107th Edition – December 2020

One step closer: digital readouts of walking as a measure of health

Reduced walking speed is a sign of many health conditions. The Mobilise-D project wants to make continuous digital measurements of the way a person walks, gathered using wearable sensor technology, accepted as valid indicators of their state of health, much in the same way as blood pressure readings or oxygen levels are. Now the project has received an early public nod of support for their working methods and plans from the European regulator, the European Medicines Agency (EMA).

Mobilise-D’s mission is to get these digital mobility outcomes, or DMOs, ‘qualified’ to be used as biomarkers in clinical trials. It’s an ambitious goal and they are using five different diseases as test cases. The letter of support – an intermediary sign of encouragement from the EMA on the way to full qualification - is important because it demonstrates not only the promise of the innovation, but also how important it is to build rapport with the regulating authorities early, something IMI encourages in all our funded research.

At the very start of Mobilise-D, the consortium made a strategic plan on how to get regulatory acceptance for DMOs. They decided to interact with the EMA very early on by submitting a request for qualification advice, and to take an incremental approach, starting with qualification advice of monitoring biomarkers in Parkinson’s disease.

Early interactions with regulators are particularly valuable in young and evolving fields like digital health technologies, where the regulatory framework is still under development and many things are still uncertain. The consortium’s step-by-step approach is also critical for maximising the chances of success, because it allows them to refine their plans as they gain more knowledge. With this positive feedback, Mobilise-D can progress confidently with their work.

Find out more

• Read the article in full
• Join in the discussions on Mobilise-D’s Slack channel #dHealth4Trials

IMI supported antibiotic passes Phase I clinical trials

A study in healthy volunteers showed that the antibiotic EBL-1003 is safe and well tolerated. EBL-1003 (a purified form of apramycin) shows promise as a treatment for complex drug-resistant infections. The finding is a great result for the ENABLE project, which set up an antibiotic development platform to provide researchers with the expertise, resources and support needed to advance promising early research stage antibiotics into Phase 1 clinical trials in humans.

The clinical potential of apramycin was discovered by researchers at the University of Zurich who set up a spin-out company, Juvabis, to develop it further. Juvabis joined ENABLE in 2016. Thanks to the collaboration with ENABLE, Juvabis was able to demonstrate the safety and efficacy of in animal models for various infections, including infections caused by some of the more dangerous drug-resistant bacteria.

The Phase I clinical trial started in 2019; the goal of the trial was to assess the safety and tolerability of the drug as well as how it behaves in the body. Healthy volunteers received single intravenous doses or a placebo.

The results of that trial are now in, and they show that EBL-1003 is both safe and well tolerated. The Juvabis team now plans to run a further Phase I trial in patients with complicated urinary tract infections – one of the disease areas where EBL-1003 shows the most promise.  

If further trials confirm EBL-1003’s antibiotic abilities, it would be a valuable weapon for treating infections involving bacteria that are increasingly resistant to many existing antibiotics.

‘We urgently need new antibiotics to tackle the ever-growing threat of antimicrobial resistance. ENABLE’s successes demonstrate that with the right support from a team of experts from academia and industry, potential antibiotics can be identified and supported through the highly challenging early stages of antibiotic development,’ said IMI Executive Director Dr Pierre Meulien. ‘More broadly, this result demonstrates the strength of public-private partnerships in tackling major health challenges.’

Find out more

• Read the article in full
• Read ENABLE’s press release
• Visit the ENABLE website

RADAR-CNS turns symptoms into dance for Science in the City Malta festival

RADAR-CNS is investigating how wearable technologies and mobile phones can track and help prevent depression, epilepsy and multiple sclerosis. Now, the project has teamed up with dancers, musicians and technology experts to portray in dance symptoms which may be hard to express in words. The result is Feedback Loops, which was performed at Science in the City, Malta’s national science and arts festival.

The performance responds to a quote from a member of the RADAR-CNS Patient Advisory Board: ‘A lot of my symptoms are invisible and people find it hard to understand what I’m going through.’

‘With slow, forceful heaviness as an overriding movement quality throughout the piece, I have depicted some of the visible and invisible symptoms of depression,’ says dancer Anna Spink. ‘I have included changes of focus, lower planes of motion and specific gestures to abstractly demonstrate guilt, difficulty making decisions and feeling “itchy” or uncomfortable in one’s own skin.’

Dan Wimperis explains the music: ‘Throughout the performance the dancer’s movements controls which notes are being played, the blood volume pulse (the graph on a heart rate monitor) is controlling the probability of notes being played and the volume of the notes (how hard a pianos key is pressed) and the electrodermal activity (the amount of sweat on their skin) is controlling how the notes sound, either bright or dark, far away or close etc.’

‘It’s been such an exciting project to work on with collaborators based in London, Bristol and Milan,’ says producer Alina Ivan of the RADAR-CNS project, who is based at King’s College London. ‘It has been very satisfying to have this shared intellectual space where we could share ideas (especially throughout the lockdown!) and work towards a shared goal!’

Find out more

• Read the RADAR-CNS news item
• Watch a recording of the performance (starts at 10m30s)