Portage Biotech has announced the formation of EyGen, Ltd. a new ophthalmic company focused on developing preclinical ophthalmology assets through proof of concept. EyGen's lead asset is PPL-003, a potent anti-inflammatory created by Portage Pharmaceuticals Limited and being developed for topical ophthalmic delivery in patients with ocular surface and anterior segment diseases. This agent has the potential to become a new standard of care for the millions of people globally who suffer from dry eye disease. PPL-003 has demonstrated steroid-like efficacy in animal disease models without steroid-like side effects, the profile for an ocular anti-inflammatory targeting NFkB that has been an elusive goal for many years.
EyGen's CEO, Bruce H. Littman, M.D., has put together a seasoned management team that will develop PPL-003 as a topical eye drop therapy for dry eye disease before exploring other ocular inflammatory diseases. PPL-003 eye drops are well tolerated in animal studies to date and have demonstrated efficacy in mouse, rabbit and rat models of dry eye disease and uveitis. EyGen is working with leading experts in the development of ophthalmic products.
EyGen is seeking $1.5 million from external investors for working capital to complete formulation work for PPL-003 and to perform additional animal studies prior to a pre-IND meeting in mid-2017. Following regulatory agreement on a clear path forward and a successful Series A financing, the company will move PPL-003 rapidly to a clinical proof of concept: the demonstration of steroid-like efficacy in dry eye disease without the steroid-associated adverse events such as glaucoma and cataract formation. The dry eye disease market is growing and has a substantial unmet medical need. A safe topical drug with steroid-like efficacy could find broad use in many other inflammatory ocular diseases. Additionally, EyGen will continue to identify new preclinical opportunities in ophthalmology with the goal of creating a diversified pipeline of ophthalmology assets and driving them through proof of concept.
"PPL-003's broad mechanism of action makes it an ideal targeted drug for dry eye disease, and I believe it will set a new standard for efficacy for dry eye therapies," says Dr. Bruce Littman, EyGen's new CEO.
"I am excited about the development of PPL-003 in Dry Eye Disease and potentially other inflammatory eye disorders. In vivo data from various animal models support advancing PPL-003 into the clinic," says Dr. Burt Adelman, a Portage Pharmaceuticals Ltd. Scientific Advisory Board member and experienced biologics industry executive.
Portage Biotech Inc.'s wholly owned subsidiary Portage Pharmaceuticals, Ltd. (PPL), having discovered CellPorter®, a human-derived cell penetrating peptide platform for intracellular-targeted biologics and spun out its first successful development program into EyGen, Ltd., is also raising $1,000,000 of capital to finance its operations and the discovery and development of additional CellPorter® drugs for intracellular targets in dermatology, oncology, and other therapeutic areas.
PPL has demonstrated that the CellPorter® platform can ferry cargoes into cells in most compartments of the body and that its cargo remains biologically active once delivered. CellPorter® has also been shown to cross the blood-brain barrier without disruption to cell membranes, allowing drug developers ready access to a difficult-to-drug organ system. CellPorter® also has been shown to facilitate CD8 T-cell immune responses suggesting it may be useful in the development of vaccines.
PPL is currently testing CellPorter's ability to transport peptide drug cargos into the skin: if these experiments are successful they will validate Cellporter® as a novel and exciting dermatological delivery system capable of addressing previously undruggable targets. PPL and EyGen will continue to partner on additional ophthalmological therapeutics. Finally, and in parallel, PPL is conducting studies to demonstrate that CellPorter® can deliver intracellular peptide drug cargos that target key oncogenic pathways to treat cancer. PPL management believes that CellPorter's ability to access intracellular targets will give it a marked advantage in drug development by opening up new targets for biological drugs and allowing the company to make use of decades of work done on peptide therapeutics. PPL's next phase of development will also leverage new and ongoing collaborations to create additional lead candidates in different therapeutic areas.
Declan Doogan, M.D., Portage Biotech's CEO, commented, "The Portage team has shown the CellPorter® technology can deliver payloads into cells and help solve drug delivery problems as well as opening new therapeutic opportunities. I am excited by the potential of the PPL platform: these parallel leads across diverse therapeutic areas help spread development risk and make R&D investment more efficient".