OKYO Pharma to Host Key Opinion Leader Event to Discuss New and Comprehensive Data from Phase 2 Dry Eye Disease Trial
2024年3月21日 - 8:00PM
RNSを含む英国規制内ニュース (英語)
OKYO Pharma to Host Key Opinion Leader Event to Discuss New and
Comprehensive Data from Phase 2 Dry Eye Disease Trial
-Phase 2 OK-101 efficacy
data to be released March 22nd, 2024-
-KOL Event to be held on April 9th, 2024 at
12 PM ET-
LONDON and NEW YORK, March 21, 2024 (GLOBE
NEWSWIRE) -- OKYO Pharma Limited (NASDAQ: OKYO), a clinical-stage
biopharmaceutical company developing innovative ocular therapies
for the treatment of inflammatory dry eye disease (DED), a
multi-billion-dollar market, and anterior ocular segment diseases
including neuropathic corneal pain (NCP), an ocular condition
associated with pain but without an FDA approved therapy, announces
that it will be hosting a Key Opinion Leader (KOL) event on April
9th, 2024 at 12:00 PM ET to discuss in depth the findings of the
new and comprehensive efficacy data readout from the Phase 2 trial
of OK-101 in dry eye disease, which will be announced on March
22nd, 2024.
The event will feature Jay Pepose, MD, PhD, who
will review details from the company's Phase 2 trial evaluating
OK-101 in Dry Eye Disease, and Anat Galor, MD, MSPH who will
discuss the unmet need for a topical treatment that improves ocular
pain and differentiating features of OK-101. OKYO Pharma’s
management team will also be in attendance to present an overview
of OK-101’s mechanism of action.
Event details:
Date: Tuesday, April 9th, 2024
Time: 12:00 PM ET
Link To Register:
https://lifescievents.com/event/okyo/
Jay Pepose, MD, PhD, Founder and Medical
Director of the Pepose Vision Institute and Professor of Clinical
Ophthalmology at Washington University School of Medicine, has
nearly 40 years of experience as both a treating physician and a
widely published researcher. He is the founder and Medical Director
of the Pepose Vision Institute and a professor of Clinical
Ophthalmology & Visual Sciences at Washington University School
of Medicine in St. Louis. Dr. Pepose is actively involved in
clinical trials and has served as an investigator on over 30
studies evaluating new therapeutics and technology in a broad range
of ophthalmic indications, including dry eye. He has published over
200 peer-reviewed articles and has served on the editorial boards
of several prestigious ophthalmology journals. Dr. Pepose received
an A.B. and M.A. in neurophysiology from Brandeis University and
completed the M.D. Ph.D. program at the UCLA School of Medicine.
Dr. Pepose completed his ophthalmology residency at the Wilmer
Institute at the Johns Hopkins Medical Center and his fellowship
training at Georgetown University Medical Center.
Anat Galor, MD, MSPH, Professor of
Ophthalmology, University of Miami Miller School of Medicine, is a
cornea and uveitis trained specialist with dual appointments at the
Bascom Palmer Eye Institute and the Miami VA medical center. Dr.
Galor completed an ophthalmology residency at the Cole Eye
Cleveland Clinic, a uveitis fellowship at the Wilmer Eye Institute,
and a cornea and external diseases fellowship at Bascom Palmer Eye
Institute. Dr. Galor currently runs the ocular surface pain program
at the Bascom Palmer Eye Institute and the Miami VA and has focused
her research on understanding mechanisms of pain in dry eye, with
an emphasis on studying new diagnostic and treatment
modalities.
In a previous preliminary data readout, OK-101
showed statistically significant drug effects in FDA-recognized
efficacy endpoints as early as the 15-day first visit after dosing.
Additionally, statistically significant improvements were observed
in both a “sign” (total conjunctival staining) and two “symptoms”
(burning/stinging and blurred vision), which are FDA-recognized
endpoints of dry eye disease.
OK-101 Phase 2 Trial in DED
Patients
The double-masked, randomized, placebo-controlled Phase 2 trial was
conducted at six sites in the U.S. and enrolled 240 subjects with
DED dosed twice-daily (BID). Patients were randomly divided into 3
cohorts, with one of the cohorts dosed with 0.05% OK-101 (n=81), a
second with 0.1% OK-101 (n=80), and the third cohort with vehicle
(n=79). The duration of a patient’s treatment was 14 weeks,
including a 2-week run-in period on placebo, to exclude placebo
responders from the study, followed by 12 weeks in the randomized
portion of the study.
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 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 efficacy signals in mouse models of dry eye disease
and corneal neuropathic pain (NCP), respectively, and is designed
to combat washout through the inclusion of the lipid anchor built
into the drug molecule to enhance the residence time of OK-101
within the ocular environment. OK-101 recently showed statistical
significance in multiple endpoints in a recently completed Phase 2,
multi-center, double-blind, placebo-controlled trial of OK-101 to
treat DED.
About OKYO
OKYO Pharma Limited (NASDAQ: OKYO) is a clinical stage
biopharmaceutical company developing innovative therapies for the
treatment of 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. In addition to the recently completed Phase 2 DED trial, OKYO
also has plans underway for the opening of a Phase 2 trial for
OK-101 to treat NCP in patients with this debilitating condition.
For further information, please visit www.okyopharma.com.
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.
Enquiries:
OKYO Pharma
Limited |
Gary S. Jacob, Chief Executive
Officer |
917-497-7560 |
Business Development
& Investor Relations |
Paul Spencer |
+44 (0)20 7495 2379
|
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