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Detecting retinal cell stress and apoptosis with DARC: Progression from lab to clinic
Maria Francesca Cordeiro1, Daniel Hill2, Radhika Patel3
1UCL Institute of Ophthalmology, London, UK; Western Eye Hospital Imperial College Healthcare NHS Trust, London, UK; ICORG, Imperial College, London, UK; Novai Ltd, Reading, UK.
Abstract:
DARC (Detection of Apoptosing Retinal Cells) is a retinal imaging technology that has been developed within the last 2 decades from basic laboratory science to Phase 2 clinical trials. It uses ANX776 (fluorescently labelled Annexin A5) to identify stressed and apoptotic cells in the living eye. During its development, DARC has undergone biochemistry optimisation, scale-up and GMP manufacture and extensive preclinical evaluation. Initially tested in preclinical glaucoma and optic neuropathy models, it has also been investigated in AMD, Alzheimer's, Parkinson's and Diabetic models, and used to assess efficacy of therapies. Progression to clinical trials has not been speedy. Intravenous ANX776 has to date been found to be safe and well-tolerated in 129 patients, including 16 from Phase 1 and 113 from Phase 2. Results on glaucoma and AMD patients have been recently published, and suggest DARC with an AI-aided algorithm can be used to predict disease activity. New analyses of DARC in GA (Geographic Atrophy) prediction are reported here. Although further studies are needed to validate these findings, it appears there is potential for the technology to be used as a biomarker. Much larger clinical studies will be needed before it can be considered as a diagnostic, although the relatively non-invasive nature of the nasal as opposed to intravenous administration would widen its acceptability in the future as a screening tool. This review describes DARC development and its progression into Phase 2 clinical trials from lab-based research. It discusses hypotheses, potential challenges, and regulatory hurdles in translating technology.
Insights
Detection of Apoptosing Retinal Cells (DARC) imaging identifies stressed retinal cells. Recent studies suggest DARC, with AI, may predict disease activity and serve as a biomarker, particularly for Geographic Atrophy.
Area of Science:
- Ophthalmology
- Biomedical Imaging
- Cell Biology
Background:
- Detection of Apoptosing Retinal Cells (DARC) is a retinal imaging technology developed over two decades.
- It utilizes ANX776 (fluorescently labeled Annexin A5) to detect stressed and apoptotic cells in vivo.
- DARC has progressed through biochemistry optimization, scale-up, GMP manufacturing, and extensive preclinical evaluation.
Purpose of the Study:
- To review the development of DARC technology from laboratory research to Phase 2 clinical trials.
- To discuss the potential of DARC as a biomarker for predicting disease activity, including Geographic Atrophy (GA).
- To explore challenges and regulatory hurdles in translating DARC technology for clinical use.
Main Methods:
- Development and optimization of DARC technology and ANX776.
- Preclinical evaluation in models of glaucoma, optic neuropathy, AMD, Alzheimer's, Parkinson's, and diabetes.
- Phase 1 and Phase 2 clinical trials involving intravenous ANX776 administration in 129 patients.
- Analysis of DARC imaging data, including AI-aided algorithms, for disease prediction.
Main Results:
- Intravenous ANX776 has demonstrated safety and tolerability in clinical trials.
- Published results indicate DARC, combined with an AI algorithm, can predict disease activity in glaucoma and AMD.
- New analyses presented here focus on DARC's potential in predicting Geographic Atrophy (GA).
Conclusions:
- DARC technology shows promise as a biomarker for retinal diseases.
- Further validation in larger clinical studies is required for diagnostic or screening applications.
- Nasal administration, if feasible, could enhance DARC's acceptability as a future screening tool.
