MALVERN, PA — Annovis Bio, Inc. (NYSE: ANVS) has partnered with NeuroRPM to integrate an FDA-cleared artificial intelligence platform into its ongoing Parkinson’s disease study to improve symptom monitoring and data collection, the company announced.
The collaboration will incorporate a wearable, AI-enabled system into Annovis’ open-label Phase 3 study of its investigational therapy buntanetap, which is enrolling patients across 25 U.S. sites over a 36-month period.
The platform is designed to track core Parkinson’s symptoms, including bradykinesia, tremor, and dyskinesia, using continuous movement data collected in real-world settings. The data will be used as a digital biomarker to assess disease progression and treatment response during the study.
The ANVS-25002 trial has enrolled 90 of an expected 500 participants.
In addition to digital monitoring, the study includes a diagnostic biomarker test that measures misfolded phosphorylated alpha-synuclein through a minimally invasive skin procedure, providing pathological evidence associated with Parkinson’s disease.
Annovis said the combination of digital and biological biomarkers is intended to provide more comprehensive data on patient outcomes and disease progression.
Cheng Fang, senior vice president of research and development at Annovis, said the integration of the platform is intended to support data collection and monitoring throughout the trial. “The data generated in this open-label study, together with novel biomarkers, will produce a wealth of information and provide additional insights into our understanding of the disease trajectory,” Fang said.
Atila Omer, chief executive officer of NeuroRPM, said continuous monitoring allows for measurement of treatment effects in real-world conditions. “Continuous wearable monitoring enables objective measurement in real-world settings,” Omer said.
The company said the AI platform also supports medication tracking and passive data collection, reducing the burden on patients.
Participants in the study may have the option to continue using the monitoring technology after the trial through a prescription, according to the company.
Annovis is developing buntanetap as an oral therapy targeting multiple proteins associated with neurodegenerative diseases, including Alzheimer’s and Parkinson’s.
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