Annovis has partnered with NeuroRPM to deploy an FDA 510(k)-cleared AI platform that captures continuous movement data in its open-label ANVS-25002 Parkinson’s study, which is enrolling across 25 U.S. sites and will evaluate buntanetap over 36 months.
The NeuroRPM system is intended to detect core motor symptoms, including bradykinesia, tremor and dyskinesia and to produce a digital biomarker that records real-time symptom changes, the company says. Annovis is also implementing a skin-based assay for misfolded phosphorylated alpha-synuclein; the company claims the assay delivers objective pathological evidence with greater than 90% diagnostic sensitivity and specificity.
The ANVS-25002 study has enrolled 90 of an estimated 500 patients to date, and participants may be able to continue using NeuroRPM technology for clinical monitoring by prescription after the study. Annovis and NeuroRPM describe the combined digital and biological biomarker approach as a way to increase precision in measuring treatment response and disease trajectory in the ongoing trial.
