How DARC Works
DARC Technology is an exploratory retinal biomarker for use in AMD & glaucoma clinical studies.
What is a biomarker?
A biomarker (short for biological marker) is defined as a characteristic that can be objectively measured and evaluated as an indicator of the presence or severity of some disease state or physiological stage of an organism.
In drug development, a clinical outcome or endpoint, often observed from the patient’s viewpoint, is defined as a characteristic or variable that reflects how a patient feels, functions or survives.
When evaluating potential therapeutics, if a treatment alters the biomarker, which has a direct connection to improved health or disease activity, a biomarker may serve as a surrogate endpoint for evaluating the clinical benefit of the therapeutic in trial. Surrogate endpoints are often regarded as more readily accessible and faster measures of treatment response or disease activity than natural clinical endpoints.
In chronic neurodegenerative diseases such as Glaucoma and Parkinson’s Disease, where patients can progress slowly and are followed up over long periods of time, it is important to obtain reliable indicators to measure progression of disease and the effectiveness of treatments. In glaucoma, the ‘gold standard’ for diagnosis is visual field tests; however, visual field defects can take many years to develop, during which irreversible cell damage has already occurred. Similarly, in Parkinson’s Disease, the condition is only diagnosed once a patient has presented with symptoms, at which point 70% of brain function has typically been lost.
DARC technology offers a brighter future and holds potential as a surrogate marker for many disease areas.
What is DARC?
DARC Technology is an exploratory retinal biomarker for use in AMD & glaucoma clinical studies.
DARC combines an innovative patented biologic with a state-of-the-art AI algorithm. For the first time in humans, using standard imaging equipment, DARC is able to identify cellular level disease activity.
DARC (Detection of Apoptosis in Retinal Cells) has been developed by Professor M Francesca Cordeiro at University College London through Wellcome Trust funding. Francesca Cordeiro is a Professor at UCL Institute of Ophthalmology and Imperial College London and is Director of the clinical trials unit at The Western Eye Hospital.
DARC uses a genetically modified Annexin, a naturally occurring cellular protein, combined with a fluorescent dye, which has a natural affinity to bind with phosphatidylserine.
DARC can individually detect sick, stressed and apoptosing cells.
How DARC Works.
DARC relies on the fact that cell membranes change their properties under stress and apoptosis.
Mammalian cells have a phospholipid bilayer surrounding them. Phosphatidylserine is a phospholipid that normally sits on the inner (cytosolic) layer of the cell membrane but under stress, sickness or apoptosis moves to the outer (extracellular) membrane.
The process of phosphatidylserine externalisation is reversible, allowing sick or stressed cells to return to a healthy state if appropriately targeted by treatments.
DARC is the biomarker that binds to the exposed phosphatidylserine to allow identification of sick, stressed and apoptotic cells. The fluorescent label of the biomarker allows it to be imaged, non-invasively and in real-time, using standard imaging equipment.
DARC allows the opportunity to not only monitor disease activity (DARC count) but also treatment efficacy (reduction in DARC count).
The DARC Process.
DARC is currently formulated as an intravenous injection which is administered to the patient 2 hours before image capture. Individual sick, stressed and apoptosing cells are then visible as white spots on the image. Using our patented AI Algorithm, the number and pattern of distribution of these spots can be quantified, allowing the clinician to identify patients with active disease and at high risk of progression in glaucoma or AMD.
DARC can be used to measure the impact of current and future therapeutics and interventions by assessment of disease activity.
DARC can identify non-responders to existing and new interventions, resulting in the avoidance of costly, ineffective or un-required medical management.
DARC can help stratify patients in clinical trials, resulting in the creation of enriched patient cohorts, consisting of those at highest risk of rapid disease progression.
Other Indications.
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 manifestation of Multiple Sclerosis) and Down’s Syndrome (as a model of Alzheimer’s Disease). Extensive pre-clinical work has been undertaken in other indications including: Parkinson’s Disease (PD), Diabetes Mellitus and Cancer.
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Dr. Alex Wilson,
Director of Corporate Development & Quality
