OKYO Pharma Announces Filing of an Investigational New Drug (IND) Application for OK-101 to Treat Neuropathic Corneal Pain (“NCP”)
October 09 2023 - 7:00AM
OKYO Pharma Announces Filing of an Investigational New Drug (IND)
Application for OK-101 to Treat Neuropathic Corneal Pain
(“NCP”)
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, a
severe ocular condition with no FDA approved therapy, today
announced that it filed an Investigational New Drug (IND)
application with the U.S. Food and Drug Administration (FDA) for
the development of OK-101 to treat Neuropathic Corneal Pain (NCP).
Study enrollment is planned to commence during Q1 2024 following
IND allowance by the FDA.
NCP remains a major unmet medical need for the ocular community,
as there is no FDA-approved drug to treat NCP and this trial
provides the opportunity to establish OK-101’s potential to treat
this condition. The open-label trial will provide an opportunity to
evaluate the safety and efficacy of OK-101 for NCP in a real-world
clinical setting, fostering a better understanding of its potential
benefits for patients.
The NCP trial will be led by Pedram Hamrah, MD, Professor and
Vice Chair of Research and Academic Programs, Co-Director of the
Cornea Service and Director of the Center for Translational Ocular
Immunology at Tufts Medical Center. An ophthalmologist and a
clinician-scientist, Dr. Hamrah is a leading expert in NCP and
co-inventor on the OK-101 patent. He is a member of OKYO’s
Scientific Advisory Board and plans to serve as Principal
Investigator of the study, which will be conducted at Tufts Medical
Center.
“NCP, which can exhibit as a severe, chronic or debilitating
condition in patients suffering from a host of ophthalmic
conditions, is presently treated by various topical and systemic
treatments in an off-label fashion,” said Dr. Hamrah. “However,
there are no approved commercial treatments currently available for
this condition, and consequently we are looking forward to
initiating the clinical trial to investigate the potential efficacy
of OK-101 to treat symptoms of NCP.”
“We are excited about OK-101’s dual combination of
anti-inflammatory ocular activity and NCP reducing activity and are
eager to evaluate this drug to treat NCP while awaiting the
top-line data for OK-101 from the ongoing Phase 2 DED trial which
is planned for released in December 2023,” said Dr. Gary S. Jacob,
CEO of OKYO.
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 the OK-101 Phase 2 DED 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 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.
Forward-Looking StatementsCertain 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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