Ixico Regulatory News (IXI)

16th November 2016

IXICO plc

("IXICO" or the "Company")

IXICO to receive €100k funding to provide digital technologies for collection and analysis of data in a "real world" setting

Further expansion of work on wearable bio-sensors as part of a major EU public-private partnership (ROADMAP)

IXICO, the brain health company, today announces its participation in a new collaborative pan-European research effort under the Innovative Medicines Initiative's (IMI) umbrella focused on addressing the challenges of successfully delivering therapies to people with Alzheimer's disease (AD).

In this collaboration with leading pharmaceutical companies and academics, IXICO is receiving €100k of funding to undertake data aggregation and analysis using its digital technology platforms. The platforms will be used to devise clinically meaningful measurements from biosensors worn by patients, and to develop enhanced models of disease progression to help select the most appropriate treatment for an individual patient. Within ROADMAP, IXICO will demonstrate how both approaches can be deployed in real-world settings, leveraging IXICO's existing activities in the Cygnus real world evidence (RWE) study (http://www.ixico.com/news/2016/06/ixico-cygnus-joins-DPUK).

Derek Hill, CEO of IXICO, said: "IXICO is delighted to be joining the ROADMAP consortium. It provides an excellent opportunity for us to advance our capabilities in wearable biosensors and digital disease models, working collaboratively with leading pharmaceutical companies and academics. These are key technologies that are likely to accelerate the approval of and access to beneficial treatments for AD, and we believe they will provide commercial growth opportunities for IXICO."

This project will enhance capabilities currently integrated into IXICO's TrialTracker™ and Assessa® digital health platforms, which are used by pharmaceutical companies both to support development of new treatments and used alongside marketed drugs. This innovative collaboration brings together 22 leading academic, healthcare and pharmaceutical partners, including Novartis Pharma AG, Eli Lilly and Company Ltd, Biogen, F. Hoffman-La Roche Ltd, Janssen Pharmaceutica NV, GE Healthcare Ltd and AC Immune SA. ROADMAP is also looking to identify which combinations of clinical tests and biomarkers support accurate diagnosis and prognosis of disease in asymptomatic patient populations in Alzheimer's disease. 

For further information please contact:

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 ROADMAP

ROADMAP aims to provide the foundation for a much-needed integrated data environment and framework for Real World Evidence (RWE) in AD including:

· The development of consensual key outcome measures across stakeholder groups;

· Enabling data integration tools for dataset characterisation and outcome classification, data standards, data sourcing, software application repository;

· Guidelines on the handling and interpretation of RWE data.

In addition, the following priorities have been identified:

· Outcome measurement;

· Identifying the best natural history model;

· Identifying the best pharmacoeconomic modelling strategy;

· Using short-term data to model long-term effects;

· Using short-term data to model long-term economic impact;

· Association between cognition, QoL (quality of life) and function over the AD spectrum;

· Identifying combination markers for diagnosis in asymptomatic patient population;

· Identifying combination markers for prognosis.

ROADMAP is mainly sponsored by the European Union's Horizon 2020 research and innovation programme and the European pharmaceutical industry (via EFPIA) under the auspices of the Innovative Medicines Initiative 2 Joint Undertaking.

The ROADMAP programme has budget of €7.77M distributed across a total of 22 partners from the private and academic sectors:

About the Innovative Medicines Initiative

The Innovative Medicines Initiative (IMI) is Europe's largest public-private initiative aiming to speed up the development of better and safer medicines for patients. IMI supports collaborative research projects and builds networks of industrial and academic experts in order to boost pharmaceutical innovation in Europe. IMI is a joint undertaking between the European Union and the European Federation of Pharmaceutical Industries and Associations, EFPIA.

More information can be found at www.imi.europa.eu

Acknowledgement

The project leading to this application has received funding from the Innovative Medicines Initiative 2 Joint Undertaking under grant agreement No 116020. This Joint Undertaking receives support from the European Union's Horizon 2020 research and innovation programme and EFPIA

Disclaimer

This communication reflects the views of the ROADMAP Consortium and neither IMI nor the European Union and EFPIA are liable for any use that may be made of the information contained herein.