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OKYO Pharma Plans Q4 2022 IND Filing of OK-101 to treat Dry Eye Disease with Subsequent Phase 2 Initiation Alongside Peptide Manufacturing Partner, AmbioPharm OK-101 to treat ocular diseases, including Dry Eye Disease (D

Key Takeaway: Pharma Plans Q4 2022 IND Filing of OK-101 to treat Dry Eye Disease with Subsequent Phase 2 Initiation Alongside Peptide Manufacturing OK-101 to treat ocular diseases, including Dry Eye Disease (DED), uveitis, allergic conjunctivitis, and ocular pain. Successful pre-IND meeti

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Pharma Plans Q4 2022 IND Filing of OK-101 to treat Dry Eye Disease with Subsequent Phase 2 Initiation Alongside Peptide Manufacturing
OK-101 to treat ocular diseases, including Dry Eye Disease (DED), uveitis, allergic conjunctivitis, and ocular pain.
Successful pre-IND meeting with FDA in Q1 2022 and novel speed to market potential.
IND filing on OK-101 to treat DED planned for Q4 2022, with first human trial designed as Phase 2 trial planned to begin in Q1 2023.
Multibillion-dollar DED market whose medical needs remain largely unmet.
AmbioPharm supporting OK-101 program with peptide synthesis and development.
and New York, N.Y., and North Augusta, S.C. 30 August 2022
Pharma Limited (NASDAQ: OKYO; LSE: OKYO), a biotechnology company focused on the discovery and development of novel molecules to
treat inflammatory dry eye diseases and ocular pain, plans a Q4 2022 IND filing for OK-101 to treat dry eye disease (DED), with
AmbioPharm playing a key role in peptide manufacturing and development.
is a lipid-peptide analog developed using a novel membrane-anchored peptide (MAP) technology. It consists of a 12 amino acid peptide
sequence, a linker component, and an anchoring lipid domain. OK-101 is designed to increase the potency and combat ocular washout through
the inclusion of the lipid anchor' contained in the molecule to enhance the residence time within the ocular environment.
The OK-101 drug candidate displays potent anti-inflammatory activity in animal models of DED. OK-101 also reduces Corneal Neuropathic
Pain (CNP) in a ciliary nerve ligation animal model of CNP. Inflammation and pain are the two main symptoms of DED, and inflammation
is believed to be a major driver of the DED condition.
has novel speed-to-market potential by skipping a Phase I trial as the drug is administered topically, and by designing its Phase
2 trial effectively as a Phase 3 registration trial. Additionally, animal studies have shown no adverse effects of the drug.
Q1 2022, OKYO had a successful pre-IND meeting with the FDA and the FDA concurred with OKYO's plan to prespecify co-primary efficacy
endpoints of DED disease in the planned Phase 2 clinical trial. The Phase 2 trial, designed as effectively a Phase 3 registration trial,
if successful, would accelerate the timeline to new drug application (NDA).
remains largely a major unmet medical need as approved drugs, to date, still leave many patients unsatisfied. Consequently, there is
multi-billion-dollar market potential for an effective drug with minimal side effects to treat this disease.
is supporting the OK-101 program with peptide synthesis and development. A peptide contract development and manufacturing organization
(CDMO) providing cGMP peptide APIs with capabilities ranging from research to commercial scales, AmbioPharm actively engages with innovative
biopharmaceutical companies in developing first-in-class, best-in-class, and breakthrough peptide technologies that utilize AmbioPharm's
peptide manufacturing expertise and in-depth scientific experience in novel and conventional peptide chemistry. "The OK-101 program
is a perfect fit for our dynamic business model, which helps our partners by providing high quality products and services with a highly
competitive cost structure," said Michael W. Pennington, Ph.D., Chief Scientific Officer of AmbioPharm Inc.
are absolutely delighted to have AmbioPharm, a global leader in the synthesis of peptides and peptide analogs, manufacturing our drug
candidate OK-101," said Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma Ltd. "The work performed by Ambiopharm
during this post-COVID 19 period to keep us on schedule with the manufacture of API went above and beyond the call of duty and was a
testament to the high standards that AmbioPharm abides by."
Pharma Limited (NASDAQ: OKYO; LSE: OKYO) is a life sciences and biotechnology company recently listed on Nasdaq and admitted to listing
on the standard segment of the Official List of the UK Financial Conduct Authority and to trading on the main market for listed securities
of London Stock Exchange plc.
further information, please visit www.okyopharma.com/
a part of the Ambio Pharmaceuticals Group, is a leading and innovation-driven company specializing in the development and manufacture
of peptides and peptide-related products. With a comprehensive range of services, AmbioPharm produces custom products for research, clinical
development, and commercial application to pharmaceutical and biotechnology companies worldwide.
information is available at www.ambiopharm.com.
statements made in this announcement are forward-looking statements including with respect to the creation of a trading market for ADSs
representing the Ordinary Shares in the United States. 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, including market conditions. We caution you therefore against relying on any of these forward-looking statements. Important
factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation,
our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any
infringement actions or other litigation brought against us; competition from other providers and products; our ability to develop and
commercialize products and services; changes in government regulation; our ability to complete capital raising transactions; and other
factors relating to our industry, our operations and results of operations. . 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.
S. Jacob, Ph.D., Chief Executive Officer
DaFonseca, EVP, Sales & Global Business Development
Last updated: Aug 30, 2022