Ixico Regulatory News (IXI)

IXICO announces its real world study of Digital Biomarkers in people with dementia

31 March 2016, IXICO plc (Ticker: IXI) ('IXICO' or the 'Company'), the brain health company, today announces that John Hall, IXICO's SVP Commercial Operations, and Ken Tubman, IXICO's VP Health Technology, are delivering a presentation on Digital Biomarkers in Alzheimer's Disease at the Coalition Against Major Diseases (CAMD) Critical Path Institute's Digital Biomarkers Conference in Bethesda, Maryland, USA. The conference, titled "Use of Biosensors in Clinical Trials: Barriers & Solutions to the Current Landscape", will examine the current landscape of the use of Digital Biomarkers in clinical trials of neurodegenerative diseases, the challenges faced and the need for new solutions. 

IXICO's presentation describes how wearable devices and mobile phone apps are being used in Cygnus, a real world study of patients with symptoms of cognitive impairment and possible dementia. Cygnus has received favourable opinion from the Research Ethics Committee and recruitment is expected to commence shortly. 

Key objectives of the Cygnus study are:

· To evaluate the feasibility of web-based, mobile and wearable technologies as a means to collect high quality and actionable data from patients and their care givers;

· Linking these measurements to data about outcomes and episodes of care;

· To provide a well-characterised population who have consented to contact about future evaluation of technologies and interventions that might benefit patients and carers.

IXICO anticipates that the data collected in Cygnus will be used to support the qualification of Digital Biomarkers with regulators.

Professor Derek Hill, IXICO Chief Executive Officer, commented:

"We are delighted to have been invited to speak at this ground breaking conference. Wearable and mobile devices have the potential to not only advance, but also to transform clinical trials assessing treatments for dementia. Their success, we believe, will also lead to their uptake in clinical practice in the community. The Cygnus study highlights our continued expansion into a broader range of data capture technologies and builds on our existing contribution to public-private partnerships. It also demonstrates our commitment to be a centre of excellence for dementia research and a leading provider of digital technology in brain health."

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Notes to Editors

About IXICO

IXICO's innovative and proprietary digital healthcare technologies help those involved in researching and treating serious diseases to capture and analyse clinical data to make rapid, informed decisions. In clinical research this includes the phenotyping of patients, quantification of disease pathology and measurement of patient outcomes. In clinical practice the mobile health and digital decision support technologies aid diagnosis, patient engagement and monitoring. IXICO is also collaborating with partners to develop companion digital health products targeted at improving patient outcomes.

The Company's brain health focus includes Alzheimer's disease, Huntington's disease, multiple sclerosis, Parkinson's disease, behavioural health, child and adolescent mental health.

More information is available on www.ixico.com

About the Critical Path Institute and the Coalition Against Major Diseases

Critical Path Institute, founded in 2005 in Tucson, Arizona, is an independent, non-profit organization dedicated to bringing scientists from the FDA, industry and academia all together to collaborate and improve the drug development and regulatory process for medical products.

The Coalition Against Major Diseases (CAMD) is a public-private partnership led by the Critical Path Institute aims to develop, as a pre-competitive consortium, new technologies and methods to accelerate the regulatory science development and review of medical products for treating Alzheimer's Disease (AD) and dementias of related neurodegenerative diseases.

More information is available on www.c-path.org