OKYO Pharma
Completes Enrollment
in
Phase 2 Clinical Trial of OK-101 to treat Dry Eye
Disease
-
Full
enrollment achieved on September 6th
with a total
of 240 patients enrolled in study
-
Top-line
data planned for release in December 2023
-
Phase 2
trial is designed as a potential registration trial, with
pre-specified primary efficacy endpoints covering both a sign and
symptom of DED
London and New York, NY, September
8, 2023 -- InvestorsHub NewsWire -- 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.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
|