Digital biomarkers and treatment personalisation in multiple sclerosis

Project Information

dreaMS

Grant agreement ID: 867542

DOI

10.3030/867542

Project closed

EC signature date 6 May 2019

Start date 1 June 2019

End date 30 September 2019

Funded under

• INDUSTRIAL LEADERSHIP - Innovation In SMEs

Total cost

€ 71 429,00

EU contribution

€ 50 000,00

Coordinated by

HEALIOS AG
Switzerland

Periodic Reporting for period 1 - dreaMS (Digital biomarkers and treatment personalisation in multiple sclerosis)

Reporting period: 2019-06-01 to 2019-09-30

Summary of the context and overall objectives of the project

The Need: Multiple Sclerosis (MS) is one of the most common neurological disorders, which progression over 20 years leads to high patient disability and death. There are 2,5Mio patients diagnosed with MS in the world, mostly located in EU and North America. Neurologist monitor patients through typical biomarkers (clinical, biological ad imaging) but detection of disease progression remains unreliable, exposing patients to great risk of increased disability. Neurologists needs a reliable, cost-efficient and functional way to measure disease progression on an on-going basis.
Our solution: dreaMS aims to support precise diagnosis and treatment optimisation by developing a new type of biomarkers through the use of consumer devices and data science. The solution will result in improved patient outcomes and well-being and new health economic benefits for the health system.

The objectives of the SME Phase 1 project were focused on defining the technological, commercial and financial feasibility to achieve the next steps on development roadmap. Specifically, the present feasibility study has also been focused on the definition of EIC Accelerator project aiming to validate our solution as a software-based medical device class 2 meeting the regulatory requirements to obtain the CE marking, and thus, commercialize dreaMS in the European market by Q2 2022.

Work performed from the beginning of the project to the end of the period covered by the report and main results achieved so far

During the feasibility study, Healios successfully evaluated the technical, commercial and financial potential of the dreaMS project:
• Technical: Early lab testing was performed and conclusive in determining if sensor data from consumer devices can be used to measure change in motoric and fine motor skills patient with MS. Initial assessment of the AI capability was successfully completed.
• Commercial: Market analysis and in-person interviews with neurologists in the US, Switzerland and Spain concluded that millions of patients with MS would clearly benefit from it for everyday disease management and improved diagnosis. Regulatory analysis identified a clear pathway to CE Marking and FDA approval as class II Medical device.
• Market traction: We have received firm expression of interest from 4 leading global pharmaceutical companies active in MS (Roche, Novartis, Celgene, Merck). We also have received firm expression of interest from over 7 leading EU and US MS research centers representing over 200 neurologists and 5000 patients.
• Financial: 5-year financial projection post-commercial launch point towards a ROI of €46.20 per Euro invested and the creation of over 110 FTE’s in the EU

Progress beyond the state of the art and expected potential impact (including the socio-economic impact and the wider societal implications of the project so far)

2 major milestones have been identified in order to meet the validation requirements for dreaMS as a digital biomarker for everyday clinical usage:
• Study 1 – A short randomized clinical trial, with 60 participants (30 patients and 30 healthy subjects), with the goal to identify the most distinctive test value when comparing patient with MS and health subjects
• Validation study – A 18month observational study for regulatory purpose, to validate the test or a combination of tests against existing biomarkers (clinical, biological and imaging). This will involve at least 400 patients provided by the Swiss MS patient cohort currently manages by the university hospital of Basel.
Regulatory – The studies outcomes will require regulatory approval prior to dissemination. Regulatory steps need to be taken prior and after each of the studies to ensure to obtain CE marking.

Impact of the project:
1-Reduction of cost for EU healthcare systems: At present, there is no cure for MS. This disease represents a major public health issue with a substantial socioeconomic impact (€15.5 B annual costs in Europe) constituting the 2nd most expensive chronic illness. dreaMS aim to support neurologists make better decisions about which drugs fit best for their patient during the various stages of the disease progression. In addition, the global annual cost of MRI (clinical and research) for MS is $2 billion. MRI cost about 1000€ per scan and do not have good efficacy. dreaMS will result in using MRI only when absolutely needed and replace the routine use of MRI’s.
2-Improve efficiencies in health care systems: Currently neurologist see patients 1 or 2 times per year as a routine check, but when patient need immediate care, they go to the ER. dreaMS aims to change that by efficiently monitoring patient symptoms and allow neurologists to focus on the patients most at risk of a relapse and de-prioritize routine appointment.
3- Foster personal data collection for high quality care: The visibility of the results that will be achieved with the adoption of dreaMS solution will support the enhancement of patient acceptance of personal data collection for health monitoring, and lead to improved care and the development of new therapies for MS

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