Newel Health scores $2.5M from MJFF for Parkinson’s app

Newel Health has been awarded a $2.5 million USD grant from the Michael J. Fox Foundation to support the development of Soturi, a Parkinson’s digital therapeutic co-developed with Orion Corporation.

Soturi has been under development for a few years. The app helps people with Parkinson’s collect data on their symptoms and progression, provides tools to help them manage the disease, then uses the information it collects, along with a proprietary algorithm, to make treatment recommendations to a treating physician or neurologist.

“The unfortunate fact in Parkinson’s is drugs don’t always work well for individuals. They also lose their efficacy over time,” Gerry Chillè, Newel’s chief strategy and innovation officer, told pharmaphorum. “So, being able to find what the right dose is to begin with, and then to fine tune that over time is a huge challenge in Parkinson’s disease.”

Data on motor symptoms (for instance, tremor, freezing in gait, and swaying) are detected with the help of a consumer wearable – a Garmin Vivosmart. But, in order to engage users and to collect additional useful data, the app also offers various tools: an exercise programme, a speech therapy programme, stress management resources, and medication management tools.

“This universe of data that we’re collecting is being used to develop an algorithm […] that says, for this person, given everything that’s going on with [them, their regimen] should be changed to this amount of medication and this frequency for them to be able to keep their symptoms more under control,” Chillè explained.

This kind of intervention is important because it presents a vast improvement on the current standard of care.

“When you consider that most people around the world who have access to good neurologists maybe see their neurologist once or twice per year, and then during those visits decisions are made on how to change their medication through trial and error, at this point, there isn’t really anything that can provide an objective, up-to-date, near real-time picture of what’s going on with that person,” Chillè said. “Also consider that a lot of people in the world don’t have the benefit of access to expert neurologists. So, a solution that can help local physicians and general practitioners will help them provide expert care to those patients.”

Next steps enabled by the grant

The Michael J. Fox Foundation grant is a statement of support not just for Newel Health and Orion’s work on Soturi, but for digital therapeutics more broadly: the vast majority of the foundation’s grant money goes towards biological research into Parkinson’s, towards the aim of finding a cure.

But even though, in the short term, Newel’s work with Soturi is focused on disease management, they could be helping in that goal as well, because the data collected in the project will be available to researchers through the MJFF’s open data initiative, Chillè said.

In the meantime, for Newel Health, the grant will allow them to advance some preliminary research.

“We’re going to have a small study with neurologists to see if they would follow the recommendations and if not, why not,” Chillè explained. “And there are various reasons why our recommendation might be correct, but not right for that specific person for a host of factors, and that’s why working alongside neurologists is going to be very important at this point.”

After that, they expect to start on a randomised control trial in 2025 that will - if all goes well - validate Soturi as a digital therapeutic.

“People will be using Soturi, and their therapy will be modulated and optimised according to Soturi’s recommendations and, of course, there will be an arm to that study of people following standard care,” Chillè said. “Hopefully the result from that study will prove that using Soturi will significantly improve the outcomes for those people with their current Parkinson’s therapy.”

What is Newel Health?

A recently de-stealthed company backed by Healthware Ventures, Newel Health is on a mission to create digital medicine and digital therapeutics products in strategic partnership with pharma companies and other healthcare stakeholders.

“We see ourselves as sort of a digital biotech,” Chillè said. “Biotechs will do research and development of a drug, will take it up to a certain phase of validation, up to a point where early data can start showing the promise and potential effectiveness of that solution. And usually this is the point where commercial partners come in.”

Newel aims to do the same thing with digital therapeutics. Soturi is one of several early projects from the company – others include Amicomed, a lifestyle management app for people with hypertension, and H.Core, a proprietary software framework that underpins DTx development.

“At Newel Health, we aim to create solutions like Soturi that can truly make a difference in people's lives, by harnessing the power of data and technology and keeping the human touch at the forefront of our products,” PierPaolo Iagulli, chief operating officer at Newel Health, said in a statement. “As we continue with this mission, H.Core, our proprietary software framework, propels us in accelerating the design, validation, production, and launch of all digital therapeutics and digital medicines.”

Chillè says that Newel Health is ready to consider other projects with anyone looking to be at the forefront of digital therapeutics.

“We’re certainly open to start a conversation with any of your readers in the pharma or insurance space, because we are ready to take on another challenging project in 2023 or 2024. We are staffed up for it,” Chillè said.