This ophthalmology-focused bio-pharma company is developing its game-changing OK-101 drug candidate to treat dry eye disease (DED) – a condition that addresses a significant unmet need in a multi-billion-dollar market!
Now may be a critical time to have the company on your radar as only weeks ago, the U.S. Food and Drug Administration (FDA) cleared OKYO’s Investigational New Drug (IND) to initiate a Phase 2, first-in-human, clinical study of OK-101 for the treatment of DED!
“We are very pleased to receive clearance from the FDA to initiate our OK-101 Phase 2 study. We believe this first-in-human study will help demonstrate that OK-101 may provide a new way to treat DED patients who are not well-served by currently approved drugs. Based on earlier feedback from the FDA we are designating primary and secondary efficacy endpoints in this study that include both a sign and a symptom of the disease. Should our Phase 2 study meet its prespecified primary endpoint, it may accelerate the timeline to a new drug application (NDA) filing for OK-101 with the FDA. The clearance of our IND for OK-101 has been a key priority for the company this past year, and we are excited to be moving this drug into the clinic in the first quarter of 2023.”
Gary S. Jacob, Ph.D., Chief Executive Officer
The healthcare arena is just what the doctor ordered for 2023 as inflation continues and a recession looms. Healthcare is one of the most stable industries, and people will continue to spend money on medicine regardless of how the economy is doing.
Additionally, the World Health Organization (WHO) has estimated that the number of people who are aged 60 and older will almost double by 2050! The market will reach a staggering 426 million people.
What does this mean? It means more prescription drugs will keep older people healthy and active as their bodies wear down.
As baby boomers age, eye issues continue to boom. As more people spend their time on screens, eye issues continue to accelerate.
The growing eye industry is something investors can’t ignore much longer.
Of your five senses, eyesight ranks right at the top. And when eyes are affected by various conditions, people will do what they can to alleviate their symptoms and improve their eye condition.
Dry eye disease is one of the most common ocular eye conditions. It’s no surprise that the market has become extensive for dry eye drugs including brand names like Novartis’ Xiidra and Allergan’s Restasis.
These drugs are expensive too. Xiidra is not usually covered by Medicare insurance plans and there is no generic alternative available for Xiidra. Restasis is a prescription eye drop that increases tear production to relieve chronic dry eye and can also cost hundreds of dollars.
Not to mention that both drugs come with side effects, have inadequate efficacy, and a slow onset of action.
Healthcare research for the eyes is laying the groundwork for drug technology that has never been seen before and treatments and therapies are becoming more sophisticated with every passing year.
Being conscious of which companies are successful in capitalizing on innovative ways to treat eye problems could be advantageous for any portfolio!
What makes OKYO stand out in the DED treatment space is a new chemical entity that targets BOTH ocular inflammation and corneal neuropathic pain in dry eye disease! Something that has yet to be seen for any other drug!
OKYO Pharma Limited (Nasdaq: OKYO, LSE: OKYO) is a life sciences company developing next-generation therapeutics to improve the lives of patients suffering from inflammatory eye diseases and ocular pain.
OKYO’s research program is focused on a novel G Protein-Coupled Receptor (GPCR), which the company believes plays a key role in the pathology of these inflammatory eye diseases of high unmet medical need.
The company’s therapeutic approach is focused on targeting inflammatory and pain modulation pathways that drive these conditions.
OKYO is concentrating on the development of its drug candidate OK-101 to treat ocular diseases, including:
The immediate focus of the company is the clinical development of OK-101 to treat dry eye disease (DED).
In November 2022 the company filed an IND to treat DED with the U.S. Food and Drug Administration and plans to skip the normal Phase 1 trials conducted in volunteers and go straight to the initiation of a Phase 2 trial in 240 DED patients in the first quarter of 2023. This is just around the corner!
Your tears protect the surface of your eyes from damage. Damage to the corneal surface typically leads to ocular inflammation. If left untreated, severe ocular inflammation can lead to abrasion of the corneal surface, corneal ulcers and even vision loss.
Ocular pain can be caused by many issues including allergies, inflammation, headaches, contact lens problems, dry eyes, eyelid infections, and pink eye.
