Annovis Bio (ANVS) announced a partnership with NeuroRPM to implement a new FDA-cleared artificial intelligence platform that collects movement data for symptom and disease management in its ongoing Parkinson’s study. Annovis’ recently launched open-label study in PD patients is currently enrolling participants across the 25 sites in the United States to test buntanetap for the duration of 36 months. As part of the initiative to advance management, monitoring, and data collection, the Company has entered into a partnership with NeuroRPM to introduce the first FDA-cleared AI-enabled medical device that allows to monitor the primary PD symptoms – bradykinesia, tremor, and dyskinesia. This information will serve as a digital biomarker, capturing real-time evidence of how disease symptoms change during the course of the study. For the open-label study, in addition to the NeuroRPM’s digital biomarker assessing PD symptoms, Annovis is also implementing a highly accurate biomarker test for misfolded phosphorylated alpha-synuclein – a defining hallmark of Parkinson’s pathology. Measured via a minimally invasive skin procedure, the assay 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.
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