Okyo Pharma Ltd (LSE:OKYO, OTCQB:EMMLF) said its treatment for dry eye disease looks set to go straight into a phase II clinical trial in the fourth quarter of next year once its investigational new drug (IND) application has been approved.
The IND for lead asset OK-101 will be submitted in the third quarter of 2022.
The study, which will involve 100 to 200 people with dry eye disease, will be overseen by Ora Inc, the group’s ophthalmic clinical development partner. It is expected to be completed in six to eight months from first enrolment.
OKYO chief executive Gary Jacobs said the fact the drug would be topically administered directly to the eye made it likely that OKYO would be allowed to skip phase I. This initial stage tends to be focused on the safety of orally taken treatments and also looks at how they interact with the body. The phase II evaluation will assess efficacy.
Jacobs added: “We recognise that news-flow from the company has been limited over the past nine months; however in that time we have been focused on advancing all necessary IND-enabling studies on OK-101 and are now in a position to announce that we plan to file the IND to treat dry eye disease in Q3 2022.”
OK-101 is being developed as a long-acting anti-inflammatory drug candidate. The technology is based around G protein-coupled receptors typically found on immunological cells present in the eye. They act like an inbox for messages in the form of light energy, peptides that fight bacteria and promote wound healing, lipids, sugars, and proteins.
“Based on the anti-inflammatory response seen in pre-clinical models, this novel mechanism of action may prove to be a breakthrough treatment for the over 700 million dry eye disease patients globally,” said George Ousler, a senior vice president at Ora, the company’s development partner.
Currently, the two leading products for dry eye disease are Xiidra, created by Novartis (NYSE: NVS), and Restasis, developed by Abbvie (NYSE:ABBV) (NYSE: ABBV).