Ad Scientiam starts patient enrollment in HARMONY 360 study

Ad Scientiam has enrolled the first patient in HARMONY 360, a 12-month European study with Merck KGaA, Darmstadt, Germany, to test remote digital monitoring in adults with generalized Myasthenia Gravis. The study could shape how the investigational MyoSense 360 device is refined and used in future confirmatory research.

Why it matters: - HARMONY 360 is testing whether remote, multimodal digital monitoring can detect disease changes in generalized Myasthenia Gravis outside clinic visits. - The study could support future device optimization and broader scaling of the MyoSense 360 platform. - Better real-world monitoring may help clinicians track a severe, fluctuating neuromuscular disease more continuously.

What happened: - Ad Scientiam enrolled the first patient in the HARMONY 360 study. - The prospective, multi-center, exploratory clinical study is being run with Merck KGaA, Darmstadt, Germany. - The study is designed to assess the feasibility of multimodal, remote digital monitoring in adults with generalized Myasthenia Gravis using the investigational medical device MyoSense 360. - The study covers 100 adults across 20 investigating sites in France, Germany, Italy, Spain and Denmark.

The details: - The study follows participants for 12 months. - HARMONY 360 combines on-site clinical assessments with continuous digital data collection. - Traditional assessments include the Quantitative Myasthenia Gravis test. - The investigational MyoSense 360 platform includes passive monitoring through a wearable device, the ActiGraph LEAP. - The wearable captures physical activity, sleep, heart rate and respiratory rate. - The platform also includes monthly smartphone-based functional tests in the morning and evening. - Those tests assess ptosis, dysarthria, upper and lower limb weakness and respiratory muscle weakness. - The study collects electronic patient-reported outcomes on participants' smartphones. - The ePROs include MG-ADL, MG-QoL15r, fatigue measured with NeuroQoL, infection tracking and additional questionnaires. - Data collection is intended to work under real-life, unsupervised conditions.

Between the lines: - The move from study design to enrollment signals that the operational phase is now underway across European sites. - The model reflects a shift toward decentralized data capture, which can provide more frequent signals than point-in-time visits. - The study design also suggests Ad Scientiam is building evidence for a future confirmatory study, not just testing feasibility. - Lissandra Klaeylé, head of clinical operations at Ad Scientiam, said the transition marks a pivotal operational shift and gives clinicians and patients continuous, objective metrics that point-in-time visits cannot capture.

What's next: - Insights from HARMONY 360 will inform device optimization, algorithmic refinement and protocol scaling. - Those findings are expected to guide the design of a future confirmatory study. - Ad Scientiam will continue validating digital biomarkers across disease areas, including neuroscience, rare diseases and mental health.

The bottom line: - Ad Scientiam has moved HARMONY 360 from planning to live enrollment, advancing a European test of remote digital monitoring for generalized Myasthenia Gravis.