What OKYO does
OKYO Pharma Ltd’s (LON:OKYO) two main products in development are to treat eye inflammation and chronic pain.
Furthest down the road is the potential treatment for dry eye conditions, known for now as OK-113.
Based on pre-clinical tests, the company believes its candidate could prove superior to the current leading dry-eye product in the market, Allergan’s Restatis, which generates annual sales of US$1.2bn.
OKYO's drug inhibits Chemerin, one of a key group of cell surface receptors called G-protein coupled receptors (GPCRs), which play an important role in inflammation and were the basis of the 2012 Nobel Prize in Chemistry.
A second asset on the London-listed company’s books is a potential non-opioid pain relief product, which is at earlier stages of development but is a very hot topic in the US and addresses another massive market.
This potential treatment also focuses on GPCRs, specifically targeting the human Mas-Related G protein-coupled receptor (MRGPR) using a peptide going by the moniker of Bovine Adrenal Medulla 8-22 (BAM8-22).
OKYO's board is led by executive chairman Willy Simon, a former Citigroup banker, with the science directed by Kunwar Shailubhai, who some investors will know as from Tiziana Life Sciences.
How they are doing
OKYO is preparing for dry eye candidate OK-113 to enter Phase I clinical trials in 20-30 patients in the first quarter of next year.
This follows successful animal studies and side-by-side tests against Restatis, where it compared well, with no local irritation caused, unlike its rival.
Assuming all goes well, Shailubhai said a Phase II study in around 100 patients would come later next year.
As the effectiveness of the drug can be determined in less than 24 hours, the plan would be to run a Phase II trial for four weeks and even a Phase III should not last more than a couple of months, according to Shailubhai.
In pain relief, the BAM8-22 peptide was shown in animal studies to block both inflammatory and neuropathic pain after nerve injury, suggesting it may be one of a class of non-opioid analgesics for treating chronic pain with minimal side effects.
Having obtained an intellectual property licence from Tufts University for BAM8, OKYO is working with Tufts professor Pedram Hamrah to evaluate proprietary lead compounds as non-opioid analgesics, which will provide further proof-of-concept results.
A scientific advisory board has been created ahead of the launch of clinical trials, with two industry heavyweights added in August: leading US eye surgeon Dr A James Khodabakhsh and Dr Napoleone Ferrara, an award-winning scientist who helped invent blockbuster eye drug Lucentis.
What they say
“For dry eye, currently the market-leading product is Restasis eye drops but people do not feel very comfortable using it due to local irritation.
“But ours is a totally new concept. It removes the underlying infection and is non-toxic, and so I believe it is going to be superior to existing products,” said chief scientific officer Kunwar Shailubhai in August 2020.
Upon his appointment, James Khodabakhsh said: “There is a high failure rate in the available medications and significant side-effect profiles. In OKYO with our peptide we can significantly increase the effectiveness of topical medications and treat a lot more patients who are not responding to the present medications available.”
- Heavyweight appointments coming in
- Plans to start dry-eye Phase I clinical trials early in 2021
- Further developments expected in the early-stage chronic pain studies