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 it is 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.
The OKYO Pharma has dry eyes as a lucrative prize in its sights is earmarked for December 2021.
In late March, 201, the company appointed Dr Rajkumar Patil as its chief scientific officer.
OKYO said Patil brings 30 years of ophthalmic and pharmaceutical research & development experience.
What the boss says: Willy Simon, chief executive
“Large market potential and growth exists for GPCR targeted drugs for treating a wide variety of indications such as inflammation, oncology, cardiovascular diseases and inflammatory eye diseases including dry eye, uveitis and allergic conjunctivitis.
“As such, it is the intention that the company will work closely with its retained clinicians with a view to generating incremental value for its shareholders.”
Inflection points
- 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