Ixico Regulatory News (IXI)

IXICO launch UK Government funded project to further develop

Assessa® digital platform technology

Development of digital technologies to support accurate differential diagnosis of CNS diseases

12 May 2015, IXICO plc (Ticker: IXI) ('IXICO' or the 'Company'), the brain health company, today announces the launch of an Innovate UK grant funded project to support further development of its Assessa® medical device technology. 

The project will develop digital technologies to quantify vascular disease burden in patients with CNS diseases to support more accurate differential diagnosis of CNS diseases in the clinic, enabling the design and execution of better targeted clinical trials. Brain scan and clinical data from patients with vascular disease will be tested for different algorithms that automatically quantify a subject's vascular disease burden against current visual assessments. The developed vascular disease biomarkers will be incorporated into the Assessa® platform providing clinicians with information that is clinically actionable and easy to interpret.

As the lead partner, IXICO will be working alongside Imperial College London and Edinburgh University in the project which is part-funded by Innovate UK (formerly the Technology Strategy Board), the UK's innovation agency. The project is expected to run for two years with a total investment of just over £1 million.

Professor Derek Hill, Chief Executive of IXICO, commented:

"In current clinical practice, around one in five dementia patients suffering from vascular disease initially receive a misdiagnosis of Alzheimer's disease, resulting in potential mistreatment and excess costs. The selection of IXICO by Innovate UK as the lead partner for this project not only validates our market-leading digital dementia diagnosis platform, but also demonstrates the increasing demand for digital technology to support traditional diagnoses. We believe that the use of stratification tools to provide a more personalized diagnosis of patients with vascular causes of dementia should improve patient outcomes and reduce the cost burden."

Assessa®

Assessa® is a CE marked medical device to support accurate diagnosis of dementia through the automated quantitative assessment of structural brain MRI in combination with other clinical data such as demographics and information from genetic, biochemical, cognitive and functional tests. Assessa® is a web-based digital platform and is accessible to clinicians in Europe and Canada. IXICO is expanding the application of the Assessa® digital platform to other CNS diseases and has also developed a research version to enable the enrichment and stratification of dementia patients in clinical trials through the application of predictive and prognostic combination biomarkers.

Clinical need

The importance of early detection of dementia has been highlighted by different programmes and initatives worldwide, including by the UK Prime Minister's Dementia Challenge. Although Alzheimer's disease has the highest prevalence (~65%) and has been the main focus of drug development, it is estimated that 30% of dementia cases may have a vascular component. While both Alzheimer's disease and vascular dementia show some similar clinical symptoms, the differences in the underlying pathology are likely to require systematically different therapeutic strategies and management. For example, cholinesterase inhibitors may provide symptomatic benefit in Alzheimer's disease but have no benefit in vascular dementia, where a prevention of recurring stroke through the treatment of risk factors can be effective, and more aggressive treatment of neurovascular disease might be beneficial.

At the early stages of the disease it is easy to misdiagnose the main causes of dementia symptoms and this may be one reason for the difficulty in finding effective treatment. Therefore accurate stratification of disease types, based on quantitative biomarkers, is crucial for objective diagnosis, stratification in clinical trials and in future, treatment and care management. 

For drug companies developing new treatments for dementia, a good understanding of vascular disease burden and its progression is important, both for the development of treatments that specifically target vascular dementia, but also for the development of treatments for AD. Many drugs targeting one of the key components of Alzheimer's disease pathology, amyloid, can cause side effects that can be visualised on MRI scans known as Amyloid Related Imaging Abnormalities. Early identification and ongoing monitoring of these abnormalities are important for the safe evaluation of treatments in clinical trials and will also be a key regulatory requirement for the safe use of these treatments in the clinic, similar to the use of disease modifying treatments for Multiple Sclerosis.

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About IXICO

IXICO, the brain health company, uses its innovative and proprietary digital health technologies to help those involved in researching and treating serious diseases to make rapid, informed decisions targeted at improving patient outcomes. IXICO has significant experience working with global pharmaceutical and biotechnology companies supporting clinical studies in the field of neuro-degenerative disorders including Alzheimer's disease, Huntington's disease, other causes of dementia and Multiple Sclerosis.

More information is available on www.ixico.com