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Sci Rep2026;16(1)April 14, 2026Journal Article

Speech-based digital endpoints track ALS progression and align with standard clinical outcomes: evidence from the VRG50635 trial.

Michael Neumann1, Hardik Kothare2, Meredith Bartlett2, Oliver Roesler2, Christiane Suendermann-Oeft2, Abhishek Hosamath2, Lakshmi Arbatti2, David Pautler2, David Suendermann-Oeft2, Diego Cadavid3, Robert H Scannevin3, Ines Hoffmann3, Anil Tarachandani3, Tara Haley3, Shane Raines4, Philip Van Damme5, Pentti Tienari6, Eino Solje7, Manu Jokela8, Angela Genge9, Colleen O'Connell10, Ruben P A van Eijk11,12, Leonard H van den Berg11,12, Vikram Ramanarayanan13,14
1Modality.AI, San Francisco, CA, USA. michael.neumann@modality.ai.
2Modality.AI, San Francisco, CA, USA.
3Verge Genomics, South San Francisco, CA, USA.
42b Analytics, Wallingford, PA, USA.
5Department of Neurology, and Department of Neuroscience, University of Leuven (KU Leuven), Leuven, Belgium.
6Helsinki University Hospital, Helsinki, Finland.
7Institute of Clinical Medicine - Neurology and Kuopio University Hospital, Neuro Center - Neurology, University of Eastern Finland, Kuopio, Finland.
8Turku University Hospital, Turku, Finland.
9The Neuro - Montreal Neurological Institute Hospital, Montreal, Canada.
10Stan Cassidy Centre for Rehabilitation, Fredericton, Canada.
11Utrecht University Medical Center, Utrecht, Netherlands.
12Treatment Research Initiative to Cure ALS (TRICALS), Utrecht, Netherlands.
13Modality.AI, San Francisco, CA, USA. Vikram.ramanarayanan@modality.ai.
14University of California, San Francisco, CA, USA. Vikram.ramanarayanan@modality.ai.
PubMed PMC DOI PDF

Abstract

We report on the utility of speech-based digital endpoints measured during a Phase 1b study of VRG50635 in Amyotrophic Lateral Sclerosis (ALS). Fifty-four participants with ALS were enrolled and participated in an 8-week pretreatment run-in, followed by three 8-week dosing periods and an 8-week follow-up. They completed a speech assessment every two weeks in the clinic or at home. We observed mode…

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