OKYO Pharma Ltd (LSE:OKYO, NASDAQ:OKYO, OTCQB:EMMLF) said it will work with US group AmbioPharm on an investigational new drug (IND) filing of dry eye disease (DED) treatment OK-101.
A US IND filing is expected in the final quarter of 2022, OKYO reiterated today, with a first human trial scheduled for early in 2023.
OKYO added this will be a phase 2 trial, skipping the normal phase 1 study, as the drug is administered topically.
As well as DED, OK-101 is also being considered as a candidate for uveitis, allergic conjunctivitis, and ocular pain.
AmbioPharm is supporting the OK-101 program with peptide synthesis and development, said OKYO.
Michael Pennington, Ambiopham’s chief scientific officer, said: "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."
Gary Jacob, OKYO’s CEO noted: "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."
DED remains largely a major unmet medical need as approved drugs, to date, still leave many patients unsatisfied, said OKYO.
"Consequently, there is multi-billion-dollar market potential for an effective drug with minimal side effects to treat this disease."