OKYO Pharma Announces Randomized Segment Now Underway in Phase 2 Clinical Trial of Topical Ocular OK-101 for Dry Eye Disease
06 Giugno 2023 - 3:30PM
OKYO Pharma Limited (NASDAQ: OKYO), an ophthalmology-focused
bio-pharmaceutical company which is developing OK-101 to treat dry
eye disease (DED) to address the significant unmet need in this
multi-billion-dollar market, is pleased to announce that patients
are now being dosed in the randomized portion of the phase 2,
multi-center, double-masked, placebo-controlled trial of topical
ocular OK-101 to treat DED, following the two-week placebo run-in
period intended to minimize the placebo effect.
“A two-week placebo run-in period involving topical ocular
dosing of placebo is an innovative approach used by our clinical
development partner, Ora Inc. This design feature reduces the
well-known placebo effect for ocular trials such as ours that
include an ocular discomfort readout,” said Gary S. Jacob, Ph.D.,
CEO of OKYO Pharma. “This run-in period enables us to evaluate
potential patients for the placebo effect during the run-in
screening period, improving patient selection for the randomized
treatment portion of the trial. Importantly, this first clinical
study is also designed to include two pre-specified primary
efficacy endpoints which are the hallmark of phase 3 registration
trials, and one of the efficacy endpoints deals specifically with
ocular discomfort.”
Dry eye disease is a common condition that occurs when one’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 0.05% OK-101, and the
third cohort receiving 0.1% 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 or
https://clinicaltrials.gov/ct2/results?term=Okyo&cond=Dry+Eye+Syndromes).
About OKYOOKYO Pharma Limited (NASDAQ: OKYO) is
a life sciences company admitted to listing on the NASDAQ capital
market. 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 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 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 |
U.S. 917-497-7560 |
Investor
Relations |
Paul Spencer |
+44 (0)20 7495 2379 |
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