Verge Genomics Will Use Modality.AI in Its ALS Phase 1b Clinical Trial of Its Lead Drug Candidate VRG50635

Modality’s multimodal AI platform will capture critical speech and language changes

SOUTH SAN FRANCISCO, Calif., Nov. 29, 2023 (GLOBE NEWSWIRE) -- Verge Genomics, a clinical-stage biotechnology company transforming drug discovery using artificial intelligence and human data, announced that its Phase 1b proof-of-concept (POC) study of its lead drug candidate, VRG50635, will incorporate Modality.AI, the first automated, clinically validated, multimodal system to assess speech and language patterns. VRG50635 is a potential best-in-class small molecule inhibitor of PIKfyve that is in clinical development for amyotrophic lateral sclerosis (ALS) and is expected to move into Phase 1b in the coming months.

“Gradually deteriorating vocal communication is one of the major issues many people with ALS experience. It is, therefore, crucial for us to capture objective data to quantify changes in speech during therapeutic trials and explore how this data can be used to better understand the potential benefits of VRG50635,” said Diego Cadavid, M.D., Chief Medical Officer at Verge Genomics.

“Endpoints used in ALS trials are often subjective, biased, and only limited objective biomarkers of neurological function are available. We are enthusiastic to incorporate Modality.AI in our first ALS trial with the PIKfyve inhibitor, VRG50635, because their multimodal platform has been extensively used by the broader ALS community and can provide insights into ALS disease progression,” said Anil Tarachandani, Ph.D., Vice President and Head of Translational Medicine at Verge Genomics. “There are several publications already on the ability of Modality’s platform to measure vocal communication in ALS. Using speech as an objective endpoint in ALS trials can provide evidence of the efficacy of potential therapeutic interventions, such as VRG50635.”

“At the core of both Verge Genomics and Modality.AI is the use of machine learning in combination with proprietary data sets to optimize drug development. While the Verge platform is designed to predict new drugs with a higher probability of clinical success, Modality.AI’s multimodal platform reduces inefficiencies in clinical trials of these new drugs, increasing the success probability even further by delivering more accurate and comprehensive insights into how these drugs may benefit people with ALS,” said David Suendermann-Oeft, Ph.D., Founder and CEO of Modality.AI.

Modality.AI’s multimodal platform produces objective speech measures by analyzing what patients say, and how they say it, without a clinician present and without any special devices. A great advantage of this approach, particularly for ALS patients, is the ability to collect data not only at the clinic but also in the convenience of their homes, where they can use their own devices, such as a laptop or smartphone.

The collaboration with Modality.AI builds on Verge’s efforts to enhance how patient data will be collected in its Phase 1b study for VRG50635. Earlier this year, Verge announced a partnership with Emerald Innovations that will incorporate Emerald’s wireless digital biosensors in study participants’ homes to continuously measure key neurological functions affected by ALS, including sleeping, breathing, walking, and mobility.

Monitoring and data collection in clinical trials for ALS traditionally involve subjective patient or physician reporting that includes diaries and questionnaires coupled with periodic neurological and mobility assessments in a clinical setting. These procedures provide useful information but have limitations in their precision and ability to capture data at patients’ homes.

VRG50635 completed a Phase 1 single- and multiple-ascending dose clinical trial in healthy volunteers in June 2023. More information about the Phase 1 study is available at:

About Verge Genomics
Verge Genomics is focused on developing therapeutics for complex diseases with high unmet need, using human genomics from patient disease tissues and machine learning. Verge has created the proprietary all-in-human CONVERGE® platform, featuring one of the field’s largest and most comprehensive databases of multi-omic patient data. The company is led by experienced computational biologists and drug developers who are successfully advancing clinical and preclinical therapeutic programs in various diseases, including ALS and Parkinson’s disease. For additional information, please follow us on LinkedIn and Twitter/X.

About Modality.AI
Modality.AI provides technology for the objective assessment of CNS conditions through automated speech, language, and visual analytics of conversations elicited by Tina, a virtual assistant. Modality.AI is led by a team of world-class scientists, clinicians, technologists, and serial entrepreneurs. The company’s multimodal platform has shown validation through numerous peer-reviewed publications and is being used in many observational and interventional studies by top-10 pharmaceutical companies, biotech and medtech firms, leading research institutions, and the federal government. For additional information, please visit Follow us on LinkedIn and Twitter/X.

Adam Silverstein
Scient PR

David Fox