EverythingALS, Mitsubishi Pharma Join to Create Digital Biomarkers

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by Lindsey Shapiro, PhD |

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Note: This story was updated April 4, 2022, to clarify that 700 participants, including both ALS patients and healthy volunteers, have been recruited to the study.

Mitsubishi Tanabe Pharma America (MTHA) has joined EverythingALS’s consortium to accelerate the development of new digital biomarkers for amyotrophic lateral sclerosis (ALS).

While MTHA will provide support and funding for the project, the company will also have access to any generated data, which may help it advance its own clinical trials for ALS therapies.

“We are excited to participate in what we think is a new paradigm for successful drug development by building up digital biomarkers in ALS in collaboration with the ALS community,” Yasutoshi Kawakami, president of MTHA, said in a press release.

Biomarkers can serve several purposes including aiding in disease diagnosis and predicting outcomes. Digital biomarkers can take the form of digital devices, such as smartphones, computers, or watches to monitor for biological changes.

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Consistent with its mission to use technology to support the care and treatment of people with ALS, EverythingALS is focused on developing new ALS digital biomarkers.

“After my husband passed away from ALS in 2019, I was motivated to help in the pursuit and discovery of new digital biomarkers for ALS,” said Indu Navar, CEO and co-founder of EverythingALS, a U.S. nonprofit that is part of the Peter Cohen Foundation.

Last year, it collaborated with Modality.ai to develop a web-based computer program that uses audio and video recordings to monitor ALS progression through artificial intelligence (AI). The program is designed to identify speech problems, which are often among the first symptoms to emerge in ALS, and the data can be collected at home on any computer device. EverythingALS hopes the program can be used for early detection and to accurately predict prognosis.

“Through my ALS and high-tech connections, I was able to recruit a professional team with incredible direct experience with this disease and ties within the ALS community, to help support the world’s largest citizen-based, patient-centric ALS speech study as one of our first missions,” Navar said.

More than 700 participants have been recruited in the study so far, and early results show the program can identify significant differences in speech between healthy controls, pre-symptomatic patients, and symptomatic patients. Adult ALS patients and healthy volunteers are still being recruited.

“[EverythingALS] is well positioned to transform ALS research through direct patient involvement and remote data collection,” said James Berry, MD, an EverythingALS scientific advisory board member and ALS division chief at Massachusetts General Hospital.

“The speed with which EverythingALS has been able to recruit hundreds of participants in what has become the world’s largest AI-empowered speech study of people with ALS has vastly exceeded everyone’s expectations of what can be achieved,” Berry said.

EverythingALS is also collaborating with Microsoft to develop a model that predicts ALS based on people’s interactions with search engines (e.g. Google, Bing). Those interested in participating can contact the company here.

Meanwhile, MTHA’s oral formulation of edaravone, a potential ALS therapy, is currently under priority review for possible approval with the U.S. Food and Drug Administration.