- OK-101 to treat eye diseases including dry eye disease (DED), uveitis, allergic conjunctivitis and eye pain.
- Successful pre-IND meeting with FDA in Q1 2022 and potential new speed to market.
- IND filing on OK-101 to treat DED is scheduled for Q4 2022, with the first-in-human trial designed as a Phase 2 trial to begin in Q1 2023.
- Multi-billion dollar DED market whose medical needs remain largely unmet.
- AmbioPharm supports the OK-101 program with the synthesis and development of peptides.
LONDON and NEW YORK and NORTH AUGUSTA, SC, Aug. 30, 2022 (GLOBE NEWSWIRE) — OKYO Pharma Limited (NASDAQ: OKYO; LSE: OKYO), a biotechnology company focused on the discovery and development of new molecules to treat dryness inflammatory eye diseases and eye 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.
OK-101 is a lipid-peptide analog developed using novel membrane-anchored peptide (MAP) technology. It consists of a 12 amino acid peptide sequence, a binding component and an anchor lipid domain. OK-101 is designed to increase potency and combat ocular washout through the inclusion of the lipid “anchor” contained within the molecule to improve dwell time in the ocular environment. Drug candidate OK-101 exhibits potent anti-inflammatory activity in animal models of DED. OK-101 also reduces corneal neuropathic pain (CNP) in an animal model of ciliary nerve ligation of CNP. Inflammation and pain are the two main symptoms of DED, and inflammation is thought to be a major factor in the condition DED.
OK-101 has new speed-to-market potential skipping a phase I trial because the drug is administered topically, and effectively designing its phase 2 trial as a registration phase 3 trial. Additionally, animal studies have shown no adverse effects of the drug.
In the first quarter of 2022, OKYO had a successful pre-IND meeting with the FDA and the FDA approved OKYO’s plan to pre-specify co-primary efficacy parameters for DED disease in the phase clinical trial 2 planned. The phase 2 trial, designed as efficiently as a registration phase 3 trial, if successful, would speed up the New Drug Application (NDA) timeline.
DED remains largely a major unmet medical need, as the drugs approved, to date, still leave many patients unsatisfied. Therefore, there is a multi-billion dollar market potential for an effective drug with minimal side effects to treat this disease.
AmbioPharm supports the OK-101 program with the synthesis of peptides 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 the development of first-in-class peptide technologies. order, best-in-class, groundbreaking products that utilize AmbioPharm’s peptide manufacturing expertise and deep scientific background 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 very competitive cost structure,” said Michael W. Pennington, Ph.D., Director scientist from AmbioPharm inc.
“We are absolutely delighted that AmbioPharm, a world leader in the synthesis of peptides and peptide analogues, is manufacturing our drug candidate OK-101,” said Gary S. Jacob, Ph.D., CEO of OKYO Pharma Ltd. “The work AmbioPharm has done during this post-COVID 19 period to keep us on schedule with API manufacturing has gone beyond the call of duty and is testament to the high standards that AmbioPharm adheres to.
OKYO Pharma Limited (NASDAQ: OKYO; LSE: OKYO) is a life sciences and biotechnology company recently listed on the Nasdaq and admitted to the standard segment of the official list of the UK Financial Conduct Authority and to trading on the main market for listed products. securities of London Stock Exchange plc.
For more information, visit www.okyopharma.com/
AmbioPharm, part of the Ambio Pharmaceuticals group, is a leading, innovation-driven company specializing in the development and manufacturing of peptides and peptide-related products. With a full range of services, AmbioPharm manufactures customized products for research, clinical development and commercial application to pharmaceutical and biotechnology companies worldwide.
Further information is available at www.ambiopharm.com.
Certain statements made in this announcement are forward-looking statements, including with respect to the creation of a trading market for ADSs representing common stock 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 regarding its industry; his 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 control of the Company, are difficult to predict and could cause actual results differ materially from those expressed or anticipated. in forward-looking statements, including market conditions. We therefore advise you not to rely on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those set forth in the forward-looking statements include, but are not limited to, our ability to raise capital to fund continuing operations; our ability to protect our intellectual property rights; the impact of any infringement or other litigation brought against us; competition from other suppliers and products; our ability to develop and market products and services; changes in government regulations; our ability to complete capital raising transactions; and other factors relating to our industry, operations and results of operations. . The Company cautions securityholders and potential securityholders not to place undue reliance on these forward-looking statements, which reflect the Company’s views only as of the date of this announcement. Forward-looking statements made in this announcement relate only to events as of the date the statements are made. The Company undertakes no obligation to publicly release revisions or updates to these forward-looking statements to reflect unforeseen events, circumstances or developments occurring after the date of this announcement, except as required by law or any applicable regulatory authority. ‘required.
Gary S. Jacob, Ph.D., President and CEO
Phone: (212) 209-3998
Mark DaFonseca, Executive Vice President, Global Sales and Business Development