Annovis Bio Partners with NeuroRPM to Deploy AI-Powered Digital Biomarker Technology in Parkinson's Disease Clinical Trial
Key Insights
Annovis Bio has partnered with NeuroRPM (search) to implement FDA-cleared AI-enabled digital biomarker monitoring in its ANVS-25002 Parkinson's disease (search) clinical trial using Apple Watch technology.
The NeuroRPM (search) platform continuously monitors key Parkinson's motor symptoms including bradykinesia (search), tremor (search), and dyskinesia (search) during daily activities to complement traditional clinical assessments.
The 36-month open-label study aims to enroll 500 participants across 25 U.S. sites to test buntanetap, with 90 patients currently enrolled.
Annovis Bio has announced a strategic partnership with NeuroRPM (search) to deploy AI-powered digital biomarker technology in its ongoing Parkinson's disease (search) clinical trial, marking a significant advancement in real-world symptom monitoring for neurodegenerative disease research.
FDA-Cleared Digital Monitoring Platform
The collaboration will integrate NeuroRPM (search)'s FDA-cleared wearable platform into Annovis Bio's ANVS-25002 open-label Parkinson's disease (search) clinical trial. The platform utilizes Apple Watch technology to passively collect and analyze movement data during daily activities, providing continuous measurement of key Parkinson's motor symptoms including bradykinesia (search), tremor (search), and dyskinesia (search).
"Parkinson's is experienced in everyday life, so researchers need tools that show what happens between scheduled assessments," said Atila Omer, CEO of NeuroRPM (search). "Using Apple Watch to gather continuous movement data during daily life, we can translate those patterns into meaningful insights for researchers evaluating how therapies perform and affect individual patients in the real world."
Addressing Clinical Assessment Limitations
The partnership addresses a critical gap in Parkinson's disease (search) research, where symptoms often fluctuate throughout the day and vary across patients, making treatment response difficult to fully characterize through periodic in-clinic assessments alone. NeuroRPM (search)'s technology represents the first FDA-cleared AI-enabled medical device for continuous monitoring of Parkinson's disease symptoms.
The ANVS-25002 study is expected to enroll approximately 500 participants with Parkinson's disease (search) across 25 clinical sites in the United States over a 36-month duration. The study has currently enrolled 90 out of the estimated total 500 patients. Eligible participants may choose to participate in the NeuroRPM (search) digital monitoring program to complement scheduled study assessments with continuous real-world symptom monitoring.
Comprehensive Biomarker Approach
Beyond digital monitoring, Annovis is implementing a dual biomarker strategy in the open-label study. In addition to NeuroRPM (search)'s digital biomarker technology, the company is utilizing a highly accurate biomarker test for misfolded phosphorylated alpha-synuclein (search), a defining hallmark of Parkinson's pathology. This assay, measured via a minimally invasive skin procedure, delivers objective pathological evidence of the disease with greater than 90% diagnostic sensitivity and specificity.
"The combination of cutting-edge digital and biological biomarkers used in tandem opens a unique opportunity to comprehensively record patients' response to treatment – changes in symptoms and potential disease-modification – bringing greater precision and depth to the measurement of outcomes in the ongoing open-label PD trial," according to the company announcement.
AI-Powered Real-World Evidence
The NeuroRPM (search) platform offers several key benefits for clinical research, including AI-powered real-time detection of core Parkinson's symptoms, improved patient access via mobile and wearable applications, medication tracking and schedule reminders, and passive data collection that minimizes patient burden. The technology enables enhanced understanding of treatment response in everyday life settings.
"Understanding the real-world impact of a therapy like buntanetap is a sophisticated task, particularly when treatment effects may unfold over multiple timescales across a highly variable patient population," commented Omer. "Continuous wearable monitoring enables objective measurement in real-world settings, helping researchers develop a more granular understanding of treatment response and a stronger evidence base for how a therapy is performing in daily life."
Clinical Trial Context
The ANVS-25002 study is testing buntanetap, Annovis Bio's investigational once-daily oral therapy that inhibits the translation of multiple neurotoxic proteins, including APP and amyloid beta (search), tau (search), alpha-synuclein (search), and TDP-43, through a specific RNA-targeting mechanism of action. The company aims to halt disease progression and improve cognitive and motor functions in patients by addressing underlying causes of neurodegeneration.
"We are excited to collaborate with NeuroRPM (search) and believe that data-driven insights generated from its platform will complement our existing data collection and strengthen the evidence-based monitoring of disease progression throughout the trial," commented Cheng Fang, Ph.D., Senior Vice President, Research and Development at Annovis.
Maria Maccecchini, Ph.D., President and CEO of Annovis, emphasized the transformative potential of AI in disease management: "We are living in an era where AI has moved beyond useful to essential, and disease management stands among the most transformative opportunities for its application. We are proud to partner with NeuroRPM (search) to bring into our study the AI-powered digital biomarker for monitoring Parkinson's symptoms, adding an important layer of evidence-based measurement of disease progression throughout the trial."
Following the study completion, participants may have the option to continue using NeuroRPM (search) technology for clinical monitoring by prescription, potentially extending the real-world benefits of continuous symptom monitoring beyond the research setting.