinical study
is designed to include pre-specified primary efficacy endpoints
which are the hallmark of phase 3 registration trials, and the
results from this trial are anticipated before the end of this
year. The drug has been shown in pre-clinical studies to have
potent anti-inflammatory and neuropathic corneal pain activities,
and we are eager to evaluate its potential benefits in the
clinic."
"One of the most exciting aspects of this innovative clinical
program is that we can get a rapid and informative answer on both
safety and efficacy of OK-101 by the end of the year," said
Gabriele Cerrone, Executive Chairman and Founder of OKYO Pharma.
"Furthermore, positive results would allow us to expedite the
program towards FDA approval by leveraging results from this phase
2 dry eye trial in lieu of one of the two required phase 3 trials
needed to support U.S. marketing authorization. OKYO remains
well-positioned as novel ophthalmic compounds in large markets
represent promising acquisition targets as evidenced by the recent
$5.9 billion Iveric deal."
Dry eye disease is a common condition that occurs when an
individual's tears are unable to adequately lubricate the eyes.
This condition affects approximately 49 million people in the U.S.
alone and has been a difficult one to positively diagnose and to
treat due to the multifactorial nature of the condition. A number
of contributing factors can lead to this condition, including age,
sex, certain medical conditions, reduced tear production and tear
film dysfunction. Tear film instability typically leads to
inflammation and damage to the ocular surface.
About the Phase 2 Trial Design
This phase 2, multi-center, randomized, double-blinded,
placebo-controlled study is planned to enroll approximately 240
subjects with DED who will be randomly divided into 3 cohorts of 80
patients. Participants will be selected based on specific inclusion
and exclusion criteria. The three cohorts will be comprised of one
cohort treated with placebo, a second cohort treated with a low
dose of OK-101, and the third cohort receiving a higher dose of
OK-101. The drug and placebo will be administered in both eyes
twice daily for 12 weeks. The duration of a patient's treatment
will be approximately 14 weeks, including a 2-week run-in period
and 12 weeks of treatment. The protocol for the study includes two
prespecified primary endpoints and a number of secondary endpoints.
Further details regarding the specifics of the trial are posted on
the ClinicalTrials.gov public website (ClinicalTrials.gov
Identifier: NCT05759208).
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.
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
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:
Gary S. Jacob, Chief Executive +44 (0)20 7495
OKYO Pharma Limited Officer 2379
+44 (0)20 7495
Investor Relations Paul Spencer 2379
Optiva Securities
Limited +44 (0)20 3981
(Broker) Robert Emmet 4173
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