OKYO’s OK-101 is a promising candidate for the treatment of both inflammation and ocular pain.
OK-101 is a lipid-conjugated chemerin peptide agonist of the ChemR23 G-protein coupled receptor class which is typically found on immune cells of the eye responsible for the inflammatory response.
ChemR23 receptor on leukocytes targeted by OK-101 is also expressed on neurons and glial cells in the dorsal root ganglion and spinal cord.
OK-101 has been shown to produce anti-inflammatory and neuropathic pain-reducing activities in mouse models of DED 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.
For those who have dry eye disease (DED), they know exactly why it’s an inconvenience, People suffering from dry eyes have difficulty maintaining a healthy social life. It can also significantly reduce performance at work and make it difficult to enjoy things that they like to do.
DED makes life difficult on multiple levels. In addition to having an impact on visual acuity, the condition is chronic - there is no cure, and individuals can suffer from pain, itchiness, burning sensations, and blurry vision that interferes with their quality of life.
The global dry eye syndrome market size was USD $5.22 billion in 2019 and is projected to reach USD $6.54 billion by 2027, exhibiting a CAGR of 4.7% during the forecast period.
The increase in the prevalence of dry eye-related diseases may be attributed to a number of causes, including aging, a decline in supporting hormones, systemic inflammatory diseases, ocular surface diseases, or procedures that disrupt the cholinergic neurons that promote tear secretion.
According to a December 2021 article titled "Estimated Annual Economic Burden of Dry Eye Disease Based on a Multi-Center Analysis in China: A Retrospective Study," DED is now the fifth most common ocular condition in women and the ninth most common in men in the United States among those who need eye care.
OKYO’s focus is to suppress the inflammation and pain associated with the uveitis using our lead drug candidate OK-101.
OKYO spent the last 18 months stepping through a multiplicity of pre-clinical activities, including drug manufacture and formulation, animal toxicity studies, DED animal model studies, analytics development, GMP drug manufacturing scale-up, pre-IND meeting with FDA, and the generation of the IND package for submission to FDA. This work was facilitated by a strong collaboration with OKYO’s premier clinical CRO, ORA Inc. which has considerable proven experience in conducting dry eye disease trials.
The Pre-IND meeting was successfully conducted in February 2022. Both nonclinical and clinical development milestones were covered in the meeting, facilitated by Ora Inc., with the FDA agreeing with the company’s plan to skip phase 1 trials, and providing written guidance on the proposed phase 2 trial in DED patients. FDA concurred with OKYO’s decision to designate co-primary efficacy endpoints covering both a sign and a symptom of dry disease in the clinical protocol of the trial.
OKYO successfully obtained clearance from the FDA in December 2022 on its IND on OL-101 to treat DED patients and plans to open its phase 2 trial in 1Q 2023. The OK-101 timeline is shown below. What is noteworthy is the planned release of top-line data from the trial in 4Q 2023.
Approximately 5 million people suffer from ocular pain every year.
Neuropathic corneal pain, a severe, chronic, and debilitating disease for which there are no approved commercial treatments currently available.
Current treatments are limited to short term NSAIDs, steroids, and opioids in severe cases. Side effects and the risk of addiction to opioids is a serious concern.
The global ocular pain market is expected to reach half a billion dollars by 2030.
Topical administration of OKYO’s lead drug candidate OK-101 was effective in suppressing corneal pain in a ciliary nerve ligation mouse model of neuropathic corneal pain; exhibiting a potency similar to that of gabapentin, a commonly used oral drug for neuropathic pain that was conversely given by intraperitoneal injection.
The pain-relieving potential of a dry eye drug would provide an important benefit to the considerable number of dry eye patients suffering from ocular pain in addition to the existing inflammatory effects of the condition.
Dr. Jacob has over 35 years of extensive experience in the pharmaceutical and biotechnology industries across multiple disciplines, including research and development, operations, business development, capital financing activities and senior management expertise.
