Annovis Taps AI Wearable Tech to Capture Real-World Parkinson's Data

MALVERN, PA – March 19, 2026 – Annovis Bio, a clinical-stage biotechnology company, has launched a significant initiative to modernize its Parkinson's disease (PD) research by integrating artificial intelligence and wearable technology into its ongoing Phase 3 study. The company announced a partnership with digital health firm NeuroRPM to deploy its FDA-cleared AI platform, which uses the Apple Watch to continuously monitor motor symptoms in patients, marking a pivotal shift from traditional, episodic clinical assessments to real-time, objective data collection.

The collaboration will see NeuroRPM's technology integrated into the ANVS-25002 study, a 36-month open-label trial evaluating buntanetap, Annovis's investigational oral therapy for neurodegenerative diseases. This move aims to provide researchers with an unprecedentedly granular view of how the disease and the potential treatment affect patients in their daily lives, a goal that has long been a challenge in neurology.

A New Paradigm for Clinical Trials

For decades, clinical trials for neurodegenerative diseases like Parkinson's have relied heavily on in-clinic evaluations, where physicians assess a patient's condition through standardized but subjective scoring systems like the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS). While valuable, these assessments provide only a brief snapshot of a patient's status, which can fluctuate significantly day-to-day or even hour-to-hour.

The partnership with NeuroRPM seeks to overcome this limitation by introducing the concept of a digital biomarker. The platform, which received FDA 510(k) clearance in March 2023, utilizes the motion sensors within a standard Apple Watch to passively and continuously collect movement data. Its proprietary AI algorithms then analyze this data to detect and quantify the cardinal motor symptoms of Parkinson's: bradykinesia (slowness of movement), tremor, and dyskinesia (involuntary movements).

This technology transforms a consumer device into a sophisticated medical monitor, capturing objective evidence of how a patient's symptoms change throughout the day and over the course of the 36-month study. This provides a continuous stream of real-world data, minimizing the patient burden associated with frequent clinic visits and eliminating the recall bias that can affect patient-reported outcomes.

“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 Atila Omer, CEO of NeuroRPM. “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.”

The Buntanetap Bet and a Dual-Biomarker Strategy

The drug at the center of the trial, buntanetap, represents a novel approach to treating neurodegenerative diseases. Rather than targeting a single pathological protein, the small molecule therapy is designed to inhibit the production of multiple neurotoxic proteins—including alpha-synuclein, amyloid beta, and tau—at their source. By targeting the mRNA that serves as the blueprint for these proteins, buntanetap aims to restore normal cellular function, reduce neuroinflammation, and ultimately halt or reverse disease progression.

Annovis is bolstering its innovative therapeutic approach with an equally innovative measurement strategy. In addition to NeuroRPM's digital biomarker, the ANVS-25002 study is also implementing a highly sensitive biological biomarker test. This minimally invasive skin procedure can detect misfolded phosphorylated alpha-synuclein—a defining pathological hallmark of Parkinson's disease—with what the company reports as greater than 90% diagnostic accuracy.

The combination of these two advanced biomarkers is what makes this trial design particularly noteworthy. It creates a powerful feedback loop, allowing researchers to potentially correlate real-world symptomatic changes captured by the wearable device with underlying biological changes in the disease pathology. This dual approach could provide a comprehensive picture of buntanetap's efficacy, assessing both symptomatic relief and potential disease-modifying effects.

“We are excited to collaborate with NeuroRPM 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,” said Cheng Fang, Ph.D., Senior Vice President of Research and Development at Annovis. “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.”

Navigating a Competitive Digital Health Landscape

Annovis Bio's adoption of wearable AI technology places it at the forefront of a major industry trend, but it is not alone. The field of digital biomarkers for Parkinson's is becoming increasingly competitive. Verily, Alphabet's life sciences arm, has been a pioneer with its Study Watch, and companies like Rune Labs have gained traction with their StrivePD platform, which also leverages the Apple Watch. Even pharmaceutical giant Roche has developed a digital biomarker solution that, in simulations, suggested the potential to dramatically reduce clinical trial sizes.

In this crowded space, NeuroRPM's specific FDA clearance for quantifying bradykinesia, tremor, and dyskinesia on a widely available consumer device serves as a key differentiator. It provides a layer of regulatory validation that is crucial for integration into pivotal clinical trials intended for drug approval submissions. By selecting an FDA-cleared platform, Annovis is signaling a commitment to regulatory-grade data quality, a move that could strengthen its position with both investors and health authorities.

This strategic adoption aligns with a broader push from regulatory bodies like the U.S. Food and Drug Administration, which has been actively encouraging the use of Digital Health Technologies (DHTs) to modernize clinical trials. The FDA has published guidance frameworks to help sponsors validate and implement these tools, recognizing their potential to generate more robust evidence, increase trial efficiency, and reduce patient burden.

This embrace of cutting-edge monitoring tools could prove essential in the high-risk, high-reward race to develop effective treatments for neurodegenerative diseases. By generating more precise and objective data, Annovis may be able to de-risk its clinical program for buntanetap and build a more compelling case for its efficacy. As the ANVS-25002 study, which has currently enrolled 90 of its planned 500 participants, continues, the insights gleaned from this synthesis of digital and biological markers will be closely watched by the entire neurology community, potentially setting a new standard for how future therapies are tested and validated.