Naegis Pharmaceuticals Inc. (“Naegis”) a life sciences company focused on inflammation and ophthalmology, today announced the closing of a financing.
Over the next 12 months, the funding will support advancement of a patented lead compound through to approval of a U.S. FDA investigational new drug (IND) application to enter a phase 2 clinical trial.
Naegis secured investments from new investors including experienced Canadian investment funds, its clinical partner, the world’s leading ophthalmology clinical research organization, the venture arm of a major international ophthalmology company, certain high-net-worth individuals and its management and directors.
Naegis has achieved a breakthrough by addressing the underexploited leukotriene inflammatory pathway and its role in the development and progression of serious eye diseases.
Led by President and founder, Dr. David Burgoyne, Naegis’ scientists have discovered and patented a series of potent new compounds that block inflammatory disease in the eye by inhibition of a key, upstream, biological target that results in the release of damaging pro-inflammatory substances. The Company has received notification from the US Patent Office that a patent for its lead compound, N0651, will issue on May 7th, 2024.
N0651 has demonstrated, in multiple pre-clinical studies, remarkable ability to treat inflammatory diseases, of both the front and back of the eye, when administered either topically (by eye drops) or orally. The ability to deliver an effective disease reducing treatment by eye drop or oral therapy would be a game changer in the treatment of serious eye diseases, with the potential to disrupt the currently US$30 billion ophthalmology market. Current mainstay treatments for retinal diseases, such as macular degeneration and diabetic retinopathy, involve the administration of growth factor inhibitors or steroid compounds into the back of the eye by intra-ocular injection, which are both costly to healthcare systems and unpleasant for patients.
Leukotrienes and Their Role in Eye Inflammation?
Leukotrienes are a family of lipid mediators, produced in white blood cells, that are responsible for the stimulation and release of inflammatory substances. The leukotriene pathway and related molecules became a Nobel Prize winning discovery and have subsequently been clinically validated as important mediators in serious inflammatory and allergic diseases.
Stimulation of an inflammatory response is a normal host defence mechanism aimed at neutralizing and removing various irritants such as allergens, bacteria, dead cells etc. However, if inflammation in the eye is stimulated inappropriately or becomes chronic in nature (for example, as the result of drusen, waste-product build-up, on the retina) it can lead to the over expression of inflammatory cells and unwanted tissue remodeling. This then progresses on to damage to the highly sensitive vision cells resulting in partial or complete loss of sight.
The leukotriene pathway has two main branches, the cysteinyl-leukotriene (CysLT) branch and the leukotriene-B4 (LTB4) branch, which can act independently or together in various disease situations. The activation of each pathway is influenced by many different factors, such as cell type and receptor activation. Naegis’ N0651, blocks both leukotriene pathway branches and thus offers a broad-spectrum approach to treating various inflammatory eye diseases.
Ian McBeath, CEO of Naegis, stated:
“We believe that there is significant potential for our compounds to be disruptive of the $30 billion ophthalmology market. As our compounds can block both branches of the leukotriene pathway and are effective by eye drop or oral administration, they offer a real alternative to injections into the eye. We have been encouraged by the confidence shown in us by our knowledgeable investors and over the next 12 months the funding raised will allow us to complete the final steps to be able to submit an IND for a Phase 2 clinical study.”
Julian Gangolli, Chairman of Naegis and previously President North America for Allergan said:
“The promise of the Naegis technology is very exciting for patients and the whole of the ophthalmic industry. There has been a real need for some time for the ophthalmic industry to discover and address new pathways and provide alternative, effective and acceptable ways of treating various eye diseases.”
For further information please contact Ian McBeath – imcb@naegispharma.com
Naegis will be at ARVO, Seattle, May 5th – 9th, 2024.