Ophthalmology-focused biotechnology company OKYO Pharma Ltd. (OKYO:NASDAQ; OKYO:LSE), which concentrates its efforts on discovering and developing novel molecules to treat inflammatory eye diseases such as allergic conjunctivitis, dry eye disease, uveitis, and ocular pain, today announced that during Q4/22 it plans to submit an Investigational New Drug Application (IND) request to the U.S. Food and Drug Administration (FDA) for its lipid-peptide analog OK-101 for use in the treatment of dry eye disease (DED).
The firm noted that during the process, it will be working very closely with its manufacturing partner AmbioPharm Inc., which will provide OKYO Pharma with the expertise needed in peptide synthesis, manufacturing, and development to support the OK-101 program and a subsequent first-in-human Phase 2 clinical trial planned for Q1/23.
The company explained that "OK-101 is a lipid-peptide analog developed using a novel membrane-anchored peptide (MAP) technology that consists of a 12 amino acid peptide sequence, a linker component, and an anchoring lipid domain."
The firm indicated that OK-101 serves to increase potency and limit the effects of ocular washout due to the naturally occurring processes of tearing and blinking. OK-101 is designed to minimize the drug residence time required at the ocular site while still delivering pharmacologic benefits.
The company advised that OK-101 has been shown to offer potent anti-inflammatory activity in animal studies pertaining to DED. The firm commented that these animal studies displayed no adverse effects from the drug. In addition, OKYO mentioned that in a ciliary nerve ligation animal model of Corneal Neuropathic Pain (CNP), OK-101 demonstrated the ability to reduce CNP.
The firm pointed out that "inflammation and pain are the two main symptoms of DED, and inflammation is believed to be a major driver of the DED condition."
OKYO stated that OK-101 has the potential to be fast-tracked to market. Since the drug is topically administered, it was able to bypass Phase I trials, and its upcoming Phase 2 trial is being designed for all intents and purposes as a Phase 3 registration trial.
The company stated that during a pre-IND meeting with the FDA in Q1/22, the FDA agreed with its plans for establishing co-primary efficacy endpoints for its Phase 2 DED disease clinical trial. OKYO noted that the Phase 2 study is effectively structured as a Phase 3 registration trial and that if it proves to be successful would allow for rapid acceleration of the NDA timeline.
The company said that DED presents a large unmet medical need because the medications that have been approved so far have left many patients largely unsatisfied with the results.
AmbioPharm's Chief Scientific Officer Michael W. Pennington, Ph.D., remarked, "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."
OKYO Pharma's CEO Gary S. Jacob, Ph.D., commented, "We are absolutely delighted to have AmbioPharm, a global leader in the synthesis of peptides and peptide analogs, manufacturing our drug candidate OK-101 … 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."
OKYO Pharma is a biopharma firm headquartered in London, U.K., that is focused on developing novel medicines to treat dry eye diseases and ocular pain. The company is currently developing OK-101, a lipidated chemerin-peptide drug candidate, which is engineered to target a key ocular receptor that is believed to control inflammation and ocular pain. OK-101 is being developed as a treatment for several ocular diseases, including allergic conjunctivitis dry eye, uveitis along with ocular pain though at present, its primary emphasis is centered on treating treat dry eye disease (DED).
OKYO Pharma's manufacturing and development partner AmbioPharm is a member of the Ambio Pharmaceuticals Group. Ambio specializes in creating, developing, and manufacturing peptides and peptide-related products and produces tailor-made products for use in pharmaceutical research, clinical development studies, and commercial applications.
OKYO Pharma started the day with a market cap of around $40.98 million with approximately 21.77 million shares outstanding. OKYO shares opened 11.5% higher today at $2.22 (+$0.23, +11.56%) over yesterday's $1.99 closing price. The stock has traded today between $2.10 and $2.46 per share and is currently trading at $2.46 (+$0.47, +23.62%).
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