Cambridge Cog Regulatory News (COG)

19 March 2020

Cambridge Cognition Holdings Plc

("Cambridge Cognition" or the "Company")

Cambridge Cognition awarded Innovative Medicines Initiative grant

with partners from industry and academia

Cambridge Cognition Holdings plc (AIM: COG), which develops and markets digital solutions to assess all aspects of cognition, is pleased to announce it is part of a successful consortium of 46 industry and academic partners who have collectively been awarded a prestigious Innovative Medicines Initiative ("IMI") grant. Led by the University of Newcastle, the consortium will work to identify digital endpoints for fatigue, sleep and activities of daily living in neurodegenerative disorders and immune-mediated inflammatory diseases. Cambridge Cognition will be the computerised cognitive assessment partner in the consortium and the proportion of the grant received by the Company is anticipated to be €150,000.

The IMI grant will fund a new European research project to Identify Digital Endpoints to Assess FAtigue, Sleep and acTivities of daily living (acronym: "IDEA-FAST") in the following neurodegenerative disorders: Parkinson's disease and Huntington's disease, and in the following immune-mediated inflammatory diseases: rheumatoid arthritis, systemic lupus erythematosus, primary Sjögren's syndrome, and inflammatory bowel disease; has been launched.

IDEA-FAST is a ground-breaking, €42 million digital health project co-funded by the European Union (represented by the European Commission) and the European pharmaceutical industry (represented by EFPIA, the European Federation of Pharmaceutical Industries and Associations) under the Innovative Medicines Initiative Joint Undertaking programme. It consists of 46 members from 14 different European countries, including Cambridge Cognition, pharmaceutical companies, academic and not-for-profit institutions, small- and medium-sized enterprises and patient organisations aiming to play complementary roles in achieving the agreed goals.

Fatigue and sleep disturbances are common and disabling symptoms that affect patients with neurodegenerative disorders and immune-mediated inflammatory diseases impacting on daily activities; they are the major causes of poor quality of life and increased healthcare cost. Current questionnaire-based approaches to measure these symptoms have key limitations preventing them from being used as reliable endpoints in clinical trials to evaluate the effect of therapies.

Based on the advancement of wearable and portable digital technology, IDEA-FAST aims to address these issues by identifying novel digital endpoints for fatigue, sleep disturbances and disabilities in daily activities. The final goal is to provide more objective, sensitive, reliable and ecological measures of the severity and impact of these symptoms in real-world settings. Such digital endpoints will eventually improve the efficiency of clinical trials, ultimately reducing the time and cost to bringing new therapies to patients.

The project, over its planned 66 month duration, will consist of two phases: an initial pilot study for testing and prioritising several digital devices and to identify candidate digital endpoints, followed by a large longitudinal study to validate findings for the most promising digital endpoints. The project will seek advice from regulatory agencies, including the European Medicines Agency, for the initial qualification of these digital endpoints. Patient users' perspective, data privacy, ethical, legal and other regulatory issues will be taken into consideration at all stages of the project.

Matthew Stork, Chief Executive Officer of Cambridge Cognition, said:

"With advances in digital technology, and the widespread adoption of devices, data on patients' functional outcomes can now be gathered at high-frequency in an objective and quantifiable manner. This offers huge potential for identifying and validating digital endpoints in clinical trials, and we are pleased to be the computerised cognitive assessment partner for this important collaborative initiative."

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Notes to Editors

About Cambridge Cognition

Originally developed at Cambridge University, CANTABTM technology has been continually enhanced by Cambridge Cognition for over a decade. CANTABTM technology has been extensively used in research, resulting in over 2,300 peer-reviewed research papers, more than any other computerized cognitive test. These include nearly three hundred publications in neurodegenerative inflammatory disorders. The technology includes secure, cloud-based servers for data storage and study management. The company has an excellent track record of translating neuroscience research into successful products for healthcare and clinical research. Cambridge Cognition have extensive experience in developing scientifically robust and engaging cognitive assessments on new technology platforms, including wearable devices, mobile phones and using automated speech recognition.

For the IDEA-FAST project, Cambridge Cognition will contribute digital tools for the assessment of the cognitive components of fatigue using both the CANTABTM battery and high-frequency brief assessments. They will also bring their expertise of cognitive assessments to bear on the data analysis effort.

https://www.cambridgecognition.com/

About IDEA-FAST

IDEA-FAST is led by Newcastle University, Great Britain, and University Hospital Schleswig-Holstein, Kiel, Germany as academic co-leaders, and by Janssen Pharmaceutica NV and Takeda Pharmaceuticals International as industry co-leaders.

See https://www.idea-fast.eu/ for more details.

About the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations

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 Commission and EFPIA.

See https://www.imi.europa.eu/ and https://www.efpia.eu/for more details.

Acknowledgement

This project has received funding from the Innovative Medicines Initiative 2 Joint Undertaking (JU) under grant agreement No 853981. The JU receives support from the European Union's Horizon 2020 Research and Innovation Programme and EFPIA and Parkinson's Disease Society of the United Kingdom LBG.