LONDON & NEW YORK & NORTH AUGUSTA, S.C.– OKYO Pharma Limited (NASDAQ: OKYO; LSE: OKYO), a biotechnology company focused on the discovery and development of novel molecules to treat inflammatory dry eye diseases and ocular pain, plans a Q4 2022 IND filing for OK-101 to treat dry eye disease (DED), with AmbioPharm playing a key role in peptide manufacturing and development.
OK-101 is a lipid-peptide analog developed using a novel membrane-anchored peptide (MAP) technology. It consists of a 12 amino acid peptide sequence, a linker component, and an anchoring lipid domain. OK-101 is designed to increase the potency and combat ocular washout through the inclusion of the lipid ‘anchor’ contained in the molecule to enhance the residence time within the ocular environment. The OK-101 drug candidate displays potent anti-inflammatory activity in animal models of DED. OK-101 also reduces Corneal Neuropathic Pain (CNP) in a ciliary nerve ligation animal model of CNP. Inflammation and pain are the two main symptoms of DED, and inflammation is believed to be a major driver of the DED condition.
OK-101 has novel speed-to-market potential by skipping a Phase I trial as the drug is administered topically, and by designing its Phase 2 trial effectively as a Phase 3 registration trial. Additionally, animal studies have shown no adverse effects of the drug.
In Q1 2022, OKYO had a successful pre-IND meeting with the FDA and the FDA concurred with OKYO’s plan to prespecify co-primary efficacy endpoints of DED disease in the planned Phase 2 clinical trial. The Phase 2 trial, designed as effectively a Phase 3 registration trial, if successful, would accelerate the timeline to new drug application (NDA).
DED remains largely a major unmet medical need as approved drugs, to date, still leave many patients unsatisfied. Consequently, there is multi-billion-dollar market potential for an effective drug with minimal side effects to treat this disease.
AmbioPharm is supporting the OK-101 program with peptide synthesis and development. A peptide contract development and manufacturing organization (CDMO) providing cGMP peptide APIs with capabilities ranging from research to commercial scales, AmbioPharm actively engages with innovative biopharmaceutical companies in developing first-in-class, best-in-class, and breakthrough peptide technologies that utilize AmbioPharm’s peptide manufacturing expertise and in-depth scientific experience in novel and conventional peptide chemistry. “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,” said Michael W. Pennington, Ph.D., Chief Scientific Officer of AmbioPharm Inc.
”We are absolutely delighted to have AmbioPharm, a global leader in the synthesis of peptides and peptide analogs, manufacturing our drug candidate OK-101,” said Gary S. Jacob, Ph.D., Chief Executive Officer of OKYO Pharma Ltd. “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.”
