Annovis Bio Deploys FDA-Cleared AI Biomarkers in 36-Month Parkinson’s Trial at 25 Sites
Annovis Bio has enrolled 90 of 500 patients across 25 U.S. sites in its 36-month open-label Parkinson’s trial testing oral therapy buntanetap with NeuroRPM’s FDA-cleared AI platform monitoring bradykinesia, tremor and dyskinesia. A minimally invasive skin assay for misfolded phosphorylated alpha-synuclein offers over 90% diagnostic sensitivity and specificity.
1. Trial Launch and Enrollment Status
Annovis Bio initiated the open-label ANVS-25002 study in Parkinson’s patients, enrolling 90 of the planned 500 participants across 25 U.S. sites to evaluate oral therapy buntanetap over a 36-month period.
2. AI-Enabled Digital Biomarker Partnership
The company partnered with NeuroRPM to integrate the first FDA-cleared AI-powered wearable system, enabling continuous real-time monitoring of core Parkinson’s symptoms—bradykinesia, tremor and dyskinesia—through motion data.
3. Skin-Based Biological Biomarker Implementation
A minimally invasive skin assay measuring misfolded phosphorylated alpha-synuclein with over 90% diagnostic sensitivity and specificity complements digital tracking by providing objective pathological evidence of disease.
4. Implications for Clinical Development
Combining continuous digital biomarkers with a high-accuracy biological assay aims to enhance real-world symptom tracking, strengthen evidence of disease progression and inform design and regulatory planning for future clinical trials.