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Verge Genomics Integrates Modality.AI into Phase 1b Clinical Trial for ALS Featuring Lead Drug Candidate VRG50635

Thursday, November 30, 2023

Verge Genomics, a biotechnology company in the clinical stage, is transforming drug discovery through the integration of artificial intelligence and human data. The company has announced that its Phase 1b proof-of-concept (POC) study for VRG50635, its lead drug candidate, will include Modality.AI. This marks the first use of an automated, clinically validated, multimodal system to evaluate speech and language patterns. VRG50635 is a small molecule inhibitor of PIKfyve in clinical development for amyotrophic lateral sclerosis (ALS) and is set to enter Phase 1b in the coming months.

Dr. Diego Cadavid, Chief Medical Officer at Verge Genomics, emphasized the importance of capturing objective data to quantify changes in speech during therapeutic trials for individuals with ALS. The gradual deterioration of vocal communication is a significant issue faced by many ALS patients. The incorporation of Modality.AI aims to provide insights into ALS disease progression by offering a more objective and comprehensive evaluation of speech.

Anil Tarachandani, Vice President and Head of Translational Medicine at Verge Genomics, expressed enthusiasm for integrating Modality.AI in their first ALS trial with VRG50635. The multimodal platform has been widely used in the ALS community and can potentially offer evidence of the efficacy of therapeutic interventions like VRG50635 by objectively measuring vocal communication.

Both Verge Genomics and Modality.AI leverage machine learning and proprietary datasets to optimize drug development. While Verge focuses on predicting new drugs with a higher probability of clinical success, Modality.AI's multimodal platform aims to enhance the efficiency of clinical trials by providing accurate insights into how these drugs may benefit ALS patients.

Modality.AI's platform produces objective speech measures by analyzing what patients say and how they say it, without the need for a clinician or special devices. This approach allows data collection not only in clinical settings but also in the convenience of patients' homes, using their own devices.

The collaboration with Modality.AI is part of Verge's efforts to improve patient data collection in the Phase 1b study for VRG50635. A previous partnership with Emerald Innovations involves incorporating wireless digital biosensors in participants' homes to continuously measure key neurological functions affected by ALS.

Traditional monitoring and data collection in ALS clinical trials often rely on subjective reporting, diaries, and questionnaires, coupled with periodic assessments in clinical settings. While providing useful information, these methods have limitations in precision and the ability to capture data in patients' home environments.



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