OKYO Pharma Announces First-Patient First-Visit for Phase 2 Trial Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye Disease
02 5월 2023 - 3:00PM
OKYO Pharma Announces First-Patient First-Visit for Phase 2 Trial
Evaluating Efficacy and Safety of OK-101 in Patients with Dry Eye
Disease
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 DesignThis 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 OKYOOKYO 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-101OK-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 StatementsCertain 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:
OKYO Pharma Limited |
Gary S. Jacob, Chief Executive Officer |
+44 (0)20 7495 2379 |
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Investor
Relations |
Paul Spencer |
+44 (0)20 7495 2379 |
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Optiva Securities
Limited(Broker) |
Robert Emmet |
+44 (0)20 3981 4173 |
Okyo Pharma (LSE:OKYO)
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