OKYO Pharma Completes Enrollment in Phase 2 Clinical Trial of OK-101 to treat Dry Eye Disease
September 08 2023 - 7:00AM
OKYO Pharma Completes Enrollment in Phase 2 Clinical Trial of
OK-101 to treat Dry Eye Disease
OKYO Pharma Limited (NASDAQ: OKYO), a clinical stage
biopharmaceutical company developing innovative therapies for the
treatment of inflammatory dry eye disease (“DED), a
multi-billion-dollar market, and for neuropathic corneal pain
(“NCP”), a severe ocular condition with no FDA approved therapy, is
pleased to announce that it has completed full enrollment of
patients in the randomized portion of the Phase 2 multi-center,
double-masked, placebo-controlled clinical trial of topical ocular
OK-101 to treat DED. A total of 240 patients have been enrolled in
the study.
"This trial began in May of this year, and we have been pleased
with the rapid pace of enrollment in the trial which has been
managed by our clinical development partner Ora Inc., a world
leader in dry eye clinical research,” said Gary S. Jacob, Ph.D.,
CEO of OKYO Pharma. “We now have 240 patients enrolled in the trial
and are anticipating the last-patient last-visit to occur in the
last week of November 2023, with the planned release of top-line
data occurring in December 2023.”
“The Phase 2 clinical trial is a crucial step in the development
of OK-101, evaluating its safety, efficacy, and tolerability in the
population of 240 DED patients comprising the study,” said Raj
Patil, Ph.D., CSO of OKYO Pharma. “We remain committed to
establishing the potential of this drug to treat the many millions
of people currently suffering from DED."
DED 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 United States alone and has
been difficult to positively diagnose and treat due to the
multifactorial nature of the condition. Several 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 and pain.
About the Phase 2 Trial Design
This phase 2, multi-center, randomized, double–blinded,
placebo-controlled study is designed to enroll approximately 240
subjects with DED who are being randomly divided into 3 cohorts of
80 patients. Participants are being selected based on specific
inclusion and exclusion criteria. The three cohorts include 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, respectively, are being administered in both eyes twice
daily for 12 weeks. The duration of a patient’s treatment is
approximately 14 weeks, including a 2-week run-in period, to
address the placebo effect, which is common for trials involving a
pain component, followed by 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 OK-101
OK-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, respectively, and is
designed to combat washout through the inclusion of the lipid
‘anchor’ contained in the drug molecule to enhance the residence
time of OK-101 within the ocular environment. OK-101 is currently
in a Phase 2, multi-center, double-masked, placebo-controlled trial
to treat dry eye disease.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage
biopharmaceutical company developing innovative therapies for the
treatment of inflammatory DED) and NCP, with ordinary shares listed
for trading on the NASDAQ Capital Market. OKYO is focused on the
discovery and development of novel molecules to treat inflammatory
DED and ocular pain. OKYO presently has a 240-patient phase 2 trial
of OK-101 underway to treat patients with DED, and also has plans
underway for the opening of a 40-patient trial of OK-101 to treat
NCP in patients with this debilitating condition. For further
information, please visit www.okyopharma.com.
About Ora, Inc.
Ora is a world-leading full-service ophthalmic drug and device
development firm with offices in the United States, United Kingdom,
Australia and Asia. For over 40 years, the company has helped
clients earn more than 50 product approvals. Ora’s pre-clinical and
clinical models, unique methodologies, and global regulatory
strategies have been refined and proven across thousands of global
projects. The company brings together the world’s most extensive
and experienced team of ophthalmic experts, R&D professionals,
and management executives to maximize the value of new product
initiatives. For more information, please
visit www.oraclinical.com, like us on Facebook, and follow us
on LinkedIn.
Forward-Looking Statements
Certain statements made in this announcement are forward-looking
statements, including with respect to the anticipated timing of
completion of enrolment of the Company’s Phase 2 trial of topical
ocular OK-101 to treat DED and the release of top-line data
therefrom. 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.comThe 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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