DARC’s development pathway will see it taken to Phase III trial for approval as a diagnostic. This will allow clinicians the ability to diagnose glaucoma and AMD years ahead of the current standard of care, allowing earlier intervention and treatment of the disease, before patients develop any functional vision loss.
As a consequence of truly prophylactic treatment, patients may potentially never experience vision loss. Patients with established disease can expect better care as DARC Technology improves management.
DARC is currently administered via intravenous injection but we will quickly move to re-formulate to a non-invasive intranasal spray. The PoC for this work has already been completed, and we expect this change of posology within 12 months.
DARC is already approved as an exploratory biomarker for glaucoma and AMD. Following further analysis of our Phase II data, several other indications may follow.
Phase II data included patients with Optic Neuritis (as a marker for MS) and Down Syndrome patients (as a marker for Alzheimer’s Disease).
Extensive pre-clinical work has been undertaken in other indications including: Parkinson’s Disease (PD), Diabetes Mellitus and Cancer.
TARGETED DRUG DELIVERY
DARC is currently a bipolar molecule which acts by binding to exposed phosphatidylserine whilst carrying a fluorescent dye. In the future we will enhance this molecule by conjugating a third binding site which will allow companies the ability to give targeted drug delivery specifically to sick and dying cells.
NOVEL NEURO-PROTECTIVE AGENT
ILLUSTRATUM owns the IP for FCX1-008 which has undergone extensive pre-clinical investigation and demonstrates high neuro-protective capabilities.
FCX1-008 is a derivative of turmeric and has demonstrated to be effective in reducing the rate of RGC death as measured by DARC in pre-clinical and in-vivo studies. The anticipated reduction in progression of glaucomatous damage is 30% which is comparable to the most effective Intra Occular Pressure (IOP) treatments currently used.
We hope FCX1-008 eye drops will be indicated as a “neuro-protective” agent for patients with glaucoma, following a successful clinical development programme.
We have data showing inhaled FCX1-008 reduced Alzheimers disease and DARC count in the retina in transgenic models.