Verge Genomics to Incorporate Emerald Digital Health Technology into its ALS Phase 1b Proof-of-Concept Clinical Trial

May 23, 2023 |

4 min read

Verge Genomics announced that Emerald Innovations’ wireless digital health technology will be used to capture critical patient data in its planned Phase 1b proof-of-concept study of the PIKfyve inhibitor VRG50635, a novel therapeutic in clinical development for amyotrophic lateral sclerosis (ALS).

Emerald AI platform and “invisible” sensors to capture critical patient data and measure changes in clinical function in patients treated with VRG50635

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Verge Genomics a clinical-stage, tech-enabled biotechnology company pioneering the use of artificial intelligence (AI) and human data to transform drug discovery and development, announced that Emerald Innovations’ wireless digital health technology will be used to capture critical patient data in its planned Phase 1b proof-of-concept study of the PIKfyve inhibitor VRG50635, a novel therapeutic in clinical development for amyotrophic lateral sclerosis (ALS).

Through the collaboration, Emerald’s wireless digital health sensors will be placed in study participants’ homes to continuously measure key neurological functions affected by ALS, including sleeping, breathing, walking, and mobility. Analyses of the Emerald data will be used to assess changes in patients being treated with increasing doses of VRG50635.

“We are thrilled to be the first company to integrate Emerald Innovations’ technology into an ALS study. Given the high unmet need for effective treatments and the complexity of ALS, it is imperative that we leverage innovative technology tools that make it possible to collect dense amounts of unbiased, objective patient function data to properly assess the efficacy and dose-response to VRG50635 early in clinical development,” said Diego Cadavid, MD, Verge’s Chief Medical Officer.

“The partnership between Verge and Emerald stems from a shared commitment to establish a data-driven approach to clinical trials. This trial is designed from the outset to continuously and objectively track patients’ function and their potential change in response to treatment, without requiring them to wear sensors or alter their behavior,” said Dr. Dina Katabi, the President and co-founder of Emerald Innovations. “Analysis of this rich and objective data will yield insights to inform and optimize future phases. We believe such a data-driven approach is crucial for clinical trials in neuroscience, where objective biomarkers are very limited and most endpoints are subjective and noisy,” Dr. Katabi added.

The Emerald biosensor belongs to a new class of “invisible” sensors that operate in the background, and extract health metrics by analyzing the surrounding radio signals using AI, without requiring patients to use wearable devices or to manually record their experience. One of the greatest potential benefits of the Emerald digital health sensor is the ability to enhance traditional ALS clinical trial data by collecting objective patient data continuously or at regular intervals outside of office visits during a patient’s real-world activities to provide extensive, objective data for assessment of efficacy in clinical trials. Monitoring and data collection in ALS disease clinical trials traditionally involves 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 while having limitations in their precision and ability to capture data continuously rather than at brief moments in time.

Enrollment in the Phase 1b proof-of-concept Study of VRG50635 for treatment of ALS is anticipated to start in Q4 of 2023. VRG50635 is currently completing a Phase 1 clinical trial in healthy adult volunteers. More information about the Phase 1 study is available at: https://www.isrctn.com/ISRCTN14792372.

About Verge Genomics

Verge is focused on developing therapeutics for complex diseases with high unmet need, using human genomics and machine learning. Verge has created a proprietary all-in-human platform, featuring one of the field’s largest and most comprehensive databases of neurodegenerative multi-omic patient data. The company is led by experienced computational biologists and drug developers who are successfully advancing therapeutic programs in ALS and Parkinson’s disease toward the clinic. For additional information, please visit www.vergegenomics.com. Follow us on LinkedIn and Twitter.

About Emerald Innovations

Emerald Innovations is a health analytics company providing digital health solutions for passive, contactless in-home monitoring. Emerald makes the collection of statistically significant biomarkers easily accessible to its customers while providing ongoing insights into the status of clinical trials. Crucially, Emerald does this while enabling patients to comfortably go about their lives unconstrained by wearables. Emerald’s customers include the largest pharmaceutical companies in the world, Fortune 500 and innovative biotech companies, and major disease research foundations.