He has developed broad and influential contacts throughout the biopharmaceutical, financial, banking and investor communities. Dr. Jacob is the Co-Founder and former CEO and Chairman of Synergy Pharmaceuticals. During his time at Synergy, he served as Chairman, Chief Executive Officer and Executive Chairman, and is the co-inventor of Synergy’s FDA-approved drug Trulance® which is currently marketed in the U.S. by Bausch Health, Inc. to treat functional GI disorders. Dr. Jacob is also the former CEO and Managing Director of Immuron Inc., an Australian biotechnology company dual-listed on the Australian ASX exchange and on NASDAQ. Dr. Jacob currently is Chairman of the Board of Hepion Pharmaceuticals, Inc., a public NASDAQ listed company with a drug in clinical development to treat nonalcoholic steatohepatitis (NASH), and is also on the Board of Directors of Cardiff Oncology, Inc., a NASDAQ listed public oncology company. He served as Chief Executive Officer and Director of Callisto Pharmaceuticals, Inc. from May 2003 until January 2013.
Prior to his involvement with Callisto and Synergy, Dr. Jacob was at Monsanto/G.D. Searle, where he was Director of Glycobiology and a Monsanto Science Fellow, specializing in the field of Glycobiology and drug discovery. Dr. Jacob holds over 30 patents and is the co-inventor of two pharmaceutical drugs which are FDA approved. Dr. Jacob earned a B.S. cum laude in Chemistry from the University of Missouri, St. Louis and holds a Ph.D. in Biochemistry from the University of Wisconsin, Madison.
Dr. Patil brings 30 years of ophthalmic experience and a powerful combination of academic scholarship and pharmaceutical R&D excellence.
Raj previously worked with Ora Inc, as Vice President of Research & Development, where he was responsible for driving all anterior and posterior segment research of Ora’s R&D Institute. Earlier in his career, he worked at iVeena Delivery Systems as Vice President of Advanced Ocular Delivery Systems. His tenure at iVeena included a two-year sabbatical in Singapore, where he served as an Associate Professor of Ophthalmology at DUKE/NUS Medical School and Principal Investigator at Singapore Eye Research Institute.
Raj also held a number of leadership roles at Alcon/Novartis Institute of Biomedical Research, including Associate Director of Research and Head of Molecular Pharmacology glaucoma and retina research. Prior to joining the business world, Dr. Patil served as an Associate Professor of Ophthalmology, Cell Biology & Genetics at University of Nebraska Medical Centre in Omaha and as an Assistant Professor of Ophthalmology, Molecular Biology & Pharmacology at Washington University in St. Louis.
Raj received his PhD in Biochemistry from National Chemical Laboratory/University of Pune, India and completed his postdoctoral training in Biochemistry and Molecular Biology at the University of Michigan, Ann Arbor, MI. He is the recipient of Olga Keith Wiess Special Scholar Award from Research to Prevent Blindness Foundation and NIH Director’s New Innovator Award. Dr. Patil has authored over 50 peer-reviewed research articles and serves as reviewer and editorial board member for numerous journals and is frequently invited to lecture at academic and industry events.
Keeren Shah serves as our Chief Financial Officer. Ms. Shah currently also serves as the Finance Director of Tiziana Life Sciences LTD, Accustem Sciences Limited and Rasna Therapeutics Inc., having previously served as the Group Financial Controller for all businesses from June 2016 to July 2020. Prior to joining the Company, Ms. Shah spent 10 years at Visa, Inc. as a Senior Leader in its finance team where she was responsible for key financial controller activities, financial planning and analysis, and core processes as well as leading and participating in key transformation programmes and Visa Inc.’s initial public offering. Before joining Visa, Ms. Shah also held a variety of finance positions at other leading companies including Arthur Andersen and BBC Worldwide. She holds a Bachelor of Arts with honours in Economics and is a member of the Chartered Institute of Management Accountants.
This is one of the most exciting times for Okyo Pharma Limited (NASDAQ: OKYO) (LSE: OKYO) as it moves toward initiating a Phase 2, first-in-human, clinical study of OK-101 for the treatment of DED.
OKYO’s clinical plan represents an ambitious rapid timeline in the clinic to attain clinical results validating that the drug works.
If OKYO is successful in hitting its clinical trial efficacy endpoints before the end of this year, the Company could be in a strong negotiating position to clinch a business development partnership and/or potentially a trade sale to a Big Pharma focused on eye diseases.
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